Seizure Tracker - Clinical Trial Finder

Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)

Brief Summary: Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated. This study will focus on patients that are already implanted with the HEARO robotic system.

Recruiting

Start Date:
2022-03-01

Close Date:
2025-02

Interventions:

DEVICE: Post-operative ABF followed by fitting according to clinical standard
DEVICE: Fitting according to clinical standard followed by post-operative ABF

Recruiting

Start Date:
2022-03-01

Close Date:
2025-02

Interventions:

DEVICE: Post-operative ABF followed by fitting according to clinical standard
DEVICE: Fitting according to clinical standard followed by post-operative ABF

ClinicalTrials.gov

Patterns of Neonatal Seizures

Brief Summary: Study the pattern of neonatal seizures in neonatal intensive care unit at Assiut university children's hospital along year from (Oct.2025-Oct.2026)

Not yet recruiting

Start Date:
2025-10-01

Close Date:
2026-11-01

Not yet recruiting

Start Date:
2025-10-01

Close Date:
2026-11-01

ClinicalTrials.gov

Evaluating the Role of Inflammation in Neonatal Epileptogenesis

Brief Summary: The purpose of this study evaluate the relationship between inflammation and epilepsy in neonates with seizures after birth.

Active, not recruiting

Start Date:
2018-12-15

Close Date:
2025-12-01

Interventions:

DIAGNOSTIC_TEST: Blood draw
OTHER: Survey

Active, not recruiting

Start Date:
2018-12-15

Close Date:
2025-12-01

Interventions:

DIAGNOSTIC_TEST: Blood draw
OTHER: Survey

ClinicalTrials.gov

Quantifying the Benefits and Cost-effectiveness of Real-Ear Measurements (REM) for Hearing Aid Fitting

Brief Summary: Adjusting hearing aid user's real ear performance by using probe-microphone technology (real ear measurement, REM) has been a well-known procedure that verifies whether the output of the hearing aid at the eardrum matches the desired prescribed target. Still less than half of audiologists verify hearing aid fitting to match the prescribed target amplification with this technology. Recent studies have demonstrated failures to match the prescribed amplification targets, using exclusively the predictions of the proprietary software. American Speech-Language-Hearing Association (ASHA) and American Academy of Audiology (AAA) have created Best Practice Guidelines that recommend using real-ear measurement (REM) over initial fit approach and also the recent ISO 21388:2020 on hearing aid fitting management recommends the routine use of REM. Still audiologists prefer to rely on the manufacturer's default "first-fit" settings because of the lack of proof over cost-effectiveness and patient outcome in using REM. There are only few publications of varying levels of evidence indicating benefits of REM-fitted hearing aids with respect to patient outcomes that include self-reported listening ability, speech intelligibility in quiet and noise and patients' preference. Our main research question is whether REM-based fitting improves the patient reported outcome measures - PROMs (SSQ, HERE) and performance-based outcome measures (speech-reception threshold in noise) over initial fit approach. An additional research question is whether REM-based fitting improves hearing aid usage (self-reported \& log-data report). Eventually, the investigators will calculate the cost-effectiveness of REM-based fitting.

Active, not recruiting

Start Date:
2022-09-07

Close Date:
2025-08-31

Interventions:

OTHER: Hearing Aid Manufacturer's Software
OTHER: REM (Real Ear Measurements)

Active, not recruiting

Start Date:
2022-09-07

Close Date:
2025-08-31

Interventions:

OTHER: Hearing Aid Manufacturer's Software
OTHER: REM (Real Ear Measurements)

ClinicalTrials.gov

Effect of GABA on ADHD and Seizures in Children With Epilepsy.

Brief Summary: Effect of GABA on ADHD and seizures in Children with epilepsy.

Recruiting

Start Date:
2018-07-01

Close Date:
2028-12-01

Interventions:

DRUG: GABA

Recruiting

Start Date:
2018-07-01

Close Date:
2028-12-01

Interventions:

DRUG: GABA

ClinicalTrials.gov

BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures

Brief Summary: The purpose of this study is to examine safety signals and demonstrate seizure reduction in adults with FIAS treated with BIS-001ER as an add-on therapy in an in-patient and out-patient study design.

Active, not recruiting

Start Date:
2018-04-10

Close Date:
2026-12-30

Interventions:

DRUG: BIS-001ER

Active, not recruiting

Start Date:
2018-04-10

Close Date:
2026-12-30

Interventions:

DRUG: BIS-001ER

ClinicalTrials.gov

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Brief Summary: Background: \- The blood-brain barrier separates the brain from the rest of the body. Epilepsy is a neurological disease that causes seizures. It can affect this barrier. Researchers think a contrast agent called mangafodipir might be better able to show areas of the brain that epilepsy affects. Objective: \- To see if mangafodipir is well tolerated and safe. To see if it can show, on an MRI, areas of the brain that epilepsy affects. Eligibility: * People ages 18-60 who: * Have epilepsy not controlled by drugs * Prior or concurrent enrollment in 18-N-0066 is required Design: * Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Participants will have up to 6 visits in 1-3 months. Those with epilepsy will have an inpatient stay lasting 2-10 days. Visits may include: * Video-EEG monitoring for participants with epilepsy * An IV catheter put in place: a needle guides a thin plastic tube into an arm vein. * Getting mangafodipir through the IV. * 5 MRI scans over a 10-day period: a magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides into a metal cylinder. They are in the cylinder for 45-90 minutes, lying still for up to 10 minutes at a time. The scanner makes loud knocking sounds. Participants will get earplugs. * A final MRI at least 2 weeks after receiving mangafodipir. Gadolinium is given through an IV catheter....

Recruiting

Start Date:
2024-11-19

Close Date:
2026-07-01

Interventions:

DRUG: Mangafodipir

Recruiting

Start Date:
2024-11-19

Close Date:
2026-07-01

Interventions:

DRUG: Mangafodipir

ClinicalTrials.gov

IF-MCT 16:8: Investigating the Influence of Intermittent Fasting With and Without MCTs in Patients With Drug-resistant Epilepsy

Brief Summary: The objective of the prospective monocentric pilot trial is to investigate the influence of intermittent fasting with or without a once-daily intake with medium chain triglycerides (MCTs) on the frequency of seizures in patients with therapy-refractory epilepsy. The effects of 12 weeks intermittent fasting according to the 16:8 method (IF 16:8) are compared to 12 weeks intermittent fasting with additional intake of exogenous MCTs (IF MCT 16:8) in a within-subject-crossover-design in 28 patients with drug-resistant epilepsy.

Recruiting

Start Date:
2023-07-25

Close Date:
2025-12-31

Interventions:

OTHER: IF 16:8 as active comparator vs. IF MCT 16:8 as experimental arm

Recruiting

Start Date:
2023-07-25

Close Date:
2025-12-31

Interventions:

OTHER: IF 16:8 as active comparator vs. IF MCT 16:8 as experimental arm

ClinicalTrials.gov

SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures

Brief Summary: This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.

Recruiting

Start Date:
2025-07-30

Close Date:
2027-12-31

Interventions:

DRUG: SPN-817

Recruiting

Start Date:
2025-07-30

Close Date:
2027-12-31

Interventions:

DRUG: SPN-817

ClinicalTrials.gov

Self-management Intervention for Reducing Epilepsy Burden Among Ugandans With Epilepsy.

Brief Summary: The goal of this clinical trial is to assess the efficacy of self management intervention for reducing epilepsy burden among Ugandans with epilepsy (SMART- U) vs. enhanced treatment as usual (eTAU) via an RCT in adults with epilepsy. The main question\[s\] it aims to answer are: * What is the efficacy of SMART - Uganda (SMART-U) versus enhanced treatment as usual (eTAU) among PWE? * How does short message service (SMS) delivered by mobile phone text validate self-reported seizure occurrence? Participants will be randomly (1:1 basis) assigned to receive either SMART-U (N=94) or eTAU (N=94) using block randomization. SMART-U will consist of 2 main components: a 12-week "intensive" group format stage and a 12-week remotely accessed telephone follow-up stage. Individuals randomized to eTAU will continue in their usual care supplemented by written materials on epilepsy in their preferred language and tailored to the reading level of most patients at the clinic. If there is a comparison group: The investigators will compare the mean change in seizure frequency and quality of life from baseline and 24 weeks of follow up.

Recruiting

Start Date:
2025-01-06

Close Date:
2028-07-31

Interventions:

BEHAVIORAL: Self-MAnagement intervention for Reducing The epilepsy burden among Ugandans

Recruiting

Start Date:
2025-01-06

Close Date:
2028-07-31

Interventions:

BEHAVIORAL: Self-MAnagement intervention for Reducing The epilepsy burden among Ugandans

ClinicalTrials.gov

Assessing Functional Outcomes and User Experience of the Lexie B3 Pro Powered by Bose Over-the-counter Self-Fitting Hearing Aid

Brief Summary: Hearing loss significantly impacts quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a well-established intervention, yet barriers such as access and affordability limit their adoption, even in countries with developed audiological services . Despite their proven benefits, many individuals who could benefit from hearing aids do not obtain them. Traditionally, hearing aids required professional consultations, which created access challenges. In 2022, the U.S. FDA approved over-the-counter (OTC) hearing aids, including self-fitting devices, to improve accessibility. Recent clinical trials suggest that OTC hearing aids can provide similar benefits to professionally fitted ones in speech recognition and self-reported outcomes. One critique of past studies is that they often compare OTC hearing aids to audiologist-fitted devices using the same hardware, with differences primarily in programming methods. While much research has focused on fitting methods, this study aims to evaluate a new OTC hearing aid with its proprietary fitting algorithm against a marketed competitor. This randomized controlled trial (RCT) forms part of a larger validation study that follows a phased approach. Phase 1 validates an in-situ hearing test against a standard audiometer and Phase 2 assesses user experience. This RCT (Phase 3) will compare two OTC devices-the Lexie B3 Pro and a competitor already on the market-to evaluate self-reported benefit, user experience, and satisfaction. The hypothesis is that both devices provide comparable outcomes.

Not yet recruiting

Start Date:
2025-07-01

Close Date:
2025-08-31

Interventions:

DEVICE: Over the counter hearing aid (Lexie)
DEVICE: Comparator over the counter hearing aid

Not yet recruiting

Start Date:
2025-07-01

Close Date:
2025-08-31

Interventions:

DEVICE: Over the counter hearing aid (Lexie)
DEVICE: Comparator over the counter hearing aid

ClinicalTrials.gov

Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain

Brief Summary: Aim of the study is to better characterize the clinical profile of adjunctive cenobamate by collecting data from the current standard clinical practice in France, Germany, and Spain, to describe the real-world clinical response among adult patients affected by focal epilepsy not adequately controlled despite a history of 2 or 3 ASMs before starting treatment with cenobamate (including previous and concomitant ASMs).

Recruiting

Start Date:
2024-12-19

Close Date:
2027-03

Interventions:

DRUG: Cenobamate

Recruiting

Start Date:
2024-12-19

Close Date:
2027-03

Interventions:

DRUG: Cenobamate

ClinicalTrials.gov

Modulating Movement Intention Via Cortical Stimulation

Brief Summary: The purpose of this protocol is to learn about movement intention and volition. To improve such knowledge, investigators will conduct sub-studies using multiple non-invasive methodologies. These results could provide preliminary data for subsequent studies evaluating local and global efficacy of plasticity-inducing treatments for PMD symptoms.

Recruiting

Start Date:
2017-07-20

Close Date:
2027-05

Interventions:

DEVICE: Sham TMS3 stimulation
DEVICE: rTMS of left or right angular gyrus (AG) or frontal cortex (FC)
DEVICE: Anodal tDCS of left or right AG or FC

Recruiting

Start Date:
2017-07-20

Close Date:
2027-05

Interventions:

DEVICE: Sham TMS3 stimulation
DEVICE: rTMS of left or right angular gyrus (AG) or frontal cortex (FC)
DEVICE: Anodal tDCS of left or right AG or FC

ClinicalTrials.gov

RNS NAUTILUS Study

RNS System Pivotal Study of Responsive Bilateral Thalamic Stimulation for Idiopathic Generalized Seizures (NAUTILUS) Study

Brief Summary: To demonstrate that the RNS System for thalamic stimulation is safe and effective as an adjunctive therapy for the reduction of primary generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy.

Contact Information: For more info email: medaffairs@neuropace.com

Active, not recruiting

Start Date:
2022-08-09

Close Date:
2026-03

Interventions:

DEVICE: Responsive stimulation
DEVICE: Sham stimulation

Active, not recruiting

Start Date:
2022-08-09

Close Date:
2026-03

Interventions:

DEVICE: Responsive stimulation
DEVICE: Sham stimulation

Study Website ClinicalTrials.gov

Thalamus Seizure Detection With a Deep Brain Stimulator System

Brief Summary: The purpose of this study is to determine the feasibility of chronic ambulatory thalamus seizure detection. The sensitivity, specificity, and false alarm rate of thalamus seizure detection will be calculated using recordings from a deep brain stimulation system, assessed relative to concurrent gold-standard video-EEG monitoring collected in the in-patient setting (epilepsy monitoring unit), in 5 patients with drug resistant epilepsy.

Recruiting

Start Date:
2026-01-01

Close Date:
2027-05

Interventions:

DEVICE: Phase 1-Validation of thalamus seizure detection with concurrent video EEG monitoring
DEVICE: Phase 2-DBS Stimulation with Medtronic Percept DBS device-Out Patient

Recruiting

Start Date:
2026-01-01

Close Date:
2027-05

Interventions:

DEVICE: Phase 1-Validation of thalamus seizure detection with concurrent video EEG monitoring
DEVICE: Phase 2-DBS Stimulation with Medtronic Percept DBS device-Out Patient

ClinicalTrials.gov

Risk Factors for Sudden Unexplained Death in Epilepsy

Brief Summary: The main purpose of this study is to develop a North American registry for SUDEP cases; requesting family members of epilepsy patients who died suddenly of unclear causes (SUDEP) to contact the study team. The family members who decide to participate in the study will be asked to complete a brief telephone interview about their loved one's epilepsy and seizure history and the circumstances of his or her death. If the death has occurred within the past 24 hours, and the family is willing to consider donating tissue to the study, the subject will be transferred to the Autism Tissue Program, and the remainder of the phone interview will be conducted at a later time. In addition to the phone interview, the family will be asked to provide access to the deceased's medical records. Any costs involved in obtaining medical records will be covered by the study, and all medical information will remain completely confidential.

Recruiting

Start Date:
2011-06

Close Date:
2026-09

Recruiting

Start Date:
2011-06

Close Date:
2026-09

ClinicalTrials.gov

The Incidence And Risk Factors Of Recurrent Febrile Seizures And Epilepsy Following Febrile Seizures

Brief Summary: The goal of this observational study is to learn about the recurrence and development of epilepsy in children hospitalized with their first febrile seizures. The main questions it aims to answer are: * What is the risk of recurrence after the first febrile seizure and what are the risk factors for recurrent febrile seizures in Vietnamese children? * What is the risk of developing epilepsy later in life and what are the risk factors for developing epilepsy in Vietnamese children who have had febrile seizures?

Recruiting

Start Date:
2023-03-15

Close Date:
2025-09-15

Recruiting

Start Date:
2023-03-15

Close Date:
2025-09-15

ClinicalTrials.gov

Transnasal Induction of Normothermia for Neurogenic Fever

Brief Summary: The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.

Recruiting

Start Date:
2023-11-21

Close Date:
2025-10

Interventions:

DEVICE: Transnasal Thermal Regulating Device

Recruiting

Start Date:
2023-11-21

Close Date:
2025-10

Interventions:

DEVICE: Transnasal Thermal Regulating Device

ClinicalTrials.gov

A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures

Brief Summary: This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy.

Not yet recruiting

Start Date:
2025-11-03

Close Date:
2028-02-03

Interventions:

DRUG: RAP-219

Not yet recruiting

Start Date:
2025-11-03

Close Date:
2028-02-03

Interventions:

DRUG: RAP-219

ClinicalTrials.gov

Levetiracetam Versus Phenobarbital in Benzodiazepines Unresponsive Paediatric Prolonged Seizures

Brief Summary: Convulsive prolonged seizures in children are the most common life-threatening neurological emergencies. The aim of active management of seizure control is to prevent irreversible neuronal damage as early as possible. Although there is evidence of the use of benzodiazepines as the initial management for prolonged seizures, up to a third of patients do not respond to benzodiazepines. Many trials study the rate of seizures control among various second-line antiseizure medications (ASMs) in benzodiazepines unresponsive convulsive prolonged seizures. However, there is still few recommendations for paediatric population which drug is the most effective to control seizures rapidly and there is also a limited data on which drug has less adverse effects and is well tolerated. Currently, injection phenobarbital or levetiracetam is used as second-line antiseizure medication based on expert opinion in many centres globally including Yangon Children's Hospital. From this study, it is expected to identify the safer and more effective second-line treatment for prolonged seizures in children and be helpful in considering the alternative choice of appropriate medications in the management of prolonged seizures to include in the local guideline. A hospital-based randomized comparative study will be conducted at Yangon Children's Hospital. All children with benzodiazepines unresponsive prolonged seizures will be eligible for this study with the minimum sample size of 180 (90:90). Consecutive sample collection by block randomization will be done throughout the study period. The informed consent will be taken after explanation of nature, purposes, procedure, durations, benefits and risks. This study will be started with the approval of Academic Board of Study and Research and Ethics Committee, University of Medicine 1, Yangon. By this study, clinical response of intravenous levetiracetam versus intravenous phenobarbital in children with benzodiazepines unresponsive prolonged seizures will be evaluated. Aim of this study is to study the clinical response of intravenous levetiracetam versus intravenous phenobarbital in children with prolonged seizures unresponsive to benzodiazepines. Findings will support the choice of the safer and more effective second-line treatment for prolonged seizures in Myanmar children. After case selection according to inclusion criteria and getting informed consent, computerized block randomization will be done. Total 9 blocks will be generated with group A and group B. Each child will be assigned as group A or group B according to randomization. All patients will be received supportive care according to treatment guideline of the ward. Group A patients will be treated with intravenous levetiracetam 40 mg/kg (maximum of 3000 mg) over 15 minutes. Group B patients will be treated with intravenous phenobarbital 20 mg/kg (maximum of 1000 mg) over 20 minutes. Injection levetiracetam will be diluted with 5% dextrose water to a concentration of 50 mg/ml. Injection phenobarbital will be diluted to become 20 ml with 5% dextrose water. All participants will also be monitored for oxygen saturation, respiratory rate and pattern, pulse rate, pulse volume, and blood pressure to detect treatment-related adverse effects. Monitoring will be conducted before, during, and 5 minutes after the assigned drug infusion, then hourly for 4 hours, every 2 hours for the following 4 hours, and every 4 hours thereafter. The primary outcome of the study will be the clinical cessation of the seizure at five minutes after the completion of the infusion of intravenous levetiracetam or phenobarbital. The secondary outcome of the study will be the recurrence of seizure within 12 hours after the commencement of the study medications, need of other medications for active seizure control within 12 hours after the commencement of the study medications, need for rapid sequence induction (RSI) with thiopentone for on-going seizure management after administration of study medications. These secondary outcomes will be assessed in treatment-responsive groups. Treatment related adverse effects will also be assessed within five minutes of drug infusion in both treatment groups and within 12 hours in treatment-responsive groups. Data analysis will be done to compare the clinical response. If the patient's seizure has stopped five minutes after completing the infusion of the assigned medication, a maintenance dose of either levetiracetam or phenobarbital, whichever was previously used, will be administered intravenously. If the patient is still experiencing seizure five minutes after completing the infusion of the assigned medication, the patient will be treated with an alternative second-line ASM. If the patient experiences serious treatment-related adverse effects within five minutes of the levetiracetam or phenobarbital infusion, the drug infusion will be stopped.

Recruiting

Start Date:
2025-07-22

Close Date:
2026-06-30

Interventions:

DRUG: Levetiracetam IV
DRUG: Phenobarbital

Recruiting

Start Date:
2025-07-22

Close Date:
2026-06-30

Interventions:

DRUG: Levetiracetam IV
DRUG: Phenobarbital

ClinicalTrials.gov

Prophylactic Anti-Seizure Medication vs No Anti-Seizure Medication for Patients With Primary Motor Cortex Brain Metastases

Brief Summary: This is a randomized trial for patients with brain metastases in the primary motor cortex who have not had seizures to receive either the prophylactic anti-seizure medication levetiracetam (also known by its trade name Keppra) or proceed with standard of care management, which does not currently include prophylactic levetiracetam. Patients who enroll to this trial will be randomized to receive prophylactic levetiracetam or not receive prophylactic levetiracetam.

Not yet recruiting

Start Date:
2025-09

Close Date:
2030-02

Interventions:

DRUG: Levetiracetam (Keppra)

Not yet recruiting

Start Date:
2025-09

Close Date:
2030-02

Interventions:

DRUG: Levetiracetam (Keppra)

ClinicalTrials.gov

The Efficacy and Safety of Levetiracetam Versus Fosphenytoin in Convulsive Status Epilepticus

Brief Summary: Status epilepticus (SE) is an emergency, life-threatening medical condition that may cause irreversible cerebral damage. Therefore, the rapid and secure cessation of seizures and resuscitation is crucial. Potent gamma-aminobutyric acid agonists, including benzodiazepines, are recommended as first-line treatments. For the complete cessation of SE and prevention of recurrence, long-acting antiepileptic drugs (e.g.- FPHT) are also required as second-line treatments along with short-acting benzodiazepines. Intravenous fosphenytoin (FPHT) is associated with fewer adverse events such as life-threatening arrhythmia, cardiac arrest, hypotension, and allergic reactions. Levetiracetam (LEV), is considered to be effective for SE with less serious adverse events including dizziness, somnolence, headache, and transient agitation, but there have been no reports of arrhythmias, hypotension, Stevens-Johnson syndrome, or hepatotoxicity. Preceding studies show that levetiracetam is similarly effective and associated with fewer adverse effects than those of fosphenytoin. Few trials have compared the effectiveness and safety of levetiracetam (LEV) and fosphenytoin (FHP) for status epilepticus worldwide. Moreover, genetic variation is likely to play a crucial role in the development of adverse drug reactions (ADRs) including drug resistance. By far, no study has yet been conducted addressing the issue of efficacy and safety between levetiracetam (LEV) and fosphenytoin (FHP) in status epilepticus in the context of the Bangladeshi population. A comparative study of the efficacy and safety of levetiracetam (LEV) and fosphenytoin (FHP) will be expected to give more confidence for the use of the drug. Considering this the study aims to assess the safety and efficacy of levetiracetam (LEV) and fosphenytoin (FHP) in status epilepticus. This study finding has an implication in the treatment protocol which will be beneficial for the patients and physicians as well. Furthermore, it will give input to the policymaker for developing new guidelines regarding status epilepticus management and also encourage future research.

Enrolling by invitation

Start Date:
2023-05-15

Close Date:
2024-10

Interventions:

DRUG: Levetiracetam Injection
DRUG: Fosphenytoin Injection

Enrolling by invitation

Start Date:
2023-05-15

Close Date:
2024-10

Interventions:

DRUG: Levetiracetam Injection
DRUG: Fosphenytoin Injection

ClinicalTrials.gov

A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures

Brief Summary: The purpose of this study is to assess the feasibility of conducting a future fully powered multi-site efficacy Randomized Controlled Trial (RCT) comparing two treatments for pediatric functional seizures (FS). In this study, 11-18-year-olds diagnosed with FS will be randomized to 12 sessions of Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) at 3 sites: University of Alabama at Birmingham, Yale School of Medicine/Yale New Haven Children's Hospital and Baylor College of Medicine/Texas Children's Hospital. Feasibility of recruitment will be measured by the percentage of planned participant enrollment target obtained at each site and overall during the 18 months of planned enrollment. Acceptability will be assessed using the Acceptability Questionnaire. Participant retention will be measured by the percent of enrolled participants that complete the 2-month follow-up visit at each site and overall. For treatment fidelity assessment, 20% of each therapist's sessions will be randomly chosen and assessed for fidelity. Patient adherence will be measured in two ways: 1) the percent of ReACT or CATCH-IT sessions completed at each site and overall and 2) for ReACT, the percent of times participants report using the treatment plan during FS episodes (measured by FS diary) and for CATCH-IT, the number of times parents and children spend using CATCH-IT each week (measured by the CATCH-IT platform). These data will be used to support a future fully-powered multi-site RCT assessing the efficacy of ReACT for pediatric FS.

Recruiting

Start Date:
2024-03-18

Close Date:
2027-08

Interventions:

BEHAVIORAL: ReACT
BEHAVIORAL: CATCH-IT

Recruiting

Start Date:
2024-03-18

Close Date:
2027-08

Interventions:

BEHAVIORAL: ReACT
BEHAVIORAL: CATCH-IT

ClinicalTrials.gov

FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

Brief Summary: This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of adverse events) and effective (seizure frequency). NRTX-1001 comprises human interneurons that secrete a neurotransmitter, gamma-aminobutyric acid (GABA).

Recruiting

Start Date:
2022-06-16

Close Date:
2042-02

Interventions:

BIOLOGICAL: NRTX-1001
BIOLOGICAL: NRTX-1001
PROCEDURE: Sham Comparator

Recruiting

Start Date:
2022-06-16

Close Date:
2042-02

Interventions:

BIOLOGICAL: NRTX-1001
BIOLOGICAL: NRTX-1001
PROCEDURE: Sham Comparator

ClinicalTrials.gov

Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules Compared to the Original Formulation of NPT 2042

Brief Summary: A Single-center, Open-label, Single-dose, Three-period, Fixed Sequence Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules

Recruiting

Start Date:
2025-09-29

Close Date:
2025-11-15

Interventions:

DRUG: NPT 2042 (Reference formula/Formulation 1)
DRUG: NPT 2042 (Test formula/Formulation 2)
DRUG: NPT 2042 (Test formula/Formulation 2)

Recruiting

Start Date:
2025-09-29

Close Date:
2025-11-15

Interventions:

DRUG: NPT 2042 (Reference formula/Formulation 1)
DRUG: NPT 2042 (Test formula/Formulation 2)
DRUG: NPT 2042 (Test formula/Formulation 2)

ClinicalTrials.gov

Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms

Brief Summary: Main objective: Compare speech recognition in noise with tonotopic setting (FS4T) and with tonotopic fitting modified by evolutionary algorithm (EAFS4T) in adult patients implanted for 6 months or more with a MED-EL cochlear implant with FS4T. Secondary objectives: Comparison of FS4T and EAFS4T settings * for speech recognition in quiet * for subjective auditory spatial perception * for subjective auditory and musical perception

Recruiting

Start Date:
2025-01-15

Close Date:
2028-01-15

Interventions:

OTHER: EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting

Recruiting

Start Date:
2025-01-15

Close Date:
2028-01-15

Interventions:

OTHER: EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting

ClinicalTrials.gov

An Open-label Study of XEN1101 in Epilepsy

Brief Summary: This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 3 years.

Enrolling by invitation

Start Date:
2023-04-25

Close Date:
2028-09

Interventions:

DRUG: XEN1101

Enrolling by invitation

Start Date:
2023-04-25

Close Date:
2028-09

Interventions:

DRUG: XEN1101

ClinicalTrials.gov

Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

Brief Summary: This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.

Recruiting

Start Date:
2021-10-25

Close Date:
2026-07

Interventions:

DEVICE: STARSTIM device
DEVICE: Sham Device

Recruiting

Start Date:
2021-10-25

Close Date:
2026-07

Interventions:

DEVICE: STARSTIM device
DEVICE: Sham Device

ClinicalTrials.gov

Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma

Brief Summary: This study investigates how seizures can vary over time with changes in low grade gliomas and its treatments. This study may help doctors find symptoms or triggers of seizures earlier than normal, and ultimately earlier care or treatment for seizures.

Active, not recruiting

Start Date:
2020-07-08

Close Date:
2025-12-30

Interventions:

OTHER: Survey Administration

Active, not recruiting

Start Date:
2020-07-08

Close Date:
2025-12-30

Interventions:

OTHER: Survey Administration

ClinicalTrials.gov

Evaluation of Tibial Nerve Selective Neurotomy Compared to Botulinum Toxin Injections for Spastic Foot Treatment in Post-stroke Patients According to a Goal-centered Approach

Brief Summary: In France, more than 110.000 patients are hospitalized for stroke per year. It is the leading cause of sudden disabilities in adults. Incidence of spastic foot is evaluated at 1 year post stroke from 18% to 56% of hemiplegic patients. Spasticity, defined as an increase in the velocity-dependent response to muscle stretch measured at rest, is part of the upper motor neuron syndrome and is characterized by an increase in tonic stretch reflex. It has been proposed that upper motor neuro syndrome may induce not only spasticity but also other types of muscles overactivity such as spastic dystonia, co-contraction and clonus. In hemiplegic patients, lower limb spasticity within the posterior part of the leg frequently results in equino-varus foot and toes claw. These abnormal postures in hemiplegics may affect activities of daily living such as shoes fitting, balance, ambulation-walking, comfort (pain) and may become irreducible (tendon shortening) if not treated. The purpose of this study is to compare the interest of each treatment (BoNT-A versus STN) in order to specify both techniques indications and up-date current guidelines of lower-limb spasticity for hemiplegic patients. This study aims to confirm a greater reduction of calf muscles spasticity after STN as compared to BoNT-A, as observed in the only published monocentric randomized controlled trial. Our study originality is to perform a multi-center RCT with a pre-established sample size. This study will also quantify progress towards personal goals using the goal attainment scaling (GAS) and will assess other components related to the consequences of carve muscle spasticity on balance, ambulation, self-care and quality of life.

Recruiting

Start Date:
2024-01-02

Close Date:
2027-03-02

Interventions:

PROCEDURE: Tibial nerve selective neurotomy
DRUG: Botulinum toxin injection

Recruiting

Start Date:
2024-01-02

Close Date:
2027-03-02

Interventions:

PROCEDURE: Tibial nerve selective neurotomy
DRUG: Botulinum toxin injection

ClinicalTrials.gov

A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)

Brief Summary: This (DEEp SEA Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. The total duration of the study will be approximately 24 months.

Recruiting

Start Date:
2024-09-25

Close Date:
2026-10-02

Interventions:

DRUG: LP352
DRUG: Placebo

Recruiting

Start Date:
2024-09-25

Close Date:
2026-10-02

Interventions:

DRUG: LP352
DRUG: Placebo

ClinicalTrials.gov

Neuroliten MVP System Clinical Observation Study

Brief Summary: This is an observational study for data collection from subjects diagnosed with Epilepsy/intractable seizures. The Neuroliten MVP System will not be used for patient management or treatment decisions.

Active, not recruiting

Start Date:
2022-10-31

Close Date:
2024-12

Interventions:

DEVICE: Neuroliten MVP system

Active, not recruiting

Start Date:
2022-10-31

Close Date:
2024-12

Interventions:

DEVICE: Neuroliten MVP system

ClinicalTrials.gov

A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)

Brief Summary: This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months.

Enrolling by invitation

Start Date:
2025-02-12

Close Date:
2027-12

Interventions:

DRUG: LP352

Enrolling by invitation

Start Date:
2025-02-12

Close Date:
2027-12

Interventions:

DRUG: LP352

ClinicalTrials.gov

Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure

Brief Summary: The goal of this study is to compare levetiracetam to magnesium sulfate for the prevention of eclamptic seizures in pregnant persons with severe preeclampsia that are 32 or more weeks pregnant. This is an equivalence study so our primary goal is to see no difference in the incidence of seizure in the two groups. Since side effects can be a significant problem with magnesium sulfate and these patients are at significant risk of life threatening complications, we also plan to evaluate several secondary outcomes in the mothers and the babies, including: severe allergic reaction, magnesium toxicity, ICU admission, hospital readmission, transfusion for any reason, pulmonary edema, cardiomyopathy, Posterior Reversible Encephalopathy Syndrome, eclamptic seizure, loss of vision, stroke, renal injury requiring dialysis, cardiac arrest, maternal death, unexpected stillbirth or neonatal death, NICU admission, Apgars and length of neonatal respiratory support.

Not yet recruiting

Start Date:
2026-01-01

Close Date:
2034-07

Interventions:

DRUG: Levetiracetam
DRUG: magnesium sulfate

Not yet recruiting

Start Date:
2026-01-01

Close Date:
2034-07

Interventions:

DRUG: Levetiracetam
DRUG: magnesium sulfate

ClinicalTrials.gov

Genetic Markers of Cardiovascular Disease in Epilepsy

Brief Summary: Epilepsy is a common condition which affects over 3 million people in the US. Patients with uncontrolled epilepsy have a lifetime risk of sudden unexpected death (SUDEP) of 35%, which is greatest in those under 40 years of age. The exact mechanisms and causes are not understood but can be due to underlying conditions which affect the heart and brain, which may lead to dangerous heart rhythms and death. Some of these conditions which affect heart and brain have an identifiable genetic cause. This study aims to identify known genetic causes of heart rhythm and sudden death related disorders in patients with epilepsy.

Recruiting

Start Date:
2016-05

Close Date:
2031-12

Recruiting

Start Date:
2016-05

Close Date:
2031-12

ClinicalTrials.gov

Cenobamate in the Intensive Care Unit

Brief Summary: The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH. Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome.

Not yet recruiting

Start Date:
2024-04

Close Date:
2025-06

Interventions:

DRUG: Cenobamate

Not yet recruiting

Start Date:
2024-04

Close Date:
2025-06

Interventions:

DRUG: Cenobamate

ClinicalTrials.gov

Etiology and Treatment of Neonatal Seizure

Brief Summary: Genetic diagnosis for neonates suffering from epilepsy has important implications for treatment, prognosis, and development of precision medicine strategies. Investigator performed exome sequencing (ES) or targeted sequencing on neonates with seizure onset within the first month of life. Investigator subgrouped our patients based on the onset age of seizure into neonatal and before 1 year (1-12 months), to compare the clinical and genetic features and treatment strategies.

Recruiting

Start Date:
2016-08-08

Close Date:
2026-12-30

Recruiting

Start Date:
2016-08-08

Close Date:
2026-12-30

ClinicalTrials.gov

Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy

Brief Summary: The goal of this multi-site clinical trial is to determine the effectiveness of two components of a web-based intervention (Epilepsy Journey) to improve executive functioning in adolescents with epilepsy. The two components include web-based modules and problem-solving telehealth sessions with a therapist focused on executive functioning. This trial aims to answer the following questions: 1. Which components of Epilepsy Journey (web-based modules or telehealth sessions with a therapist) are essential for improving executive functioning in adolescents with epilepsy? 2. Which components of Epilepsy Journey (web-based modules or telehealth sessions with a therapist) are essential for improving quality of life in adolescents with epilepsy? Participants will be randomly assigned to one of four groups: 1) Epilepsy Journey web-based modules and telehealth sessions, 2) Epilepsy Journey web-based modules only, 3) telehealth sessions with a therapist only, or 4) treatment as usual. Participants will: * Independently review Epilepsy Journey web-based modules focused on executive functioning skills (\~15-30 minutes) and/or have weekly telehealth sessions (\~30-45 minutes) with a therapist for 14 weeks. * Complete measures of executive functioning (parent and teen-report) and quality of life (teen-report) at the start of the study, 14-, 26-, and 66- weeks after randomization. The NIH toolbox will be completed at the start of the study and 26-weeks after randomization. Additional measures will also be collected.

Recruiting

Start Date:
2024-11-11

Close Date:
2029-01-31

Interventions:

BEHAVIORAL: Epilepsy Journey web-based modules
BEHAVIORAL: Telehealth with a therapist

Recruiting

Start Date:
2024-11-11

Close Date:
2029-01-31

Interventions:

BEHAVIORAL: Epilepsy Journey web-based modules
BEHAVIORAL: Telehealth with a therapist

ClinicalTrials.gov

Lacosamide Intravenous Injection for Emergency Termination of Status Epilepticus

Brief Summary: Status epilepticus (SE) is an acute and critical form of neurological and systemic diseases involving multiple clinical disciplines, with an annual incidence of (20-73) per 100,000 people and a clinical case fatality rate of 20%. Although there are many causes of SE, the primary goal of treatment is to terminate the seizures quickly, and timely and standardized treatment can reduce mortality and improve prognosis. The prognosis is closely related to the duration of the episode, and the longer the episode, the worse the prognosis. If seizures of convulsive status epilepticus persist for more than 10 minutes and are not provided with optimal therapeutic intervention, serious adverse outcomes and even death are likely to occur. How to effectively terminate status epilepticus and actively find effective, reliable and safe treatment options is a key research problem at present. Due to critical illness, limited treatment options, and poor prognosis, new treatments are urgently needed to terminate persistent epileptic activity. Lacosamide (LCM) is a third-generation new antiepileptic drug, which was approved in 2008 for the additive treatment of patients aged 16 years and older with focal seizures, with or without generalized seizures. In 2017, it was extended to patients over 4 years of age. Lacosamide is an anticonvulsant drug with a new dual mechanism of action: first, lacosamide antagonizes the glycine site of N-methyl-D-aspartate (NMDA) receptor; Second, lacosamide selectively acts on the slow inactivation of sodium channels and prolongs the inactivation time of sodium channels, which can more effectively reduce sodium influx and reduce the excitability of neurons, so as to achieve the purpose of treating epilepsy. Lacosamide exhibits linear pharmacokinetics, high oral bioavailability, protein binding of \< 15%, rapid and almost complete absorption in a single oral dose, and maximum plasma concentrations within 1 to 4 hours. A number of randomized controlled clinical studies and real-world studies abroad have shown that lacosamide can significantly improve the effective rate and seizure-free rate of epilepsy control, and it is well tolerated and has fewer adverse reactions. The 2022 Chinese Expert Consensus on the Diagnosis and Treatment of Post-stroke Epilepsy recommended lacosamide injection as a first-line drug for non-convulsive status epilepticus after stroke, and the Chinese Expert Consensus on the Diagnosis and Treatment of Status Epilepticus in Children (2022) recommended that lacosamide be considered as an additive treatment for refractory convulsive status epilepticus in children \> 60 minutes . There is a lack of clinical research data on the efficacy and safety of intravenous bolus lacosamide for status epilepticus, including convulsive status epilepticus and non-convulsive epilepticus.

Not yet recruiting

Start Date:
2025-06-06

Close Date:
2027-10-30

Interventions:

DRUG: Lacosamide (LCM)

Not yet recruiting

Start Date:
2025-06-06

Close Date:
2027-10-30

Interventions:

DRUG: Lacosamide (LCM)

ClinicalTrials.gov

SeizEAR Safety Study

Brief Summary: Determine the safety and feasibility of an in-ear device to measure seizures or suspected seizures compared to the standard scalp-based electroencephalogram (EEG). The study team anticipates enrolling five healthy participants through meeting announcements and a research email list serv in the Neurology Dept. Based on the appropriate positive initial test of healthy individuals, test the in-ear device on 10 participants with seizures or suspected seizures scheduled for a clinical scalp EEG test.

Enrolling by invitation

Start Date:
2025-05-08

Close Date:
2025-10-31

Interventions:

DEVICE: SeizEAR

Enrolling by invitation

Start Date:
2025-05-08

Close Date:
2025-10-31

Interventions:

DEVICE: SeizEAR

ClinicalTrials.gov

A Retrospective Study to Validate BioEP as an Assessment Aid for Seizure Susceptibility

Brief Summary: The goal of this retrospective study is to validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known epilepsy diagnosis. The main objectives of the study are: * To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis * To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis (thus adding economic value), by reducing time to final diagnosis and/or the number of clinical appointments needed.

Not yet recruiting

Start Date:
2025-01-01

Close Date:
2025-03-01

Not yet recruiting

Start Date:
2025-01-01

Close Date:
2025-03-01

ClinicalTrials.gov

Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.

Brief Summary: The goal of this clinical trial is to test Epitel's™ Remote EEG Monitoring System's (REMI™) ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for extended periods (14 - 28 days) in patients presenting with questionable seizure characterization. The main questions it aims to answer are: • Can more seizure events be recorded in fourteen (14) days than can be recorded in three (3) days? • Do treating clinicians find clinical value in extended fourteen (14) - twenty-eight (28) days of EEG? Participants will wear a portable EEG device (REMI) for fourteen (14) to twenty-eight (28) days in their home/community setting.

Recruiting

Start Date:
2023-10-13

Close Date:
2025-06-01

Interventions:

DEVICE: Epitel's™ Remote EEG Monitoring System's (REMI™)

Recruiting

Start Date:
2023-10-13

Close Date:
2025-06-01

Interventions:

DEVICE: Epitel's™ Remote EEG Monitoring System's (REMI™)

ClinicalTrials.gov

Application of tDCS Stimulation in Controlling Refractory Status Epilepticus

Brief Summary: The purpose of the study is to assess the efficacy and safety of targeting tDCS stimulation for treatment of Refractory status epilepticus

Recruiting

Start Date:
2024-04-01

Close Date:
2025-03-31

Interventions:

DEVICE: tDCS stimulation
DEVICE: TDCS sham-stimulation

Recruiting

Start Date:
2024-04-01

Close Date:
2025-03-31

Interventions:

DEVICE: tDCS stimulation
DEVICE: TDCS sham-stimulation

ClinicalTrials.gov

Prospective Evaluation of Probabilistic Predictions of Epileptic Seizure Risk Using the EPIDAY Tool

Brief Summary: Studies suggest the existence of a pre-critical state preceding the onset of an epileptic seizure. Identifying these states from self-reported prodromal symptoms, combined with machine learning algorithms, could help anticipate seizures.

Not yet recruiting

Start Date:
2025-10

Close Date:
2028-01

Interventions:

BEHAVIORAL: Seizure diary
BEHAVIORAL: Questionnaries

Not yet recruiting

Start Date:
2025-10

Close Date:
2028-01

Interventions:

BEHAVIORAL: Seizure diary
BEHAVIORAL: Questionnaries

ClinicalTrials.gov

Neural Autoantibody Prevalence in New-onset Focal Seizures of Unknown Etiology

Brief Summary: Seizure is one of the most common symptoms in autoimmune encephalitis with neuronal surface-mediated antibodies. Interestingly, some patients may exhibit new-onset seizures as the initial manifestation without fulminant sign of encephalitis, particularly in the early stage. It is essential to recognize these patients early and to perform antibody testing, as studies have reported early immunotherapy can improve their clinical outcomes. At the same time, it is important to limit the number of patients who require testing, for the sake of specificity and cost effectiveness. Thus, this prospective, multicenter study aims to identify neural antibodies in patients with focal seizures of unknown etiology, and to create a score to preselect patients requiring autoantibody testing.

Recruiting

Start Date:
2023-08-01

Close Date:
2030-12-31

Recruiting

Start Date:
2023-08-01

Close Date:
2030-12-31

ClinicalTrials.gov

OASIS: RetrOspective Analysis on EEGs for Identifying Seizure Susceptibility in paediatrIcs Using biomarkerS

Brief Summary: The goal of this retrospective study is to validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy. The main objectives are: Primary: To validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy. Secondary: To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis (thus adding economic value), by reducing time to final diagnosis and/or the number of clinical appointments needed

Not yet recruiting

Start Date:
2025-01-01

Close Date:
2026-01-01

Interventions:

DEVICE: BioEP

Not yet recruiting

Start Date:
2025-01-01

Close Date:
2026-01-01

Interventions:

DEVICE: BioEP

ClinicalTrials.gov

ADIE-FS - Aligning Dimensions of Interoceptive Experience in Patients With Functional Seizures

Brief Summary: Functional seizures are common and harmful. They look like epileptic seizures but are not caused by the excess electrical discharges in the brain that arise in epilepsy. Our understanding of the mechanisms that give rise to functional seizures is limited, and for this reason the development of novel treatments for functional seizures is also limited. Recent research by our and other groups has shown that interoception may play an important role in the development of functional seizures. Interoception refers to the process by which the nervous system senses, interprets and integrates information from inside the body. Research has shown that altered interoception is linked to functional seizures. We have shown that patients with functional seizures have a reduced ability to accurately identify signals from within their bodies, such as their heartbeats. The worse their ability, the greater their seizure severity and higher their levels of other unwanted symptoms. In separate research other groups have shown that interoceptive training, that is actively training an individual to better recognise signals from their body, can reduce levels of anxiety and the levels of unwanted symptoms. In this study we therefore plan to explore the feasibility of interoceptive training in patients with functional seizures.

Recruiting

Start Date:
2024-01-10

Close Date:
2024-05-01

Interventions:

BEHAVIORAL: Interoceptive training

Recruiting

Start Date:
2024-01-10

Close Date:
2024-05-01

Interventions:

BEHAVIORAL: Interoceptive training

ClinicalTrials.gov

Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs

Brief Summary: This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and alerting system for Veterans with seizures with upper extremity motor involvement, that are refractory to three or more antiepileptic drugs.

Not yet recruiting

Start Date:
2020-01

Close Date:
2026-01

Interventions:

DEVICE: SPEAC System

Not yet recruiting

Start Date:
2020-01

Close Date:
2026-01

Interventions:

DEVICE: SPEAC System

ClinicalTrials.gov

Cuirass Fitting Study - Time for Mounting and Ventilation

Brief Summary: Non-invasive biphasic cuirass ventilation (BCV) has recently been described for ENT surgery (ref 1-2). The clinical experience is however still sparse and further study is required. The purpose of the study is to descibe 1) mounting time and fitting of the cuirass shell on voluntary participants and 2) time to visible ventilation

Enrolling by invitation

Start Date:
2023-11-30

Close Date:
2023-11-30

Interventions:

DEVICE: Cuirass ventilation

Enrolling by invitation

Start Date:
2023-11-30

Close Date:
2023-11-30

Interventions:

DEVICE: Cuirass ventilation

ClinicalTrials.gov

An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303

Brief Summary: This is an extended access study for participants who have completed Rufinamide Study E2080-G000-303 to continue to have access to rufinamide until it becomes commercially available in Poland or until no participants remain in the EAP.

Available

Start Date:

Close Date:

Interventions:

DRUG: Rufinamide

Available

Start Date:

Close Date:

Interventions:

DRUG: Rufinamide

ClinicalTrials.gov

Development of a Seizure Detection Algorithm Based on Heart Rate and Movement Analysis

Brief Summary: Epilepsy is the 3rd neurological pathology after migraines and dementia syndromes with a high estimate of nearly 600,000 people affected in France. The disease is characterized by the repetition of epileptic seizures on the one hand, but also by the cognitive, behavioral, psychological and social consequences of this condition, especially when the epileptic disease is not stabilized. Epileptic patients feel a great deal of stress due to the unpredictability of the occurrence of seizures. Seizure detection is of great interest to bioinformatics researchers and to people with epilepsy and their caregivers. Recent advances in physiological sensor technologies and artificial intelligence have opened the possibility of developing systems capable of closely monitoring the frequency of epileptic seizures with a direct impact on therapeutic adaptations. This may eventually allow for seizure prediction and/or "seizure weather" (i.e., seizure forecasting) if there is a particular chronotype of seizure occurrence for a given individual. Currently, few devices have a sufficient level of evidence regarding their effectiveness to be recommended. Those that seem to be the most advanced are those that allow the identification of hypermotor seizures, including tonic-clonic generalized seizures and tonic-clonic secondary generalized focal seizures, mostly occurring at night. The latter represent only a small part of epileptic seizures. The objective of the present study is to build a real life database in order to develop a seizure detection algorithm. The recorded data will be heart rate via ECG and movement data via 9 variables measured on 3 axes x, y, z, with 3 sensors: accelerometer, gyroscope, magnetometer. These data will be collected using a connected patch available on the market (CE marking). At the same time, the patients will benefit from a long term video-EEG examination which will be annotated by the doctors and will be used as a gold standard for the identification of seizures in order to train the algorithm. This more complete base will be used to develop an algorithm previously developed from retrospective data.

Recruiting

Start Date:
2023-06-05

Close Date:
2025-06

Interventions:

OTHER: - EEG video recording or extension of an EEG video recording planned as part of the care - Wearing a connected heart rate and motion recording patch

Recruiting

Start Date:
2023-06-05

Close Date:
2025-06

Interventions:

OTHER: - EEG video recording or extension of an EEG video recording planned as part of the care - Wearing a connected heart rate and motion recording patch

ClinicalTrials.gov

Establishment of an Interdisciplinary Functional Neurological Disorder (FND) Treatment Program and Development of a Clinical Care Pathway for FND

Brief Summary: The purpose of this study is to help providers develop an interdisciplinary treatment pathway for functional neurological disorder (FND) at University of Alabama at Birmingham (UAB), and will involve psychiatry, speech therapy, physical therapy, and occupational therapy. The study will also help providers to evaluate the treatment pathway and publish results regarding the process and outcomes.

Recruiting

Start Date:
2025-07-18

Close Date:
2028-12-31

Recruiting

Start Date:
2025-07-18

Close Date:
2028-12-31

ClinicalTrials.gov

Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of iQ-007

Brief Summary: This is a randomized, double-blind, placebo-controlled study conducted in healthy adult volunteers to assess the safety, tolerability and pharmacokinetics of iQ-007. iQ-007 may be indicated for use in patients with Focal Seizures and Drug-resistant Epilepsy (DRE).

Recruiting

Start Date:
2025-04-08

Close Date:
2025-10-31

Interventions:

DRUG: iQ-007
DRUG: Placebo

Recruiting

Start Date:
2025-04-08

Close Date:
2025-10-31

Interventions:

DRUG: iQ-007
DRUG: Placebo

ClinicalTrials.gov

Oxygen Toxicity: Mechanisms in Humans

Brief Summary: The goal of this clinical trial is to learn about the mechanisms of oxygen toxicity in scuba divers. The main questions it aims to answer are: * How does the training of respiratory muscles affect oxygen toxicity? * How do environmental factors, such as sleep deprivation, the ingestion of commonly utilized medications, and chronic exposure to carbon dioxide, impact the risk of oxygen toxicity? * How does immersion in water affect the development of oxygen toxicity? Participants will be asked to do the following: * Undergo a basic screening exam composed of health history, vital signs, and some respiratory function tests * Train their respiratory muscles at regular intervals * Exercise on a cycle ergometer both in dry conditions and underwater/under pressure in the context of medication, sleep deprivation, or carbon dioxide exposure Researchers will compare the performance of each subject before and after the possible interventions described above to see if there are changes in exercise performance, respiratory function, cerebral blood flow, and levels of gene expression.

Recruiting

Start Date:
2023-11-28

Close Date:
2026-08-31

Interventions:

BEHAVIORAL: Sleep Deprivation
DRUG: Caffeine
DRUG: Methylphenidate
DRUG: Carbon Dioxide

Recruiting

Start Date:
2023-11-28

Close Date:
2026-08-31

Interventions:

BEHAVIORAL: Sleep Deprivation
DRUG: Caffeine
DRUG: Methylphenidate
DRUG: Carbon Dioxide

ClinicalTrials.gov

The Use of a US-measured Styloid Process of the Distal Radius EET Diameter for Prediction of ETT Size

Brief Summary: This study will aim to test the accuracy of the ultrasonography measurement of the epiphyseal diameter of the distal radius in the prediction of the size of the cuffed and uncuffed ETT that best fits in children (1-6 years old) in comparison with the traditional age-based formulas.

Recruiting

Start Date:
2024-01-10

Close Date:
2026-01-30

Interventions:

DEVICE: Cuffed endotracheal tube
DEVICE: UnCuffed ETT

Recruiting

Start Date:
2024-01-10

Close Date:
2026-01-30

Interventions:

DEVICE: Cuffed endotracheal tube
DEVICE: UnCuffed ETT

ClinicalTrials.gov

Antiepileptic Drugs in Elderly Patients

Brief Summary: The purpose is to study the population pharmacokinetics, effectiveness and safety of antiepileptic drug (phenytoin, carbamazepine, lamotrigine, levetiracetam, parempanel, etc) in elderly patients and recommend optimized dosage regimens.

Recruiting

Start Date:
2021-01-01

Close Date:
2028-06-30

Interventions:

DRUG: antiepileptic drugs

Recruiting

Start Date:
2021-01-01

Close Date:
2028-06-30

Interventions:

DRUG: antiepileptic drugs

ClinicalTrials.gov

Volatile Non-Invasive Biomarkers of Epileptic Seizures

Brief Summary: Breath and sweat samples will be collected from people who have been admitted to hospital after a potential seizure and analysed by the team. The researchers then hope to identify a pattern of small molecules that can distinguish seizures from other events, and perhaps determine the severity of the seizure.

Recruiting

Start Date:
2023-01-30

Close Date:
2026-11-01

Interventions:

OTHER: Sample Collection

Recruiting

Start Date:
2023-01-30

Close Date:
2026-11-01

Interventions:

OTHER: Sample Collection

ClinicalTrials.gov

Performance and Effectiveness of a Self-fitting Over-the-counter Hearing Aid

Brief Summary: Hearing loss significantly affects quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a proven intervention, yet barriers like access and affordability limit their adoption, even in high-income countries with developed audiological services . Traditionally, hearing aids required professional consultations, restricting access. However, in 2022, the U.S. FDA approved over-the-counter (OTC) hearing aids, including self-fitting devices, to improve accessibility. Recent clinical trials suggest that OTC hearing aids can deliver similar benefits to professionally fitted ones in speech recognition and self-reported outcomes. Critiques of these studies have focused on using the same device model for both groups rather than comparing it to established prescription hearing aids. To address this, the current study employs a phased approach. Phase 1 validates an in-situ hearing test against a standard audiometer, Phase 2 assesses user experience, and Phase 3 involves a randomized control trial comparing a self-fitting OTC hearing aid with a professionally fitted prescription device. The hypothesis is that both devices offer equivalent benefits. This research is novel as no previous studies have directly compared self-fitting OTC and commercially available prescription hearing aids. This study will compare the effectiveness of an OTC self-fitting hearing aid against a prescription device using a crossover randomized control trial.

Not yet recruiting

Start Date:
2025-09-01

Close Date:
2025-12-31

Interventions:

DEVICE: OTC self-fitting hearing aid
DEVICE: Prescription hearing aid

Not yet recruiting

Start Date:
2025-09-01

Close Date:
2025-12-31

Interventions:

DEVICE: OTC self-fitting hearing aid
DEVICE: Prescription hearing aid

ClinicalTrials.gov

Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study

Brief Summary: The aim of this study is to investigate the pregnancy, delivery, neonatal, and epilepsy outcomes in individuals with epilepsy undergoing pregnancy at the Maternal and Infant Health Programs at the University Health Network - Sinai Health and followed for epilepsy at the Toronto Western Hospital Epilepsy Clinic. In particular, we are interested in the association between following recommended epilepsy management guidelines for pregnant individuals with epilepsy and those aforementioned outcomes.

Recruiting

Start Date:
2022-07-20

Close Date:
2026-01-01

Recruiting

Start Date:
2022-07-20

Close Date:
2026-01-01

ClinicalTrials.gov

Identification of Volatile Organic Compounds (VOCs) as Biopredictors of Epileptic Seizures

Brief Summary: The unpredictable nature of epileptic seizures places people with epilepsy under permanent psychological stress, which contributes significantly to a restriction in their quality of life. The possibility of predicting the arrival of epileptic seizures would allow, in addition to taking a preventive treatment if the risk of seizure is close, to prevent traumas and accidents linked to possible falls during seizures, to authorize driving for certain people with epilepsy and to reduce the costs of medical care. To date and to our knowledge, no seizure detection device has been commercialized. There are commercialized devices based on biometric sensors other than EEG, but these are strictly dedicated to the detection of seizures and do not allow the anticipation of seizures. Regarding prediction, current research seems to have difficulties in developing convincing algorithms. The only system used successfully in real time would require a device implantable in the brain, but this would raise problems of acceptability. In addition, 20% of people with drug-resistant epilepsy have psychogenic non-epileptic seizures (PNES). These are sometimes difficult to differentiate from epileptic seizures by people with epilepsy and their caregivers, and their management differs from that of epileptic seizures. The distinction between these 2 types of events should also be taken into account by these prediction/detection tools. From the field of biomedical detection dogs, there is currently a converging body of evidence supporting that people with epilepsy emit specific odors associated with seizure events. Trained dogs have been shown to be able to discriminate body odors sampled during or just after an epileptic seizure from those sampled from the same subjects in various contexts outside of a seizure. It was also shown that a seizure can also be predicted by the volatile organic compounds (VOCs) released by the patient (human volatilome); the olfactory signature being already detectable up to 3h before a seizure. Another study used trained dogs to confirm that they are able to detect a seizure by smell and that this olfactory difference is already detectable before a seizure. The human volatilome VOCs lead is particularly promising, notably for its non-invasiveness and for the pre-ictal precocity that prediction allows. But at the moment, the studies are too studies are too preliminary, with sample sizes too small to conclude on the inter-individual generalization of the odor, taking into account the type of seizure involved and the influence of other variables (e.g., gender, age, medications). Moreover, in order to develop a reliable and transportable electronic detection tool, the identification of the VOCs involved is necessary, since the choice of sensors (e.g., to constitute an electronic nose) depends on it. The objective of this study is to overcome these shortcomings, by aiming at the identification of the informative odor(s) associated with epileptic events during the pre-ictal, ictal and post-ictal periods, taking into account the type of seizures (focal seizures, secondary generalized focal seizures, primary generalized seizures - motor and non-motor) and the inter-individual differences.

Recruiting

Start Date:
2024-02-03

Close Date:
2025-10-03

Interventions:

OTHER: VOC sampling

Recruiting

Start Date:
2024-02-03

Close Date:
2025-10-03

Interventions:

OTHER: VOC sampling

ClinicalTrials.gov

A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

Brief Summary: The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

Recruiting

Start Date:
2021-03-11

Close Date:
2030-07-08

Interventions:

DRUG: Brivaracetam

Recruiting

Start Date:
2021-03-11

Close Date:
2030-07-08

Interventions:

DRUG: Brivaracetam

ClinicalTrials.gov

Evaluating the Clinical Effectiveness of a Community-based Hearing Aid Fitting Service Delivery Model Facilitated by Community Healthcare Workers (CHWs) Providing Smartphone-based In-situ and Pre-set Hearing Aid Fittings in Low- and Middle-income Communities (LMICs)

Brief Summary: The purpose of this study is to advance hearing care in low- and middle-income countries (LMICs) through the rigorous evaluation and optimization of innovative interventions and technologies. This study encompasses the following key aim: This study aims to establish the effectiveness of community-based hearing aid fittings facilitated by community healthcare workers (CHWs) using mobile health (mHealth) technologies in low- and middle-income communities (LMICs). The primary goal is to determine the efficacy of CHW-facilitated smartphone-based in-situ hearing aid (HA) fittings (a proprietary fitting based on the NAL-NL2 algorithm) and pre-set HAs fittings compared to minimal amplification through a single-blind randomized controlled trial (RCT). By comparing self-reported benefits between the experimental and control groups, this aim seeks to demonstrate the superiority of the CHW-facilitated smartphone-based and pre-set hearing aid fittings compared to minimal amplification.

Recruiting

Start Date:
2025-05-21

Close Date:
2026-12-15

Interventions:

DEVICE: Lexie Lumen Hearing Aids
DEVICE: Go Ultra Hearing Aids

Recruiting

Start Date:
2025-05-21

Close Date:
2026-12-15

Interventions:

DEVICE: Lexie Lumen Hearing Aids
DEVICE: Go Ultra Hearing Aids

ClinicalTrials.gov

Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery

Brief Summary: The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.

Recruiting

Start Date:
2024-02-10

Close Date:
2025-01-01

Interventions:

DRUG: TXA
DIAGNOSTIC_TEST: TEG6

Recruiting

Start Date:
2024-02-10

Close Date:
2025-01-01

Interventions:

DRUG: TXA
DIAGNOSTIC_TEST: TEG6

ClinicalTrials.gov

Long-term Safety and Tolerability of BHV-7000

Brief Summary: A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy

Enrolling by invitation

Start Date:
2024-07-30

Close Date:
2027-01

Interventions:

DRUG: BHV-7000
DRUG: BHV-7000

Enrolling by invitation

Start Date:
2024-07-30

Close Date:
2027-01

Interventions:

DRUG: BHV-7000
DRUG: BHV-7000

ClinicalTrials.gov

Severity of Hypoxic Ischemic Encephalopathy and Neurological Pupil Index in Neonates

Brief Summary: The goal of this observational study is to learn if the reactivity of a newborn's eye to light (measured as an index, using a new device -pupillometer) reflect the health of their brain recovering from disruption of blood/oxygen supply during birth (Hypoxic Ischemic Encephalopathy-HIE). The main questions it aims to answer are: * With a decreasing reactivity index, does the chance of an abnormal electrical function of brain (noted by electroencephalography (EEG)) increase? * With a decreasing reactivity index, do the odds of an indicator of severe impact on brain health (abnormal brain imaging, seizures, feeding difficulty) increase? Participants will undergo eye examination using the pupillometer instead of the regular penlight, as part of their routine neurological examination. This will not change the way in which the newborn is being treated and managed medically.

Not yet recruiting

Start Date:
2025-08

Close Date:
2026-06

Interventions:

DEVICE: Automated Pupillometer

Not yet recruiting

Start Date:
2025-08

Close Date:
2026-06

Interventions:

DEVICE: Automated Pupillometer

ClinicalTrials.gov

Mapping of Human Cognition

Brief Summary: The purpose of this study is to compare organization of normal brain function as detected using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to patients with epilepsy or brain tumors, to ascribe precise anatomic labels (including Brodmann Areas) and functional significance to each region involved in cognitive processes as detected by cortical stimulation mapping (CSM) in patients with implanted subdural electrodes (SDE) or depth (sEEG) electrodes, to describe the locations of these regions in Talairach space, for a population of patients without overt structural abnormalities in these regions, to generate a spatial probability map of locations of cortical regions "essential" for these processes, to compare the loci of "crucial" language, visual, motor and cognitive sites as determined by CSM with the loci determined by a battery of tasks using fMRI for each individual and to use these data in patients undergoing intracranial electro-corticographyto determine the loci of essential, involved and uninvolved brain areas, and use sophisticated mathematical analyses of these intracranial recordings to study information flow between these areas.

Recruiting

Start Date:
2022-08-01

Close Date:
2027-07-31

Interventions:

BEHAVIORAL: Language-based tasks

Recruiting

Start Date:
2022-08-01

Close Date:
2027-07-31

Interventions:

BEHAVIORAL: Language-based tasks

ClinicalTrials.gov

Impact of Thermocoagulation During Invasive EEG Monitoring in Children With Focal Drug-resistant Epilepsies

Brief Summary: When focal epilepsies become drug-resistant, it could be eligible for cortical surgical resection. Therefore, an invasive EEG monitoring with depth electrodes is often needed during presurgical evaluation. Some of these children can have access to thermocoagulation inside the ictal onset zone, at the end of the monitoring and before to remove the electrodes. These thermocoagulations can disorganize the epileptogenic network thanks to millimetric cortical lesions around the electrodes. The aim is to stop or at least, to reduce the seizure frequency for few weeks or months. This could be a benefit for the child, and also a confirmation of the ictal onset zone and guide the surgeon. This technique is currently used in adult population for years, but remains very rare in children.

Recruiting

Start Date:
2015-12

Close Date:
2024-06-11

Interventions:

PROCEDURE: Thermocoagulation

Recruiting

Start Date:
2015-12

Close Date:
2024-06-11

Interventions:

PROCEDURE: Thermocoagulation

ClinicalTrials.gov

A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome

Brief Summary: This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).

Recruiting

Start Date:
2020-09-15

Close Date:
2029-05-01

Interventions:

DRUG: Clemizole HCl
DRUG: Placebo

Recruiting

Start Date:
2020-09-15

Close Date:
2029-05-01

Interventions:

DRUG: Clemizole HCl
DRUG: Placebo

ClinicalTrials.gov

PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest

Brief Summary: Brain injury is the main cause of death and disability for patients surviving cardiac arrest resuscitation and seizures are diagnosed in up to a third of these patients. The investigators are proposing a pilot randomized placebo-controlled clinical trial to evaluate the safety and feasibility of perampanel use for post-cardiac arrest status epilepticus (PCARSE) prevention after cardiac arrest.

Recruiting

Start Date:
2024-05-20

Close Date:
2026-10-20

Interventions:

DRUG: Perampanel
DRUG: Placebo

Recruiting

Start Date:
2024-05-20

Close Date:
2026-10-20

Interventions:

DRUG: Perampanel
DRUG: Placebo

ClinicalTrials.gov

Optimizing Brain Stimulation Parameters

Brief Summary: A primary purpose of this study is to better understand what stimulation parameters work best for patients. For example, for Deep Brain Stimulation (DBS) of the Anterior Nucleus of the Thalamus (ANT), it is not clear what stimulation frequency leads is most effective. This study will help assess the effectiveness of low frequency or high frequency stimulation.

Recruiting

Start Date:
2020-10-20

Close Date:
2028-09-01

Interventions:

DEVICE: Stimulation Set A and B

Recruiting

Start Date:
2020-10-20

Close Date:
2028-09-01

Interventions:

DEVICE: Stimulation Set A and B

ClinicalTrials.gov

De-identified UNMH EEG Corpus Database Creation With Fully De-identified Clinical Information

Brief Summary: This proposal outlines the steps required for the creation of a pilot database of EEG recordings and de-identified medical records from patients internally referred within the UNMH Comprehensive Epilepsy Center. The UNMH EEG Corpus would be the first database of its kind. Other public databases contain either patient EEG signals or medical records, but without both kinds of information, it is impossible to relate pre-treatment neurobiomarkers with post-treatment prognosis. The database will also contain information that can improve seizure localization based off of scalp and intracranial EEG, and the requisite data for the creation of algorithms that forecast seizure activity; a development that could ultimately lead to novel responsive neural stimulation procedures that suppress seizures before they begin.

Recruiting

Start Date:
2021-10-11

Close Date:
2030-12-31

Recruiting

Start Date:
2021-10-11

Close Date:
2030-12-31

ClinicalTrials.gov

A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors

Brief Summary: The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161 as a single agent and in combination with pembrolizumab.

Recruiting

Start Date:
2023-04-05

Close Date:
2027-05

Interventions:

DRUG: IDE-161
DRUG: Pembrolizumab

Recruiting

Start Date:
2023-04-05

Close Date:
2027-05

Interventions:

DRUG: IDE-161
DRUG: Pembrolizumab

ClinicalTrials.gov

Ketamine and Levetiracetam as Second-line Antiseizure Medication for Status Epilepticus in Children

Brief Summary: About 40% of children with generalized convulsive status epilepticus (GCSE) are not terminated by first-line benzodiazepines (BDZs), and approximately 50% of BDZ-refractory GCSE are not controlled by second-line antiseizure medications. This study investigates the efficacy of ketamine-levetiracetam combination vs. levetiracetam alone for treating children with BDZ-refractory GCSE.

Recruiting

Start Date:
2025-07-02

Close Date:
2026-07-01

Interventions:

DRUG: Ketamine
DRUG: Levetiracetam
DRUG: Placebo

Recruiting

Start Date:
2025-07-02

Close Date:
2026-07-01

Interventions:

DRUG: Ketamine
DRUG: Levetiracetam
DRUG: Placebo

ClinicalTrials.gov

Longitudinal Study of Neurogenetic Disorders

Brief Summary: The purpose of this study is to analyze patterns in individuals with hnRNP (and other) genetic variants, including their neurological comorbidities, other medical problems and any treatment. The investigators will maintain an ongoing database of medical data that is otherwise being collected for routine medical care. The investigators will also collect data prospectively in the form of questionnaires, neuropsychological assessments, motor assessments, and electroencephalography to examine the landscape of deleterious variants in these genes.

Recruiting

Start Date:
2018-06-13

Close Date:
2030-12

Recruiting

Start Date:
2018-06-13

Close Date:
2030-12

ClinicalTrials.gov

Effectiveness of MST Versus ECT for Major Depressive Episode

Brief Summary: Despite advancements in Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) for Major Depressive Disorder (MDD), there remains a need for further research to replicate clinical outcomes and understand the therapeutic targets of these treatments. This study aims to address these gaps through a double-blinded, randomized, non-inferiority investigation comparing the efficacy, tolerability, cognitive adverse effects, and neurophysiological biomarkers of MST and bilateral ECT in patients with MDD.

Recruiting

Start Date:
2024-08-01

Close Date:
2026-12-30

Interventions:

DEVICE: MST
DEVICE: ECT

Recruiting

Start Date:
2024-08-01

Close Date:
2026-12-30

Interventions:

DEVICE: MST
DEVICE: ECT

ClinicalTrials.gov

Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation-2 (TELSTAR-2)

Brief Summary: The goal of this comparative effectiveness trial is to study electrographic status epilepticus (ESE) treatment in comatose patients after cardiac arrest. The main questions the trial aims to answer are: * Does ESE treatment improve outcome? * What is the impact of ESE treatment on healthcare costs? Participants in the the intervention group will receive standard care completed with anti-seizure treatment. The control group will receive standard care without anti-seizure treatment.

Recruiting

Start Date:
2025-04-10

Close Date:
2030-12

Interventions:

DRUG: anti-seizure medication + sedative agent(s)

Recruiting

Start Date:
2025-04-10

Close Date:
2030-12

Interventions:

DRUG: anti-seizure medication + sedative agent(s)

ClinicalTrials.gov

MST for Parkinson's Disease

Brief Summary: This trial aims to test the feasibility of Magnetic Seizure Therapy (MST) for Depression in patients diagnosed with Parkinson's Disease.

Active, not recruiting

Start Date:
2021-09-20

Close Date:
2025-02

Interventions:

DEVICE: Magnetic Seizure Theapy (MagPro XP MST)

Active, not recruiting

Start Date:
2021-09-20

Close Date:
2025-02

Interventions:

DEVICE: Magnetic Seizure Theapy (MagPro XP MST)

ClinicalTrials.gov

Seizure Identification on the Intensive Care Unit (ICU)

Brief Summary: The aim of this project is to assess the ability of different groups of National Heath Service (NHS) professionals to correctly identify clinical seizures, and distinguish them from other movements commonly seen in the ICU environment, when shown digital video recordings only. Patients on the ICU are at risk of having seizures, however also commonly make other movements, including shivering, jerking, tics and tremors. An Electroencephalogram (EEG) records the brain wave activity and can help distinguish epileptic seizures from other movements. In a study by Bendadis et al (2010), 52 video-EEGs were reviewed containing "possible seizures" on the ICU. They found only 27% recorded actual epileptic events, with the other 73% having a range of other movements. Malone et al (2009) studied accuracy of diagnosis of 20 video recordings of clinical episodes on the neonatal unit, comparing different staff groups. They found no significant difference between Doctors and Nurses in correctly identifying seizures, however found that accuracy of diagnosis was generally poor. Clinical scientists are currently expanding their roles and responsibilities across Neurophysiology, including giving consultant-level advice on EEG investigations. EEG recordings on the ICU are often obscured by excessive, unavoidable electrical/movement artefacts caused by equipment such ventilators and pumps, and patient factors such as position, breathing artefact and suctioning. These make the EEG difficult to interpret (Boggs 2021). Assessing the clinical signs and symptoms which we may see in ICU patients, in the absence of interpretable EEG, is an essential skill. This study aims to assess Clinical Scientists skills at clinical interpretation, in comparison with other staff groups in the ICU setting. Staff will be asked to watch video clips of events captured in the ICU, and tell us whether they think they are seizures or not, and explain their thought process behind the decision.

Recruiting

Start Date:
2025-03-03

Close Date:
2025-08-31

Interventions:

OTHER: Clinical Opinion

Recruiting

Start Date:
2025-03-03

Close Date:
2025-08-31

Interventions:

OTHER: Clinical Opinion

ClinicalTrials.gov

Dual Anti-glutamate Therapy in Super-refractory Status Epilepticus After Cardiac Arrest

Brief Summary: Status epilepticus (SE) is found in 20-30% of patients in coma after cardiac arrest, is often refractory to medical therapy and is considered a negative prognostic factor. Intensity and duration of treatment of refractory and super-refractory post-anoxic SE pose the ethical dilemma between futility of treatments and, conversely, their premature suspension. A recent study by the Epilepsy Center of the San Gerardo Hospital has shown that patients with super-refractory post-anoxic SE and favorable prognostic indicators can achieve a good functional outcome in more than 40% of cases, if treated with intensive and protracted therapy. However, there is profound uncertainty about the best combination of antiseizure medications and anesthetics to use in this condition. A combined anti-glutamatergic therapy with ketamine (anti-NMDA receptor) and perampanel (anti-AMPA receptor), aimed at counteracting the excitotoxicity linked to global cerebral ischemia, could be particularly effective in the treatment of super-refractory SE with post-anoxic etiology. Preliminary results in the first 26 patients treated in the Coordinating Center of the project indicate that this therapy appears safe and highly effective (80% SE resolution, 40% good neurological outcome). The aim of the SUPER-CAT study is to investigate the efficacy and safety of combined therapy with ketamine and perampanel (dual anti-glutamatergic therapy) in patients with post-anoxic super-refractory status epilepticus, compared to other therapies, using a multi-centre, retrospective, cohort study design.

Recruiting

Start Date:
2022-01-15

Close Date:
2025-09-30

Interventions:

DRUG: Ketamine
DRUG: Any anti-epileptic and anesthetic therapy, excluding Ketamine and Perampanel

Recruiting

Start Date:
2022-01-15

Close Date:
2025-09-30

Interventions:

DRUG: Ketamine
DRUG: Any anti-epileptic and anesthetic therapy, excluding Ketamine and Perampanel

ClinicalTrials.gov

EEG Monitoring for Refractory Status Epilepticus

Brief Summary: This is a prospective randomized study to investigate the yield of continuous electroencephalogram (cEEG), as a diagnostic tool in intensive care unit (ICU), for patients with refractory status epilepticus (RSE) and the contribution of this test to the patient final outcome, compared with standard medical care. Specifically, the hypothesis is that the use of cEEG for patients with RSE will significantly reduce the length of in-hospital stay, mortality, and subsequent complications (such as infections or pressure ulcers). It is also predicted that quality of life will be higher following cEEG at 0, 3, 6 and 12 months after discharge. As there are currently no data available from previous studies assessing the impact of cEEG on markers of the final clinical outcome in patients with RSE, this study is going to start as a feasibility study, aiming to obtain initial data for the primary outcome measure, in order to perform a sample size calculation for a larger future trial. The pilot study will also assess the integrity of the study protocol, specifically the recruitment process and the consent procedure, and also determine the necessary costs for running a cEEG service in ICU for patients with RSE

Recruiting

Start Date:
2020-03-17

Close Date:
2027-01

Interventions:

DIAGNOSTIC_TEST: Continuous EEG

Recruiting

Start Date:
2020-03-17

Close Date:
2027-01

Interventions:

DIAGNOSTIC_TEST: Continuous EEG

ClinicalTrials.gov

Baseline Performance and Fitting Parameters for Sonova Products

Brief Summary: The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.

Enrolling by invitation

Start Date:
2023-04-17

Close Date:
2028-04-17

Interventions:

DEVICE: Pinna-located microphone
DEVICE: Pinna-simulated microphone algorithm

Enrolling by invitation

Start Date:
2023-04-17

Close Date:
2028-04-17

Interventions:

DEVICE: Pinna-located microphone
DEVICE: Pinna-simulated microphone algorithm

ClinicalTrials.gov

Comparative Effectiveness of Palliative Surgery Versus Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome

Brief Summary: Lennox-Gastaut syndrome is a serious and rare form of epilepsy that begins in infancy and early childhood. Seizures and their consequences need medical attention, emergency encounters, and hospitalizations. Seizures disrupt home life for the patient and for family. Lennox-Gastaut syndrome is typically accompanied by disabilities in motor, communication, eating, and other skills needed for daily function. Lennox-Gastaut syndrome (LGS) has no cure. Although current treatments may help reduce the number of seizures, none are expected to eliminate them entirely; these treatments are palliative. The main treatments include anti-seizure medications and some surgical approaches, including the implantation of a vagus nerve stimulator (a pacemaker-like generator implanted in the chest wall and programmed by a physician to stimulate the vagus nerve in the neck) and corpus callosotomy (cutting through the band of fibers that connect the two sides of the brain). While both types of treatment (medications and surgeries) produce some benefit by reducing how often the seizures occur, both also have some risks. All medications can, in some patients, produce moderate to severe side effects. This is true of anti-seizure medications. Most patients with LGS take several anti-seizure medications at a time. Surgeries can also have associated risks and is additionally stressful for parents and family members. Currently, there is no strong evidence to support parents and physicians in deciding which type of treatment (more medicines or surgery) will be most successful for a child with LGS, and whether one or the other approach may lessen the toll that seizures take on a child's development and ability to function. This study has two components. It will engage a network of seven pediatric hospitals in the United States where children with Lennox-Gastaut syndrome are cared for and determine whether seizure-related emergency department visits and hospitalizations are more likely to be reduced following the use of additional medications or adding palliative surgery to existing medications. The investigators will determine whether medical versus surgical treatment is more likely to lessen some of the developmental and functional difficulties that affect patients with LGS. The study will also determine whether starting therapies at a younger versus older age makes a difference. The second component of the study will provide a description of the use of surgical versus medical treatment approaches across 18 pediatric hospitals in the United States (seven plus 11 centers). The investigators will describe how treatments differ across hospitals and over time. The results from this study will help parents and providers make more informed choices about treatment for children with Lennox-Gastaut syndrome and will highlight areas for improvement in providing the best possible health care for this severe, lifelong disorder.

Recruiting

Start Date:
2022-04-01

Close Date:
2025-08-31

Recruiting

Start Date:
2022-04-01

Close Date:
2025-08-31

ClinicalTrials.gov

Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms

Brief Summary: Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial

Not yet recruiting

Start Date:
2025-11-24

Close Date:
2027-12-31

Interventions:

DEVICE: DBS Arm
DEVICE: VNS arm

Not yet recruiting

Start Date:
2025-11-24

Close Date:
2027-12-31

Interventions:

DEVICE: DBS Arm
DEVICE: VNS arm

ClinicalTrials.gov

Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray

Brief Summary: Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning. Pistoning can lead to gait instability, skin problems, and pain. Different prosthetic suspension systems have been developed to decrease this motion, including elevated vacuum suspension, which utilizes a pump to draw air from the socket. However, scientific analyses to understand the movement between the limb and socket have yet to be performed with a high level of accuracy. This study will use a state-of-the art imaging technique, known as dynamic stereo x-ray, to quantify the 3D movement of the residual limb in the socket. It is hypothesized that dynamic stereo x-ray will be a sensitive method to measure differences in residual limb movement between 2 different socket suspension techniques: suction and elevated vacuum suspension. This information is critical for advancing prosthetic treatments to reduce secondary conditions and degenerative changes that result from poor prosthetic fit.

Recruiting

Start Date:
2024-01-05

Close Date:
2026-03-31

Interventions:

DEVICE: Suction Suspension First
DEVICE: Elevated Vacuum Suspension First

Recruiting

Start Date:
2024-01-05

Close Date:
2026-03-31

Interventions:

DEVICE: Suction Suspension First
DEVICE: Elevated Vacuum Suspension First

ClinicalTrials.gov

Sleep Disruption Pattern - Epilepsy Monitoring Unit

Brief Summary: Epilepsy affects millions worldwide, with 40% of patients experiencing uncontrolled seizures despite medication. Comprehensive epilepsy centers recommend continuous video-electroencephalography monitoring to define seizure type and distinguish mimickers. This process, however, is resource-intensive, with lengthy hospital stays. The investigators' recent study identified a heightened association between arousals and epileptic activity in drug-resistant focal epilepsy patients. Building on these findings, the investigators aim to explore whether disrupting sleep with an alarm system triggers earlier occurrence of seizures, potentially offering insights to reduce hospital stay durations in epilepsy monitoring units.

Not yet recruiting

Start Date:
2025-12-01

Close Date:
2026-12-01

Interventions:

DEVICE: Alarm system

Not yet recruiting

Start Date:
2025-12-01

Close Date:
2026-12-01

Interventions:

DEVICE: Alarm system

ClinicalTrials.gov

Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients

Brief Summary: The main goal of this project is to study the mechanisms of epileptic activities using intracranial macro and micro electrodes in epileptic patients undergoing pre-surgical investigation. The recordings will also be used to study physiological mechanisms like sleep and different cognitive functions.

Recruiting

Start Date:
2021-02-28

Close Date:
2031-02-27

Interventions:

DEVICE: Intracranial macro-microelectrode recording

Recruiting

Start Date:
2021-02-28

Close Date:
2031-02-27

Interventions:

DEVICE: Intracranial macro-microelectrode recording

ClinicalTrials.gov

Pulvinar Stimulation in Epilepsy: a Pilot Study

Brief Summary: Deep brain stimulation (DBS) is one of the neuromodulation techniques that can be indicated in patients suffering from refractory epilepsies, especially when an open resection has failed or is not indicated, and vagal nerve stimulation (VNS) demonstrated no efficacy. Benefits such as reduction of seizure frequency have been shown for thalamic stimulation of the anterior thalamic nucleus (ANT), however it has limited efficacy and non-optimal neurocognitive outcome, making the search for other targets crucial in this context. We propose a novel target for DBS stimulation in drug-resistant epilepsy namely the medial pulvinar thalamic nucleus (PuM). This target has been chosen based on previous retrospective studies demonstrating that PuM is involved during focal seizures and in loss of consciousness and seizure termination. PuM stimulation also showed potential encouraging results based on the feasibility and safetu studies recently published. The main objective is to obtain a significant percentage of seizure reduction after 12 months of PuM stimulation compared to baseline period. Quality of life and the relationship with psychiatric and cognitive comorbidities will also be assessed.

Active, not recruiting

Start Date:
2021-01-15

Close Date:
2026-10-23

Interventions:

DEVICE: Pulvinar deep brain stimulation

Active, not recruiting

Start Date:
2021-01-15

Close Date:
2026-10-23

Interventions:

DEVICE: Pulvinar deep brain stimulation

ClinicalTrials.gov

Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy

Brief Summary: This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine if RAP-219 works and is safe in patients with Refractory Focal Epilepsy.

Active, not recruiting

Start Date:
2024-10-10

Close Date:
2025-09-22

Interventions:

DRUG: RAP-219

Active, not recruiting

Start Date:
2024-10-10

Close Date:
2025-09-22

Interventions:

DRUG: RAP-219

ClinicalTrials.gov

Comparing Intravenous and Intramuscular Magnesium Sulphate for Preventing Seizure Recurrence in Women With Eclampsia

Brief Summary: The goal of this clinical study is to learn whether the way we give magnesium sulphate-into a vein (intravenous, IV) versus into a muscle (intramuscular, IM)-affects how often women with eclampsia have repeat seizures. The main question it aims to answer is: 1\. Do women who receive IV magnesium sulphate have fewer recurrent seizures than those who receive IM magnesium sulphate? Researchers will compare two groups of women with eclampsia: one group will receive a bolus and a continuous IV infusion of magnesium sulphate, and the other will receive a combined IV-plus-IM dosing regimen. Participants will: 1. Be women aged 18-45 years diagnosed with eclampsia in the labour room. 2. Have their basic health information (age, gestation, parity, body mass index) recorded 3. Be randomly assigned (by sealed envelope) to receive either the IV regimen (4 g loading dose then 1 g/hour infusion) or the IM regimen (10 g loading dose with 4 g IV plus 6 g IM, then 2.5 g IM every 4 hours). 4. Continue treatment for 24 hours after their last seizure or delivery, whichever is later. 5. Be monitored in hospital for seizure recurrence. 6. Have any repeat seizure treated immediately with an extra IV dose of magnesium sulphate.

Recruiting

Start Date:
2025-05-13

Close Date:
2025-11-12

Interventions:

DRUG: Magnesium Sulphate infusion
DRUG: Magnesium sulphate intramuscular

Recruiting

Start Date:
2025-05-13

Close Date:
2025-11-12

Interventions:

DRUG: Magnesium Sulphate infusion
DRUG: Magnesium sulphate intramuscular

ClinicalTrials.gov

Double-blind, Randomized, Placebo-controlled Trial of Ganaxolone in CDKL5 Deficiency Patients 6 Months to Less Than 2 Years Old

Brief Summary: This study will assess the efficacy, safety, and tolerability of ganaxolone (GNX) compared with placebo (PBO) as adjunctive therapy to the participant's standard anti-epileptic medication for the treatment of seizures in pediatric patients from 6 months to less than 2 years old with genetically confirmed CDD during a 12-week, DB phase. Pharmacokinetic (PK) assessments and population PK analyses will also be performed during this time. The DB phase will be followed by an optional long-term OL phase at which time all participants will receive GNX as an adjunct to their standard anti-seizure medication. Efficacy, safety and tolerability, and PK assessments will continue to be performed.

Not yet recruiting

Start Date:
2024-12

Close Date:
2027-03

Interventions:

DRUG: Ganaxolone
DRUG: Placebo

Not yet recruiting

Start Date:
2024-12

Close Date:
2027-03

Interventions:

DRUG: Ganaxolone
DRUG: Placebo

ClinicalTrials.gov

Artificial Intelligence-based Video Analysis to Detect Infantile Spasms

Brief Summary: Infantile spasms are a type of seizure linked to developmental issues. Unfortunately, they are often misdiagnosed, causing delays in treatment. The purpose of this study is to develop a computer program that can reliably differentiate infantile spasms from similar, yet benign movements in videos. This computer program will learn from videos taken by parents of study participants. Quickly recognizing and treating infantile spasms is crucial for ensuring the best developmental outcomes.

Recruiting

Start Date:
2024-08-26

Close Date:
2026-05

Interventions:

DEVICE: Spasm Vision

Recruiting

Start Date:
2024-08-26

Close Date:
2026-05

Interventions:

DEVICE: Spasm Vision

ClinicalTrials.gov

Patient-reported Outcome and Patient-reported Experience After Status Epilepticus

Brief Summary: Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments. The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied. Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term postresuscitation syndrome (PICS), neuronal lesions consecutive to the SE itselfor to its cause could be responsible for these different functional alterations. Thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress. Assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. The POSEIDON study was a cross-sectional collection of PROs and HR-QOL components, and associated with patient functional outcomes, in those who required ICU management for status epilepticus. We propose here to continue the description of potential alterations after a subsequent ME, namely a longitudinal study (POSEIDON 2) which will also include the evaluation of patient-reported experience (PREMS) and the measurement of family burden.

Recruiting

Start Date:
2024-05-25

Close Date:
2026-07

Recruiting

Start Date:
2024-05-25

Close Date:
2026-07

ClinicalTrials.gov

Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures

Brief Summary: The primary objective of this study is to assess the pharmacokinetics of cenobamate (YKP3089) in pediatric subjects with partial-onset (focal) seizures following single and multiple-dosing.

Recruiting

Start Date:
2021-05-27

Close Date:
2026-03

Interventions:

DRUG: Xcopri

Recruiting

Start Date:
2021-05-27

Close Date:
2026-03

Interventions:

DRUG: Xcopri

ClinicalTrials.gov

Trial of Multi-Strain Probiotic Supplementation (Hexbio®) in Malaysian Patients With Drug-Resistant Epilepsy (ProbE)

Brief Summary: Probiotics are good, live bacteria and/or yeast, that live in our guts and causes no harm. They help in digestion and overall well-being of our gut system. The purpose of the study is to assess the effect of probiotics on the quality of life and seizure frequency in epilepsy patients with uncontrolled seizures. This experimental study involves an interview by the researchers from UKM for the demographic of epilepsy, seizure control and quality of life using a questionnaire. The questionnaire will take about 15 minutes to complete, and you will need to answer all questions without assistance. You will be randomized either into the active group or the placebo group. If you are in the active group, you will need to take one HEXBIO MCP Granule probiotics sachet directly before meal (drink water if needed) twice daily, for two months, in addition to your pre-existing epilepsy treatment. The HEXBIO MCP Granule probiotic consists of the following probiotics: Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium infantis and Bifidobacterium longum. Initially, some people may experience temporary mild gastrointestinal symptoms such as abdominal cramping, soft stools and flatulence as body adapts to the introduction of friendly bacteria. The symptoms will subside gradually after few days. If you are in the placebo group, you will also need to take one sachet twice daily before meal, for two months, in addition to the epilepsy treatment. The placebo sachets will contain the same ingredient as the probiotic sachet but without the Lactobacillus sp. and Bifidobacterium sp. The placebo sachet is also to be taken the same way as the probiotic sachet. At two months of follow up, you will be interviewed once again to assess the changes of seizure frequency (using seizure diary), quality of life and the adverse effects of experienced. A sachet-count (using sachet diary) will also be done to assess the compliance. Benefits This study is done in an attempt to assess the changes in quality of life and seizure frequency in patients with refractory epilepsy as compared to the control group. Risks There is no risk in this study. All information disclosed during this study is strictly confidential. You do not have to pay to participate in this study. If seizure or quality of life worsened during this period, you will be referred to the respective team for the optimization of anti-seizure medications. Do you have to take part? Participation in this study is voluntary. If you agree to take part, then you will be asked to sign the "informed Consent Form". Should you decide to participate, you can still withdraw at any time during the study without penalty. Your data will be discarded and not be used. Regardless of your decision at any point in time, your treatment will not be affected. Data and Confidentiality The data in this study will be made into a report which may be published. The data will be reported in a collective manner with no reference to an individual. Hence your identity will be kept confidential. There is no conflict of interest among the researchers.

Active, not recruiting

Start Date:
2023-04-03

Close Date:
2026-03-02

Interventions:

DIETARY_SUPPLEMENT: Probiotic Agent
DIETARY_SUPPLEMENT: Placebo

Active, not recruiting

Start Date:
2023-04-03

Close Date:
2026-03-02

Interventions:

DIETARY_SUPPLEMENT: Probiotic Agent
DIETARY_SUPPLEMENT: Placebo

ClinicalTrials.gov

Genetics of Epilepsy and Related Disorders

Brief Summary: Investigators at Boston Children's Hospital are conducting research in order to better understand the genetic factors which may contribute to epilepsy and related disorders. These findings may help explain the broad spectrum of clinical characteristics and outcomes seen in people with epilepsy.

Recruiting

Start Date:
2010-11

Close Date:
2030-12

Interventions:

GENETIC: Exome and/or whole genome sequencing

Recruiting

Start Date:
2010-11

Close Date:
2030-12

Interventions:

GENETIC: Exome and/or whole genome sequencing

ClinicalTrials.gov

Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

Brief Summary: Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures

Recruiting

Start Date:
2022-01-14

Close Date:
2026-07

Interventions:

DRUG: Xcopri

Recruiting

Start Date:
2022-01-14

Close Date:
2026-07

Interventions:

DRUG: Xcopri

ClinicalTrials.gov

5-SENSE Score Validation Study

Brief Summary: The purpose of this study is to assess how well a new scoring system called the 5-SENSE score can predict where seizures start in the brain using Stereoelectroencephalography (SEEG). The 5-SENSE Score is a 5-point score based on routine presurgical work-up, designed to assist in predicting whether SEEG can identify a focal seizure onset zone, thereby sparing patients the risk of undergoing this invasive diagnostic procedure.

Enrolling by invitation

Start Date:
2024-01-09

Close Date:
2025-11

Interventions:

OTHER: Stereoelectroencephalography (SEEG)

Enrolling by invitation

Start Date:
2024-01-09

Close Date:
2025-11

Interventions:

OTHER: Stereoelectroencephalography (SEEG)

ClinicalTrials.gov

A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

Brief Summary: The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Recruiting

Start Date:
2024-03-14

Close Date:
2026-12

Interventions:

DRUG: BHV-7000
DRUG: BHV-7000
DRUG: Placebo

Recruiting

Start Date:
2024-03-14

Close Date:
2026-12

Interventions:

DRUG: BHV-7000
DRUG: BHV-7000
DRUG: Placebo

ClinicalTrials.gov

Neonatal Seizures: Semiology, Etiology, Therapy and Prognosis Correlations

Brief Summary: Epileptic seizures in newborns (often called "neonatal convulsions") represent the most frequent neurological problem in newborns (1-3/1000 newborns). The type of seizure and their etiology is very varied and therefore the therapeutic protocol also requires adaptations with a personalization of the therapeutic approach according to the characteristics of the case according to principles of precision medicine in particular for forms of neonatal epilepsy compared to epileptic seizures acute symptomatic. In recent years it has been highlighted that the clinical characterization and instrumental characterization, in particular electroencephalographic, of epileptic seizures represents an important biomarker that allows the choice of therapy to be oriented appropriately. In the literature there is a lack of single-center studies that relate the type of crisis according to the new ILAE 2017 classification (Fisher 2017) and its proposal for neonatal adaptation (Pressler 2021) with the etiology, type of therapy and outcome neurological after a few years. The primary aim of the study is to evaluate the correlation between the type of seizure determined according to the ILAE classification (clinical variables), the EEG findings of the epileptic seizures and the specific etiology of the epileptic seizures. The secondary aim is to evaluate the correlation between seizure type and etiology with effective therapy, length of hospitalization and neurobehavioral development outcome. The study design is a retrospective observational on the population of neonates managed at our center in the last decade.

Active, not recruiting

Start Date:
2021-06-01

Close Date:
2024-07-01

Interventions:

OTHER: observational study

Active, not recruiting

Start Date:
2021-06-01

Close Date:
2024-07-01

Interventions:

OTHER: observational study

ClinicalTrials.gov

ESIS in Pediatric DRE

Brief Summary: The main reason for this research study is to gain information about how the brain makes seizures by causing seizures using very small amounts of current, or electrical stimulation. Using small amounts of current to cause seizures (or stimulate) is not new at CCHMC - it is part of routine clinical practice for some patients at some electrodes. This study differs from routine clinical care in that all study patients will undergo electrical stimulation in all or nearly all electrode contacts. The study team is doing this because there is promising data in adult patients that stimulating comprehensively (targeting all or nearly all of the electrode contacts) helps define the seizure network. Defining the seizure network in turn helps the medical team plan surgery. So far, there is not as much published data on seizure stimulation for pediatric patients. This research study thus has the potential both to help individual patients (by providing specific information about your seizure networks) and to help pediatric patients with epilepsy in general (by increasing our understanding of stimulated seizures in children, teenagers and young adults).

Recruiting

Start Date:
2022-02-17

Close Date:
2027-12-31

Recruiting

Start Date:
2022-02-17

Close Date:
2027-12-31

ClinicalTrials.gov

Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

Brief Summary: The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Recruiting

Start Date:
2024-05-13

Close Date:
2026-02

Interventions:

DRUG: BHV-7000
DRUG: BHV-7000
DRUG: Placebo

Recruiting

Start Date:
2024-05-13

Close Date:
2026-02

Interventions:

DRUG: BHV-7000
DRUG: BHV-7000
DRUG: Placebo

ClinicalTrials.gov

A Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety

Brief Summary: A Randomized, Multi-Center, Double-Blind, Sham-Procedure-Controlled Clinical Trial to Investigate the Efficacy and Safety of Elsunersen in Pediatric Participants with Early Onset SCN2A Developmental and Epileptic Encephalopathy

Recruiting

Start Date:
2025-08-13

Close Date:
2028-12

Interventions:

DRUG: 1mg elsunersen
PROCEDURE: sham procedure
DRUG: 0.5mg elsunersen

Recruiting

Start Date:
2025-08-13

Close Date:
2028-12

Interventions:

DRUG: 1mg elsunersen
PROCEDURE: sham procedure
DRUG: 0.5mg elsunersen

ClinicalTrials.gov

The Effect of Sleep Hygiene Given to Epilepsy Patients on Seizure Frequency and Sleep Quality

Brief Summary: Epilepsy is a disease that can be seen in everyone, including neurological, chronic, elderly and children. An estimated 50 million people in the world have epilepsy, patients have a history of two or more seizures, the exact cause is unknown, it negatively affects home, work and school life, and it directs individuals from their independent roles to semi-dependent and fully dependent roles (Smith \& Wagner \& Jonathan, 2015). "Neuronal networks hypersynchronization" develops epileptic seizures, can cause insomnia, and sleep quality may decrease with drug treatment (Sünter and Ağan, 2019). NREM sleep causes seizures through the "ictal and interactive effect" of sleep (Alp and Altındağ, 2014). Insomnia increases seizure discharges, neurological and systemic complications may develop, and serious morbidity and mortality may occur (Özer, 2005). Epilepsy patients frequently experience daytime sleepiness and nighttime insomnia (Gümüşyayla and Vural, 2017). Complementary medical approaches are also recommended along with drug treatment. Sleep hygiene training is recommended for sleep health in epilepsy as in chronic diseases. With good sleep health, symptoms can be eliminated and sequelae can be prevented by reducing epileptic discharges (Gammino at all., 2016). Quality sleep is essential for physiological and psychological health, and sleep disorders can be corrected with sleep hygiene training (Günaş, 2018). Randomized studies including sleep hygiene training are needed to prevent seizure recurrences, prevent or treat comorbid psychological diseases, and improve life activities of epilepsy patients (Lee at all., 2015). One-third of people's lives are spent in sleep, regular and adequate sleep protects physiological and psychological health, sleep hygiene training contributes to the recovery of sleep disorders and accompanying psychological comorbid diseases, sleep hygiene training is cost-free and easy to implement, where daily activities and behaviors are regulated, appropriate environmental conditions are provided. By regulating the circadian rhythm, melatonin is released during sleep at night and sleep disorders are prevented by preventing excessive cortisol release (http://www.psikiyatri.net/uyku-hijyeni / Access date: 28 May 2022; Alp and Altındağ, 2014; Güneş, 2018). . No research has been found on sleep hygiene training to relieve sleep deprivation, which is common in epilepsy patients. With good sleep hygiene, sleep and quality of life can be improved and epileptic seizures can be prevented or reduced. Purpose of the research; To determine the effect of sleep hygiene training given to epilepsy patients on seizure frequency and sleep quality. Non-drug clinical research is an experimentally planned research with a pre-test post-test control group trial model.

Active, not recruiting

Start Date:
2023-06-01

Close Date:
2024-12-01

Interventions:

BEHAVIORAL: Sleep Hygiene Training

Active, not recruiting

Start Date:
2023-06-01

Close Date:
2024-12-01

Interventions:

BEHAVIORAL: Sleep Hygiene Training

ClinicalTrials.gov

Monitoring Key Activity and Physiology of Neonates in Intensive Care

Brief Summary: To optimise and evaluate a novel non-contact physiological monitoring system in the neonatal intensive care unit (NICU)

Recruiting

Start Date:
2021-08-01

Close Date:
2026-12-31

Recruiting

Start Date:
2021-08-01

Close Date:
2026-12-31

ClinicalTrials.gov

Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring

Brief Summary: The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

Not yet recruiting

Start Date:
2024-01

Close Date:
2024-12

Not yet recruiting

Start Date:
2024-01

Close Date:
2024-12

ClinicalTrials.gov

Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies

Brief Summary: The Bonebridge (BB) is a partially implantable active transcutaneous bone conduction hearing system manufactured by MED-EL Elektromedizinische Geräte Gesellschaft m.b.H. (MED-EL, Innsbruck, Austria). The BB augments hearing by providing acoustic input to the inner ear via bone conduction. In 2017 Hodgetts \& Scollie introduced a new fitting algorithm called DSL-BCD. The DSL-BCD algorithm was developed especially for the characteristics of bone conduction devices (BCD). If there is a benefit on the patient level in hearing outcomes when comparing the application of DSL-BCD in comparison to DSL v5 when using the BB, was not yet investigated. The aim of this clinical study is to show the improvement in audiological performance and subjective satisfaction with the BCI602 and SAMBA 2 audio processor in patients with conductive hearing loss compared to the unaided condition and to evaluate performance differences through application of 2 different fitting algorithms, namely DSL v5 and DSL-BCD.

Recruiting

Start Date:
2023-06-27

Close Date:
2026-06-27

Interventions:

PROCEDURE: Fitting of the audioprocessor with the auditory implant BCI602

Recruiting

Start Date:
2023-06-27

Close Date:
2026-06-27

Interventions:

PROCEDURE: Fitting of the audioprocessor with the auditory implant BCI602

ClinicalTrials.gov

Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy

Brief Summary: The NSR-GENE study is a longitudinal cohort study of approximately 300 parent-child trios from the Neonatal Seizure Registry and participating site outpatient clinics that aims to evaluate whether and how genes alter the risk of post-neonatal epilepsy among children with acute provoked neonatal seizures. The researchers aim to develop prediction rules to stratify neonates into low, medium, and high risk for post-neonatal epilepsy based on clinical, electroencephalogram (EEG), magnetic resonance imaging (MRI), and genetic risk factors.

Recruiting

Start Date:
2022-08-09

Close Date:
2027-02-28

Recruiting

Start Date:
2022-08-09

Close Date:
2027-02-28

ClinicalTrials.gov

buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest

Brief Summary: RESTORE is a randomized clinical trial investigating the safety and feasibility of using EEG treatment targets (burst suppression vs. seizure suppression) for post-cardiac arrest refractory status epilepticus treatment.

Recruiting

Start Date:
2023-08-07

Close Date:
2027-04-30

Interventions:

DRUG: Burst Suppression EEG Target Intravenous Anesthesia
DRUG: Seizure Suppression EEG Target Intravenous Anesthesia

Recruiting

Start Date:
2023-08-07

Close Date:
2027-04-30

Interventions:

DRUG: Burst Suppression EEG Target Intravenous Anesthesia
DRUG: Seizure Suppression EEG Target Intravenous Anesthesia

ClinicalTrials.gov

Status Epilepticus Population Study (STEPS)

Brief Summary: The aim of this observational multicenter cohort study is to gain a deeper understanding regarding the effects of treatment adaption based on information from outcome prediction models, risk stratification, as well as treatment monitoring, detection, prevention, and management of complications on course and outcome of adult patients with status epilepticus (SE).

Recruiting

Start Date:
2019-04-19

Close Date:
2050-12

Interventions:

OTHER: collection of patient data

Recruiting

Start Date:
2019-04-19

Close Date:
2050-12

Interventions:

OTHER: collection of patient data

ClinicalTrials.gov

Infrared Photobiomodulation in Humans With Epilepsy

Brief Summary: Drug-resistant epilepsy represents roughly 40% of people with epilepsy. It is very challenging to stop seizures in this condition, and the treatment options are limited. This study aims to investigate a new treatment that involves using infra-red light. In animals, this treatment has shown promise as a possible way to reduce seizures, but it has not been tested in humans for this. The investigators are interested to know if it can reduce seizures, and how comfortable it is to be treated with this therapy.

Not yet recruiting

Start Date:
2025-11-25

Close Date:
2027-09-25

Interventions:

DEVICE: photobiomodulation

Not yet recruiting

Start Date:
2025-11-25

Close Date:
2027-09-25

Interventions:

DEVICE: photobiomodulation

ClinicalTrials.gov

Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)

Brief Summary: SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.

Recruiting

Start Date:
2023-03-01

Close Date:
2028-12-31

Recruiting

Start Date:
2023-03-01

Close Date:
2028-12-31

ClinicalTrials.gov

Adjunctive Anti-seizure Medication (ASM) Real World Evidence (RWE) Study

Brief Summary: The purpose of this study is to describe the effectiveness of the adjunctive ASM treatment on the clinical response, safety profile and quality of life of patients affected by focal onset seizures in a real-world setting.

Active, not recruiting

Start Date:
2023-05-02

Close Date:
2025-09-30

Interventions:

OTHER: ASM as adjunctive therapy

Active, not recruiting

Start Date:
2023-05-02

Close Date:
2025-09-30

Interventions:

OTHER: ASM as adjunctive therapy

ClinicalTrials.gov

Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting

Brief Summary: Main objective: Compare speech recognition in noise with tonotopic fitting (FS4T) and with conventional non-tonotopic fitting (FS4noT) in adult patients implanted for 6 months with a MED-EL cochlear implant with FS4noT strategy. Secondary objectives: Comparison of FS4noT and FS4T settings * for speech recognition in quiet * for subjective auditory spatial perception

Recruiting

Start Date:
2025-01-01

Close Date:
2028-06-30

Interventions:

OTHER: Tonotopic cochlear implant fitting FS4T

Recruiting

Start Date:
2025-01-01

Close Date:
2028-06-30

Interventions:

OTHER: Tonotopic cochlear implant fitting FS4T

ClinicalTrials.gov

Multimodal Neuromonitoring

Brief Summary: Theoretical Framework \& Background Cortical spreading depressions (CSD) and seizures, are crucial in the development of delayed cerebral ischemia and poor functional outcome in patients suffering from acute brain injuries such as subarachnoid hemorrhage. Multimodal neuromonitoring (MMNM) provides the unique possibility in the sedated and mechanically ventilated patients to record these electrophysiological phenomena and relate them to measures of cerebral ischemia and malperfusion. MMNM combines invasive (e.g. electrocorticography, cerebral microdialysis, brain tissue oxygenation) and noninvasive (e.g. neuroimaging, continuous EEG) techniques. Additionally, cerebral microdialysis can measure the unbound extracellular drug concentrations of sedatives, which potentially inhibit CSD and seizures in various degrees, beyond the blood-brain barrier without further interventions. Hypotheses 1. Online multimodal neuromonitoring can accurately detect changes in neuronal metabolic demand and pathological neuronal bioelectrical changes in highly vulnerable brain tissue. 2. Online multimodal neuromonitoring can accurately detect the impact of pathological neuronal bioelectrical changes on metabolic demand in highly vulnerable brain tissue. 3. The occurrence and duration of pathological neuronal bioelectrical changes are dependent on sedatives and antiepileptic drug concentrations 4. The occurrence and duration of pathological neuronal bioelectrical changes have a negative impact on functional and neurological long-term patient outcome. 5. Simultaneous invasive and non-invasive multimodal neuromonitoring can identify a clear relationship of both methods regarding pathological neuronal bioelectrical changes and metabolic brain status. Methods Systematic analysis of MMNM measurements following standardized criteria and correlation of electrophysiological phenomena with cerebral metabolic changes in all included patients. In a second step neuroimaging, cerebral extracellular sedative drug concentrations and neurological functional outcome, will be correlated with both electrophysiologic and metabolic changes. Due to numerous high-resolution parameters, machine learning algorithms will be used to correlate comprehensive data on group and individual levels following a holistic approach. Level of originality Extensive, cutting edge diagnostic methods are used to get a better insight into the pathophysiology of electrophysiological and metabolic changes during the development of secondary brain damage. Due to the immense amount of high-resolution data, a computer-assisted evaluation will be applied to identify relationships in the development of secondary brain injury. For the first time systematic testing of several drug concentrations beyond the blood-brain barrier will be performed. With these combined methods, we will be able to develop new cerebroprotective treatment concepts on an individual basis.

Recruiting

Start Date:
2020-12-01

Close Date:
2025-12-01

Recruiting

Start Date:
2020-12-01

Close Date:
2025-12-01

ClinicalTrials.gov

Does Levetiracetam and Carbamazepine Impact the Autonomic Activity of Children With Self-limiting Focal Epilepsy?

Brief Summary: The goal of this cross-sectional study is to learn about autonomic cardiac profile changes in children with self-limiting focal epilepsy using levetiracetam and carbamazepine in children with self-limiting focal epilepsy syndrome. The main questions is it aims to answer are: 1. Are heart rate variability and autonomic tone different among healthy controls and children with epilepsy? 2. Does Levetiracetam and carbamazepine affect autonomic tone differently among children with self-limiting focal epilepsy?

Active, not recruiting

Start Date:
2023-01-01

Close Date:
2023-12-02

Interventions:

DIAGNOSTIC_TEST: electroencephalogram

Active, not recruiting

Start Date:
2023-01-01

Close Date:
2023-12-02

Interventions:

DIAGNOSTIC_TEST: electroencephalogram

ClinicalTrials.gov

Cenobamate Expanded Access Program (EAP)

Brief Summary: This Cenobamate Expanded Access Program (EAP) is designed to continue providing treatment with Cenobamate (YKP3089) to patients with partial-onset epilepsy that were enrolled in the SK Life Science clinical trial YKP3089C013, YKP3089C017 or YKP3089C021.

Approved for marketing

Start Date:

Close Date:

Interventions:

DRUG: YKP3089

Approved for marketing

Start Date:

Close Date:

Interventions:

DRUG: YKP3089

ClinicalTrials.gov

Predisposing Factors for Post-stroke Epilepsy

Brief Summary: The goal of this observational study is to learn about epilepsy after a stroke (post-stroke epilepsy). The main questions it aims to answer are: * What make some patients develop epilepsy after a stroke? * Does sleep have an impact on the development of post-stroke epilepsy? Participants will undergo: * Electroencephalography (EEG) * Magnetic resonance imaging (MRI) * Polysomnography (only patients) Blood tests will also be taken. The patient group will be compared to the healthy controls. Researchers will also look into medical records of stroke patients hospitalized at St. Olavs hospital and collect relevant information.

Recruiting

Start Date:
2023-05-08

Close Date:
2030-12

Recruiting

Start Date:
2023-05-08

Close Date:
2030-12

ClinicalTrials.gov

Human Epilepsy Genetics--Neuronal Migration Disorders Study

Brief Summary: The purpose of this study is to identify genes responsible for epilepsy, brain malformations and disorders of human cognition.

Recruiting

Start Date:
1996-04

Close Date:
2030-06

Recruiting

Start Date:
1996-04

Close Date:
2030-06

ClinicalTrials.gov

A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome

Brief Summary: ENDEAVOR is a Phase 1/2, 2-part, multicenter study to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet syndrome aged ≥6 to \<36 months (Part 1) and aged ≥6 to \<48 months (Part 2). Part 1 follows an open-label, dose-escalation design, and Part 2 is a randomized, double-blind, sham delayed-treatment control, dose-selection study.

Recruiting

Start Date:
2024-05-14

Close Date:
2031-04

Interventions:

DRUG: ETX101

Recruiting

Start Date:
2024-05-14

Close Date:
2031-04

Interventions:

DRUG: ETX101

ClinicalTrials.gov

Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation (ECLIPSE)

Brief Summary: The occurrence of seizures in epilepsy is not entirely random. Temporal patterns that organize the occurrence of seizures over weeks and months were previously unraveled using intracranial EEG System (IEEG) that monitors epileptic brain activity chronically. Seizures typically recur with patient-specific periodicity and are preceded by increases of epileptic brain activity over days. Here, the investigators developed new methods to forecast seizure likelihoods at a 24-h horizon. In this trial, participants will be provided with daily estimates about their upcoming risk of seizures. As a primary outcome, the performance of forecasts will be evaluated against the occurrence of electrographic seizures. As secondary outcome, the forecast's potential benefit for users in conveying actionable information in real-life will be assessed.

Enrolling by invitation

Start Date:
2025-05-01

Close Date:
2028-12-31

Interventions:

OTHER: Seizure risk forecast
OTHER: Control seizure risk forecast

Enrolling by invitation

Start Date:
2025-05-01

Close Date:
2028-12-31

Interventions:

OTHER: Seizure risk forecast
OTHER: Control seizure risk forecast

ClinicalTrials.gov

Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Drug-resistant Epilepsy

Brief Summary: The goal of the real-world study is to evaluate the long-term seizure control outcomes, postoperative complications, long term impact on cognitive, memory function outcomes, quality-of-life measures, and healthcare resource utilization of magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) on patients with drug-resistant epilepsy (DRE).

Enrolling by invitation

Start Date:
2024-03-14

Close Date:
2026-03-14

Interventions:

DEVICE: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)

Enrolling by invitation

Start Date:
2024-03-14

Close Date:
2026-03-14

Interventions:

DEVICE: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)

ClinicalTrials.gov

Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)

Brief Summary: Rationale/gaps in existing knowledge: The prophylaxis for post-traumatic seizures (PTS) remains controversial due to a lack of class I evidence. Investigators plan to conduct a high-quality, prospective, multicentric, randomized study regarding seizure prophylaxis in traumatic brain injury (TBI) with phenytoin, levetiracetam, and the placebo in three respective treatment groups, along with the effect of drug polymorphism on seizure occurrence. Novelty: Literature is scarce regarding the ideal management of early PTS in traumatic brain injury (TBI), a major public health problem. Further, no study has evaluated the effect of genetic polymorphism on seizure occurrence in traumatic brain injury. This Multicentric study will be the first of its kind, not only in India but also globally. Objectives: To evaluate the seizure incidence \& efficacy of the respective anti-epileptic drug in each treatment arm. Assessment of clinical \& functional outcomes, safety profile, and cost-effectiveness in each group. Effect of genetic polymorphisms on seizure incidence among study participants Methods: A Multicentric prospective randomized placebo-controlled double-blinded clinical trial is planned. After satisfying eligibility criteria and informed consent, TBI patients will be randomly allocated into three arms 'phenytoin arm', 'levetiracetam arm', and 'placebo'. Drug polymorphism will be analyzed in all the patients using quantitative real-time PCR. Expected outcome: This study will provide high-quality evidence in PTS management and will establish the role of prophylactic anti-epileptics in PTS. This study also opens the plethora of undesignated roles of genetic polymorphism in the efficacy and safety of levetiracetam and phenytoin in traumatic brain injury patients.

Recruiting

Start Date:
2025-07-23

Close Date:
2028-03-15

Interventions:

DRUG: Phenytoin
DRUG: Levetiracetam
DRUG: Placebo

Recruiting

Start Date:
2025-07-23

Close Date:
2028-03-15

Interventions:

DRUG: Phenytoin
DRUG: Levetiracetam
DRUG: Placebo

ClinicalTrials.gov

A Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures

Brief Summary: This study will compare the effect of NPT 2042 and placebo in subjects with GGE on the frequency and duration of electroencephalographic absence seizures, separated by a 14-day washout period. The study will be a single-center, double-blind, crossover study with subjects receiving either NPT 2042 80 mg BID orally or matching placebo BID in each of two treatment periods.

Recruiting

Start Date:
2025-03-11

Close Date:
2026-05-30

Interventions:

DRUG: NPT 2042
OTHER: Placebo

Recruiting

Start Date:
2025-03-11

Close Date:
2026-05-30

Interventions:

DRUG: NPT 2042
OTHER: Placebo

ClinicalTrials.gov

HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE)

Brief Summary: The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-PTE, to improve the quality of life and cognitive function in Service Members, Veterans and civilians with post traumatic epilepsy (PTE). This study will also assess the ability of the HOBSCOTCH-PTE program to improve quality of life in caregivers of PTE patients and to reduce caregiver burden.

Active, not recruiting

Start Date:
2022-03-21

Close Date:
2025-12

Interventions:

BEHAVIORAL: Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)
BEHAVIORAL: HOBSCOTCH-PTE for Caregivers

Active, not recruiting

Start Date:
2022-03-21

Close Date:
2025-12

Interventions:

BEHAVIORAL: Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)
BEHAVIORAL: HOBSCOTCH-PTE for Caregivers

ClinicalTrials.gov

Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients

Brief Summary: In this study, the investigators propose Pulsed Low-Intensity Focused Ultrasound (PLIFU) stimulation of brain regions that modulate (thalamus) or generate focal motor seizures (primary motor cortex), with the goal of ameliorating seizure activity in subjects in non-convulsive or focal motor status epilepticus. The course of treatment will consist of an initial 10 minute PLIFU treatment session with an option for a 2nd session if necessary. The primary objective of this study is to determine whether PLIFU reduces or suppresses epileptic activity in patients with Non-Convulsive Status Epilepticus (NCSE)/Focal Motor Status Epilepticus (FMSE) that have not responded to standard of care.

Recruiting

Start Date:
2023-06-24

Close Date:
2026-02

Interventions:

DEVICE: PLIFU

Recruiting

Start Date:
2023-06-24

Close Date:
2026-02

Interventions:

DEVICE: PLIFU

ClinicalTrials.gov

Retraining and Control Therapy (ReACT) R33 Phase

Brief Summary: The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no correlated epileptiform activity). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of either ReACT or supportive therapy. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C), pain tolerance (time with hand in water) and cortisol response. Target assessments occur 7 days before treatment, 7 days after 12th treatment session, and 2 months after the 12th treatment session. Long term follow-up assessments will occur 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment.

Recruiting

Start Date:
2024-03-09

Close Date:
2026-08-31

Interventions:

BEHAVIORAL: ReACT
BEHAVIORAL: Supportive Therapy

Recruiting

Start Date:
2024-03-09

Close Date:
2026-08-31

Interventions:

BEHAVIORAL: ReACT
BEHAVIORAL: Supportive Therapy

ClinicalTrials.gov

Incidence of Metabolic Disorders in Neonatal Convulsions

Brief Summary: Describe the incidence of metabolic disorders in neonatal convulsions affecting neonates at NICU Describe types of metabolic disorders causing neonatal convulsions

Not yet recruiting

Start Date:
2023-11-25

Close Date:
2025-02-25

Interventions:

DEVICE: MRI

Not yet recruiting

Start Date:
2023-11-25

Close Date:
2025-02-25

Interventions:

DEVICE: MRI

ClinicalTrials.gov

Effect of Early Prosthetic Fitting in Patients With Below-knee Amputation

Brief Summary: A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation. Delayed rehabilitation may cause severe physical complications like joint contracture, and muscle strength loss.

Active, not recruiting

Start Date:
2023-11-01

Close Date:
2024-10-30

Interventions:

BEHAVIORAL: Early Rehab Group
OTHER: Delayed Rehab Group

Active, not recruiting

Start Date:
2023-11-01

Close Date:
2024-10-30

Interventions:

BEHAVIORAL: Early Rehab Group
OTHER: Delayed Rehab Group

ClinicalTrials.gov

Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

Brief Summary: The purpose of this study is to assess the incidence of early post-traumatic seizures. The study will also assess the benefit of lacosamide compared to levetiracetam in regards to agitation and behavioral adverse effects in patients with moderate to severe traumatic brain injury requiring seizure prophylaxis.

Recruiting

Start Date:
2025-04-18

Close Date:
2026-04

Interventions:

DRUG: levetiracetam
DRUG: lacosamide

Recruiting

Start Date:
2025-04-18

Close Date:
2026-04

Interventions:

DRUG: levetiracetam
DRUG: lacosamide

ClinicalTrials.gov

Pediatric Dose Optimization for Seizures in Emergency Medical Services

Brief Summary: The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study is designed to improve how paramedics treat seizures in children on ambulances. Seizures are one of the most common reasons why people call an ambulance for a child, and paramedics typically administer midazolam to stop the seizure. One-third of children with active seizures on ambulances arrive at emergency departments still seizing. Prior research suggests that seizures on ambulances continue due to under-dosing and delayed delivery of medication. Under-dosing happens when calculation errors occur, and delayed medication delivery occurs due to the time required for dose calculation and placement of an intravenous line to give the medication. Seizures stop quickly when standardized medication doses are given as a muscular injection or a nasal spray. This research has primarily been done in adults, and evidence is needed to determine if this is effective and safe in children. PediDOSE optimizes how paramedics choose the midazolam dose by eliminating calculations and making the dose age-based. This study involves changing the seizure treatment protocols for ambulance services in 20 different cities, in a staggered and randomly-assigned manner. One aim of PediDOSE is to determine if using age to select one of four standardized doses of midazolam and giving it as a muscular injection or nasal spray is more effective than the current calculation-based method, as measured by the number of children arriving at emergency departments still seizing. The investigators believe that a standardized seizure protocol with age-based doses is more effective than current practice. Another aim of PediDOSE is to determine if a standardized seizure protocol with age-based doses is just as safe as current practice, since either ongoing seizures or receiving too much midazolam can interfere with breathing. The investigators believe that a standardized seizure protocol with age-based doses is just as safe as current practice, since the seizures may stop faster and these doses are safely used in children in other healthcare settings. If this study demonstrates that standardized, age-based midazolam dosing is equally safe and more effective in comparison to current practice, the potential impact of this study is a shift in the treatment of pediatric seizures that can be easily implemented in ambulance services across the United States and in other parts of the world.

Recruiting

Start Date:
2022-08-08

Close Date:
2026-09-30

Interventions:

DRUG: Standardized seizure protocol
DRUG: Conventional seizure protocol

Recruiting

Start Date:
2022-08-08

Close Date:
2026-09-30

Interventions:

DRUG: Standardized seizure protocol
DRUG: Conventional seizure protocol

ClinicalTrials.gov

Multicenter Comparison of Interictal HFO as a Predictor of Seizure Freedom

Brief Summary: In drug-resistant focal epilepsy, interictal high frequency oscillations (HFO) recorded from intracranial EEG (iEEG) may provide clinical information for delineating epileptogenic brain tissue. The iEEG electrode contacts that contain HFO are hypothesized to delineate the epileptogenic zone; their resection should then lead to postsurgical seizure freedom. We test whether our prospective definition of clinically relevant HFO is in agreement with postsurgical seizure outcome. The algorithm is fully automated and is equally applied to all datasets. The aim is to assess the reliability of the proposed detector and analysis approach.

Enrolling by invitation

Start Date:
2022-05-01

Close Date:
2024-05-01

Interventions:

DIAGNOSTIC_TEST: HFO analysis

Enrolling by invitation

Start Date:
2022-05-01

Close Date:
2024-05-01

Interventions:

DIAGNOSTIC_TEST: HFO analysis

ClinicalTrials.gov

Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1

Brief Summary: The primary purpose of the study is to understand the effectiveness, safety, and tolerability of encaleret when compared to standard of care (SoC) treatment in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).

Active, not recruiting

Start Date:
2023-01-06

Close Date:
2029-08

Interventions:

DRUG: Encaleret
DIETARY_SUPPLEMENT: Standard of Care

Active, not recruiting

Start Date:
2023-01-06

Close Date:
2029-08

Interventions:

DRUG: Encaleret
DIETARY_SUPPLEMENT: Standard of Care

ClinicalTrials.gov

Electrographic Seizure Management and Neurobehavioral Outcomes in Critically Ill Children

Brief Summary: Electrographic seizures are common in critically ill patients leading to increased use of resource-intense continuous EEG monitoring for seizure identification and management. When identified, electrographic seizures are generally treated with anti-seizure medications, but there are very limited data available regarding optimal treatment in terms of the efficacy or safety of specific anti-seizure medications or overall management strategies. This is a single-center prospective observational study. The investigators aim to: (1) track critically ill patients undergoing clinically indicated EEG monitoring and seizure management to identify risk factors for electrographic seizures, (2) create prediction models guiding EEG monitoring resources to the patients at highest risk for seizures, and (3) evaluate our current management strategy in terms of safety.

Recruiting

Start Date:
2017-03-13

Close Date:
2027-01-01

Interventions:

OTHER: Clinically indicated EEG monitoring.

Recruiting

Start Date:
2017-03-13

Close Date:
2027-01-01

Interventions:

OTHER: Clinically indicated EEG monitoring.

ClinicalTrials.gov

Magnetic Seizure Therapy in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD)

Brief Summary: The purpose of this study is to compare the efficacy and side effects magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD).

Recruiting

Start Date:
2025-03-01

Close Date:
2025-12-30

Interventions:

DEVICE: magnetic seizure therapy (MST)
DEVICE: electroconvulsive therapy (ECT)

Recruiting

Start Date:
2025-03-01

Close Date:
2025-12-30

Interventions:

DEVICE: magnetic seizure therapy (MST)
DEVICE: electroconvulsive therapy (ECT)

ClinicalTrials.gov

ADH1 and ADH2 Disease Monitoring Study (DMS)

Brief Summary: A global, multi-center, Disease Monitoring Study (DMS) in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1) or Autosomal Dominant Hypocalcemia Type 2 (ADH2) designed to characterize ADH1 and ADH2 disease presentation and progression through retrospective (past) and longitudinal prospective (over time into the future) data collection.

Active, not recruiting

Start Date:
2022-01-20

Close Date:
2028-12

Active, not recruiting

Start Date:
2022-01-20

Close Date:
2028-12

ClinicalTrials.gov

A Study to Assess utiLity of BIoEP as an Early Prognostic Indicator for Predicting Anti-Seizure Medication (ASM) Efficacy

Brief Summary: This multisite prospective clinical study is to investigate the relationship between seizure type and frequency with the BioEP result during ASM titration in newly diagnosed patients with epilepsy, and to assess the utility of BioEP as an early prognostic indicator of ASM efficacy

Not yet recruiting

Start Date:
2024-09

Close Date:
2027-06

Not yet recruiting

Start Date:
2024-09

Close Date:
2027-06

ClinicalTrials.gov

A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures

Brief Summary: The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.

Recruiting

Start Date:
2024-06-20

Close Date:
2027-07

Interventions:

DRUG: BHV-7000
DRUG: Placebo

Recruiting

Start Date:
2024-06-20

Close Date:
2027-07

Interventions:

DRUG: BHV-7000
DRUG: Placebo

ClinicalTrials.gov

RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults with Focal Onset Seizures

Brief Summary: This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 in adults with focal onset seizures.

Recruiting

Start Date:
2024-12-30

Close Date:
2026-10

Interventions:

DRUG: SPN-817
DRUG: Placebo

Recruiting

Start Date:
2024-12-30

Close Date:
2026-10

Interventions:

DRUG: SPN-817
DRUG: Placebo

ClinicalTrials.gov

A Study of the Effectiveness of Risk Minimization Measures Related to Depakine® (Sodium Valproate) in Saudi Arabia

Brief Summary: A cross-sectional, national, multicenter, survey-based study to assess the effectiveness of Risk Minimization Measures related to Depakine® (sodium valproate) in Saudi Arabia. The end of study is defined as the end of the data collection period. No intervention will be administered, and no study related visits are required.

Active, not recruiting

Start Date:
2025-04-29

Close Date:
2025-11-27

Interventions:

DRUG: Sodium valporate

Active, not recruiting

Start Date:
2025-04-29

Close Date:
2025-11-27

Interventions:

DRUG: Sodium valporate

ClinicalTrials.gov

A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Brief Summary: The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.

Enrolling by invitation

Start Date:
2022-02-03

Close Date:
2028-11-30

Interventions:

DRUG: Staccato alprazolam

Enrolling by invitation

Start Date:
2022-02-03

Close Date:
2028-11-30

Interventions:

DRUG: Staccato alprazolam

ClinicalTrials.gov

Study of Direct Brain Recording and Stimulation for Memory Enhancement

Brief Summary: Background: \- Epilepsy is a seizure disorder. Sometimes it is treated with surgery. During surgery, electrodes are placed on or in the brain. Researchers want to learn more about memory and the brain. They want to do tests on people who are having epilepsy surgery. Objective: \- To learn more about memory and brain function by recording brain cell activity during memory tasks. Eligibility: \- Adults age 18 - 65 who have medically intractable epilepsy and will have electrodes placed to identify the source of their seizures. They must be currently enrolled in protocol 11-N-0051. Design: * Participants may do memory tests before the electrodes are put in, while they are in place, and after surgery. Researchers may stimulate areas of the brain with small pulses of electricity. * Researchers will start recording brain activity at least 12 hours after electrodes are placed. They will record while participants are awake and asleep. They will record before, during, and after seizures. * Participants may have up to 3 testing sessions daily over the 1-3 weeks the electrodes are in place. Each session will last 20-60 minutes. * Participants will play games on a laptop. Sometimes they may use a button or joystick. This can be done in bed in the hospital. * Participants may be given a list of words and asked to recall them in a short time. * Participants may be given pairs of items and asked to remember how they are related. * Participants may be asked to learn their way around a virtual town on the computer. Their eye movements may be tracked by a small camera.

Enrolling by invitation

Start Date:
2016-10-28

Close Date:
2026-01-01

Enrolling by invitation

Start Date:
2016-10-28

Close Date:
2026-01-01

ClinicalTrials.gov

Simulation Trial of Telemedical Support for Paramedics

Brief Summary: In the United States, the current standard of prehospital (i.e. outside of hospitals) emergency care for children with life-threatening illnesses in the community includes remote physician support for paramedics providing life-saving therapy while transporting the child to the hospital. Most prehospital emergency medical services (EMS) agencies use radio-based (audio only) communication between paramedics and physicians to augment this care. However, this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment. The purpose of this pilot randomized controlled trial (RCT) is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life threatening illness (respiratory failure). Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. Because real pediatric life-threatening illnesses are rare, high stakes events and involve a vulnerable population (children), this RCT will test the effect of the intervention on paramedic performance in simulated cases of pediatric medical emergencies. The two specific aims for this research are: * Aim 1: To test the intervention efficacy by determining if there is a measurable difference in the frequency of serious safety events between study groups * Aim 2: To compare two safety event detection methods, medical record review, and video review

Recruiting

Start Date:
2025-07-10

Close Date:
2028-12

Interventions:

OTHER: Video teleconsultation
OTHER: Audio support

Recruiting

Start Date:
2025-07-10

Close Date:
2028-12

Interventions:

OTHER: Video teleconsultation
OTHER: Audio support

ClinicalTrials.gov

Thermocoagulation in Drug Resistant Focal Epilepsy

Brief Summary: Therapeutic thermocoagulation will be carried out in patients with drug-resistant focal epilepsy in cases where an epileptogenic zone is found and proven according to stereo-electroencephalography (SEEG) data.

Active, not recruiting

Start Date:
2022-02-07

Close Date:
2024-12-01

Interventions:

PROCEDURE: Radiofrequency thermocoagulation

Active, not recruiting

Start Date:
2022-02-07

Close Date:
2024-12-01

Interventions:

PROCEDURE: Radiofrequency thermocoagulation

ClinicalTrials.gov

Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization

Brief Summary: Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization. Secondary objectives: Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS for the auditory skills experienced by the subject.

Recruiting

Start Date:
2023-10-17

Close Date:
2025-12-15

Interventions:

DEVICE: ABFnoS then ABFS (Cochlear implant)
DEVICE: ABFS then ABFnoS (Cochlear implant)

Recruiting

Start Date:
2023-10-17

Close Date:
2025-12-15

Interventions:

DEVICE: ABFnoS then ABFS (Cochlear implant)
DEVICE: ABFS then ABFnoS (Cochlear implant)

ClinicalTrials.gov

International Post-Stroke Epilepsy Research Repository

Brief Summary: The International Post-Stroke Epilepsy Research Repository (IPSERR): The study aims to collate and categorize data reported by post-stroke epilepsy (PSE) researchers and lodge it within the IPSERR. Using the IPSERR database, we will conduct two individual patient data (IPD) analyses: (1) determine epilepsy, functional, and cognitive outcomes in stroke patients who develop post-stroke seizure and (2) build and validate post-stroke epilepsy prediction model and compare performance against existing models.

Enrolling by invitation

Start Date:
2024-03-01

Close Date:
2029-12

Interventions:

OTHER: Presence of stroke, either ischemic or hemorrhagic (intracerebral and subarachnoid)

Enrolling by invitation

Start Date:
2024-03-01

Close Date:
2029-12

Interventions:

OTHER: Presence of stroke, either ischemic or hemorrhagic (intracerebral and subarachnoid)

ClinicalTrials.gov

Enhancing Scleral Lens Fit With Advanced Imaging

Brief Summary: The goal of this experimental clinical trial is to enhance the predictability and precision of scleral lens fitting in patients with complex corneal conditions such as keratoconus, post-surgical irregularities, and severe dry eye syndrome. The main questions it aims to answer are: Can detailed sagittal height measurements obtained from the Oculus Pentacam Corneal Scleral Profile (CSP) predict the necessary adjustments for optimal scleral lens fit? Will the use of these measurements reduce the number of trial-and-error adjustments needed to achieve an ideal fit, thereby reducing chair time and improving patient satisfaction? Participants will: Undergo detailed corneal and scleral tomography using the Oculus Pentacam with the CSP strategy. Receive customized ICD 16.5 mm scleral lenses based on precise measurements of their ocular surface. Participate in follow-up assessments to evaluate the fit of the lenses and provide feedback on comfort and visual outcomes. This study focuses on a specific participant population of adults aged 18 and older who have not had success with other types of contact lenses. By leveraging advanced imaging technologies, the research aims to streamline the fitting process for scleral lenses, potentially setting new standards for treatment efficacy in specialty contact lens practices.

Enrolling by invitation

Start Date:
2024-12-01

Close Date:
2024-12-31

Enrolling by invitation

Start Date:
2024-12-01

Close Date:
2024-12-31

ClinicalTrials.gov

Accelerated TMS for Seizure-Type Functional Neurologic Disorders

Brief Summary: The purpose of this project is to assess the feasibility, tolerability, and preliminary efficacy of using an accelerated, intermittent theta burst stimulation (a-iTBS-rTMS) protocol targeting the left dorsolateral prefrontal cortex (l-dlPFC) for Psychogenic Non-Epileptic Seizures (PNES) or Seizure-Type Functional Neurologic Disorder (FND-seiz) in an open-label fashion. Following screening, consent, and enrollment, participants will receive 6-to-10 iTBS-rTMS sessions per day (i.e., theta burst; 600 pulses per session; 6000 pulses per day) over a 3-to-5 treatment days with a target of 30 total sessions (18,000 total pulses). TMS will be targeted to Beam F3 for comparison to the bulk of the literature and to most mimic replicable and clinical use. This proposed iTBS-rTMS protocol was chosen given its previously shown safety, tolerability, and effectiveness in other conditions, but also as it has the potential to shorten treatment to only 3 days, which investigators theorize will be more feasible for patients with FND-seiz. Feasibility will be measured as the percentage of participants who receive at least 20 treatment sessions within the 3-to-5-day window. Other than self-assessments used in the safety screening process or to monitor TMS benefits and risks, secondary subjective measures will assess previously investigated FND-seiz-specific outcomes, which will be obtained prior to intervention and 4-weeks post-intervention. In addition to monthly seizure frequency, this will include validated measures regarding stigma, health-related QOL, depression, PTSD, somatic symptoms, psychosocial functioning, psychological distress, and clinical and participant impression of improvement and satisfaction. Sub-analysis will further divide participants with mild to no depression and/or PTSD versus moderate to severe depression and/or PTSD to further assess how the TMS effects known to effect other highly comorbid disorders with FND-seiz, may indirectly affect FND-seiz outcomes.

Recruiting

Start Date:
2025-09-02

Close Date:
2027-07-01

Interventions:

DEVICE: Transcranial Magnetic Stimulation

Recruiting

Start Date:
2025-09-02

Close Date:
2027-07-01

Interventions:

DEVICE: Transcranial Magnetic Stimulation

ClinicalTrials.gov

Honeycomb: Evaluation of Radiprodil in Children with GRIN-related Disorder

Brief Summary: Study RAD-GRIN-101 is a phase 1B trial to assess safety, tolerability, PK, and potential efficacy of radiprodil for the treatment of GRIN-related disorder in children with a Gain-of-Function (GoF) genetic variant. The study is open-label, so all participants will be treated with radiprodil. Subjects' participation in the study is expected to last up to six months in Part A. After the end of part A, all participants who are still eligible can choose to continue to receive radiprodil as part of an open-label long-term treatment period (Part B).

Active, not recruiting

Start Date:
2023-03-07

Close Date:
2026-11

Interventions:

DRUG: Radiprodil

Active, not recruiting

Start Date:
2023-03-07

Close Date:
2026-11

Interventions:

DRUG: Radiprodil

ClinicalTrials.gov

A Prospective Diagnostic Belief Updating Study to verIfy the Utility of BioEP in First Seizure Clinics.

Brief Summary: The goal of this belief updating study is to assess the utility of BioEP as a complementary support tool in aiding clinical decision making in adults in first seizure clinics. The main outcomes we shall measure are: * Clinicians' perception of seizure probability. * Clinicians' decision to recommend commencing or deferring ASM (anti-seizure medications) * Clinicians' decision to refer for additional investigations/services. Participants will consent to have their EEG (that is taken at their routine care) to be used in the study. There is not extra burden to the participants taking part in the study.

Active, not recruiting

Start Date:
2023-08-23

Close Date:
2025-09

Interventions:

DEVICE: BioEP

Active, not recruiting

Start Date:
2023-08-23

Close Date:
2025-09

Interventions:

DEVICE: BioEP

ClinicalTrials.gov

Acute Sympotomatic Seizure Secondary to Autoimmune Encephalitis and Autoimmune-associated Epilepsy

Brief Summary: Previously, scholars called the seizures secondary to autoimmune encephalitis（AE） "autoimmune related epilepsy", but the seizures secondary to AE are usually controlled after the improvement of encephalitis, which does not meet the "persistent" characteristics of epilepsy. Only a subset of patients with seizures lasting several years require long-term Antiseizure medications (ASM). In 2020, the International Coalition against Epilepsy classified it as "acute symptomatic seizure secondary to AE". ASSAE) and autoimmune-associated epilepsy (AAE) . The former is caused by AE, which has clinical manifestations of AE at the same time as epileptic seizures at the beginning or recurrence. The proportion and type of epileptic seizures are different due to different causes, and epileptic seizures are also controlled after the disease is controlled. The latter is that after adequate immunotherapy, there are still persistent seizures, and there is no obvious evidence of inflammatory activity, this type of patient application ASM and immunotherapy is not effective. Secondly, with the deepening of AE research, gradually found that some AAE can still be ASMs cure, such as carbamazepine, ocasepine, lakaosamine. On the one hand, it works by influencing cellular and humoral immune responses. On the other hand, effectiveness of sodium channel blockers in focal epilepsy. Lacosamide is a slow sodium channel blocker that belongs to the third generation of ASM. It has a short half-life and can be quickly increased to an effective dose with a low incidence of adverse reactions. Therefore, the investigators chose to add oral antiepileptic therapy with lacosamide in AAE populations to observe efficacy and safety.

Enrolling by invitation

Start Date:
2018-01-01

Close Date:
2025-12-31

Interventions:

DRUG: Lacosamide

Enrolling by invitation

Start Date:
2018-01-01

Close Date:
2025-12-31

Interventions:

DRUG: Lacosamide

ClinicalTrials.gov

Exogenous Ketone Esters for Refractory Status Epileptics

Brief Summary: This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus

Recruiting

Start Date:
2023-01-10

Close Date:
2025-07-01

Interventions:

DRUG: Exogenous ketone ester

Recruiting

Start Date:
2023-01-10

Close Date:
2025-07-01

Interventions:

DRUG: Exogenous ketone ester

ClinicalTrials.gov

Ear-Seizure Detection (EarSD) Study

Brief Summary: The proposed study is an investigator-initiated study that aims to measure the accuracy of a wearable seizure detection and prediction device (Ear-Seizure Detection Device (EarSD)) by simultaneous recording with conventional video-EEG (Electroencephalogram) on patients with epileptic seizures in the Epilepsy Monitoring Unit of the hospital.

Recruiting

Start Date:
2025-04-03

Close Date:
2032-12

Interventions:

DEVICE: Ear-SD
DIAGNOSTIC_TEST: Electroencephalogram

Recruiting

Start Date:
2025-04-03

Close Date:
2032-12

Interventions:

DEVICE: Ear-SD
DIAGNOSTIC_TEST: Electroencephalogram

ClinicalTrials.gov

Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking

Brief Summary: The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy. The main questions it aims to answer are: * can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables. * does this tool improve the lives of people with epilepsy? Researchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life.

Recruiting

Start Date:
2024-04-11

Close Date:
2026-06

Interventions:

DEVICE: SeizureWise algorithm
DEVICE: Multi-day Visualizations

Recruiting

Start Date:
2024-04-11

Close Date:
2026-06

Interventions:

DEVICE: SeizureWise algorithm
DEVICE: Multi-day Visualizations

ClinicalTrials.gov

A Multicenter Selective Screening Study to Investigate the Frequency of Neuronal Ceroid Lipofuxinosis Type 2 (CLN2)

Brief Summary: This study is a multicenter, non-drug screening study. Enrollment period is 12 months. There are no IMP to be followed or used in the study. Patients who applied to Pediatric Metabolism, Pediatric Neurology and Developmental Pediatrics clinics with the symptoms or findings defined in the protocol as below for 12 months will be included in the study. Children between the ages of 2 and 6, without hypoxic ischemic encephalopathy, head trauma and developmental brain anomalies, who are admitted to the Pediatric Metabolism, Pediatric Neurology and Developmental Pediatrics clinics with non-specific neurological symptoms such as idiopathic seizures of unknown etiology, speech disorders and motor dysfunctions, will constitute the target population of the study.

Recruiting

Start Date:
2023-09-06

Close Date:
2025-03

Interventions:

GENETIC: Blood Sampling

Recruiting

Start Date:
2023-09-06

Close Date:
2025-03

Interventions:

GENETIC: Blood Sampling

ClinicalTrials.gov

A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex

Brief Summary: The goal of this clinical trial is to learn the best way to switch children with Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome (DS) taking 'artisanal' (non pharmaceutical-grade) cannabidiol (CBD) to Epidiolex for treatment of seizures. The main questions it aims to answer are: * How well does a gradual switch from 'artisanal' CBD to Epidiolex work? * Does the same dose of Epidiolex as 'artisanal' CBD work best? * What side-effects or medical problems do participants have when switching from 'artisanal' CBD to Epidiolex? Researchers will examine how successful switching from 'artisanal' CBD to Epidiolex is. Participants will: * Gradually increase their dose of Epidiolex and reduce their dose of 'artisanal' CBD until they are taking just Epidiolex * Visit the clinic five times over 20 weeks for checkups and tests * Keep a diary of their seizures, symptoms and the number of times they use a rescue seizure medication

Not yet recruiting

Start Date:
2026-02-02

Close Date:
2028-12

Interventions:

DRUG: Epidiolex 100 mg/mL Oral Solution

Not yet recruiting

Start Date:
2026-02-02

Close Date:
2028-12

Interventions:

DRUG: Epidiolex 100 mg/mL Oral Solution

ClinicalTrials.gov

Glioblastoma Remote Monitoring and Care - Research Protocol

Brief Summary: The purpose of this research is to learn more about how what the Apple watch measures, in terms of walking data, heart rate, breathing rate, and sleep habits, relates to how participants feel. During the course of the treatment, the symptoms participants experience change, and whether the Apple watch can detect these changes. Ultimately, this knowledge is being used to design proactive tools and signatures that can predict complications or symptom changes before they happen.

Recruiting

Start Date:
2024-04-30

Close Date:
2027-12

Interventions:

DEVICE: Apple Watch

Recruiting

Start Date:
2024-04-30

Close Date:
2027-12

Interventions:

DEVICE: Apple Watch

ClinicalTrials.gov

The Evaluation of the Effectiveness of Febrile Seizure Training Given to Parents

Brief Summary: Objective: The aim of this study was to evaluate the effectiveness of a video-based educational intervention delivered via QR code to parents of hospitalized children aged 6 months to 5 years-an age group in which febrile seizures are most commonly observed.

Active, not recruiting

Start Date:
2024-11-29

Close Date:
2025-06-20

Interventions:

OTHER: The video based education group

Active, not recruiting

Start Date:
2024-11-29

Close Date:
2025-06-20

Interventions:

OTHER: The video based education group

ClinicalTrials.gov

Boosting The Intervention Effect of Negative Memory Through tACS Stimulation

Brief Summary: The objectives of this study include: 1) investigating the impact of negative memory substitution on an individual's other intellectual memories (i.e., neutral memories) and the underlying neurocognitive mechanisms; 2) investigating the memory enhancement effect resulting from retrieval practice associated with memory substitution intervention along with an examination of the neurocognitive mechanisms responsible for this enhancement.

Not yet recruiting

Start Date:
2024-08-15

Close Date:
2024-12-31

Interventions:

DEVICE: Active tACS Device
DEVICE: Sham tACS Device

Not yet recruiting

Start Date:
2024-08-15

Close Date:
2024-12-31

Interventions:

DEVICE: Active tACS Device
DEVICE: Sham tACS Device

ClinicalTrials.gov

Reflexology on Seizure Frequency, Fatigue, Stress and Sleep Quality in Epilepsy Patients

Brief Summary: Epilepsy is among the diseases that cause loss of neurological abilities regardless of any trauma. Reflexology is one of the complementary therapies based on activating the body's self-healing power through special hand techniques applied to the feet. It is known that there are positive changes in seizure frequency, fatigue, stress and sleep quality in epilepsy patients after reflexology. This study will be conducted to determine the effect of reflexology on seizure frequency, fatigue, stress and sleep quality in epilepsy patients.

Recruiting

Start Date:
2023-08-15

Close Date:
2023-12-15

Interventions:

BEHAVIORAL: Reflexology Massage

Recruiting

Start Date:
2023-08-15

Close Date:
2023-12-15

Interventions:

BEHAVIORAL: Reflexology Massage

ClinicalTrials.gov

A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children with SCN1A-positive Dravet Syndrome (Australia Only)

Brief Summary: WAYFINDER is a Phase 1/2 study in Australia to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet syndrome aged 6 to \<84 months. The study follows an open-label, dose-escalation design.

Recruiting

Start Date:
2024-02-28

Close Date:
2030-06

Interventions:

DRUG: ETX101

Recruiting

Start Date:
2024-02-28

Close Date:
2030-06

Interventions:

DRUG: ETX101

ClinicalTrials.gov

Register for Patients With Thyroid Hormone Resistance.

Brief Summary: Thyroid hormones (TH) play a pivotal role in the development and function of the mammalian brain. Patients with impaired thyroid hormone transport into the brain tissue or in the case of defective local thyroid hormone receptor (collectively referred to as thyroid hormone resistance) subsequently experience psychomotor disabilities. The "DEEPTYPE" registry has been established with the objective of intensifying the genotyping and, in particular, the neurological phenotyping of patients exhibiting deficiencies in either the thyroid hormone transporter (MCT8) or the thyroid hormone receptor alpha (THRα). The objective of this registry-based study is to enhance the diagnostic yield for MCT8 and THRα deficiencies by employing the serum fT3/fT4 ratio as a more sophisticated screening parameter. Furthermore, the investigators will study the genomic regulation of both genes and attempt to identify further coding and non-coding mutations that result in TH resistance. The patient registry "DEEPTYPE" will document the retrospective and prospective clinical data of identified children in a comprehensive manner. This will enable the identification of three key groups: (i) patients with non-coding mutations, (ii) patients with milder phenotypes presenting only with a subset of symptoms seen in both "classic" conditions, and (iii) patients who are ready for clinical trials.

Recruiting

Start Date:
2021-07-01

Close Date:
2029-07-31

Interventions:

OTHER: no intervention

Recruiting

Start Date:
2021-07-01

Close Date:
2029-07-31

Interventions:

OTHER: no intervention

ClinicalTrials.gov

Criteria for Advanced Prosthetic Foot Prescription

Brief Summary: The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine the appropriate functional outcome tests and measures to support the prescription of a type of Energy Storing and Returning (ESR) non-articulating, articulating or active plantarflexion prosthetic ankle-foot for a Veteran or Service Member with transtibial limb loss. 2) Correlate patient goals and subjective measures with objective data to determine the appropriate prosthetic ankle-foot category that will facilitate the greatest overall function to the user. 3) Develop criteria for the appropriate prescription of non-articulating ESR, articulating ESR, and active plantar flexion ESR ankle-foot units.

Active, not recruiting

Start Date:
2017-08-01

Close Date:
2025-12-31

Interventions:

DEVICE: ESR Prosthetic Foot First
DEVICE: Articulating ESR Prosthetic Foot First
DEVICE: Powered Prosthetic Foot First

Active, not recruiting

Start Date:
2017-08-01

Close Date:
2025-12-31

Interventions:

DEVICE: ESR Prosthetic Foot First
DEVICE: Articulating ESR Prosthetic Foot First
DEVICE: Powered Prosthetic Foot First

ClinicalTrials.gov

Study of Pathophysiology of Status Epilepticus and Dysimmune Encephalitis

Brief Summary: COLETTE is an interventional study for which blood, cerebrospinal fluid and post-mortem tissues are collected in patients with status epilepticus or epilepsy associated to dysimmune encephalitis as well as in control patients, to better understand the pathophysiology of these severe epileptic disorders.

Recruiting

Start Date:
2020-11-25

Close Date:
2027-06-01

Interventions:

OTHER: Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3)
OTHER: Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3)

Recruiting

Start Date:
2020-11-25

Close Date:
2027-06-01

Interventions:

OTHER: Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3)
OTHER: Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3)

ClinicalTrials.gov

ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.

Brief Summary: To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.

Recruiting

Start Date:
2022-07-12

Close Date:
2027-01-31

Interventions:

DRUG: Cenobamate

Recruiting

Start Date:
2022-07-12

Close Date:
2027-01-31

Interventions:

DRUG: Cenobamate

ClinicalTrials.gov

Benzodiazepine Study for the Treatment of Seizure Clusters in a Third Level Mexican Neurological Center

Brief Summary: The aim of this study is to determine the efficacy in seizure reduction when comparing orodispersable clonazepam versus usual treatment (i.e. medication load, intravenous high- dose benzodiazepines) of seizure clusters in a third level center of care in Mexico city.

Recruiting

Start Date:
2023-05-01

Close Date:
2024-12-31

Interventions:

DRUG: Midazolam oral solution
DRUG: ClonazePAM Oral Product
OTHER: Usual medication/ traditional

Recruiting

Start Date:
2023-05-01

Close Date:
2024-12-31

Interventions:

DRUG: Midazolam oral solution
DRUG: ClonazePAM Oral Product
OTHER: Usual medication/ traditional

ClinicalTrials.gov

Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy

Brief Summary: Cerebral cavernous malformation (CCM)-related epilepsy (CRE) impairs the quality of life in patients with CCM. Patients could not always achieve seizure freedom after surgical resection of the lesion, suggesting an inadequate treatment and evaluation of the epileptogenic zone or network. Iron deposition in cerebral cavernous malformations has been postulated to play an important role in triggering CRE. Quantitative susceptibility mapping (QSM), as an optimal in vivo imaging technique to quantify iron deposition, is employed to analyze the iron quantity in CCM patients with epilepsy and further combined with brain structural and connectome analysis, to describe the difference between CCMs with and without epilepsy. In vivo biomarkers predicting CRE risk in CCM natural history and CRE control outcome after CCM surgical resection will be further identified to improve management strategy.

Recruiting

Start Date:
2019-09-03

Close Date:
2026-12-31

Recruiting

Start Date:
2019-09-03

Close Date:
2026-12-31

ClinicalTrials.gov

Wearable Epileptic Seizure Prediction and Alert Glasses Based on Neuromorphic Computing

Brief Summary: The NEXA study aims to evaluate a new wearable EEG device designed as smart glasses with dry electrodes positioned according to the 10-20 system. The device captures real-time brain signals to detect patterns that may predict seizures, helping people with epilepsy. This study will test the device's safety, performance, and usability before seeking regulatory approval, including FDA clearance. The NEXA device is investigational and not yet approved by the U.S. FDA. The study will involve human participants who will wear the device while data is collected and analyzed. Results will help improve the device and support future certification for medical use.

Active, not recruiting

Start Date:
2025-08-10

Close Date:
2025-12-31

Interventions:

DEVICE: Wearable seizure prediction and alert glasses

Active, not recruiting

Start Date:
2025-08-10

Close Date:
2025-12-31

Interventions:

DEVICE: Wearable seizure prediction and alert glasses

ClinicalTrials.gov

Rapid-Response EEG in Children With Suspected Status Epilepticus

Brief Summary: Seizures are common in children (\~350 per 100,000 patients per year) and require immediate medical attention. If the seizure is prolonged (\> 5 minutes) it is called status epilepticus and delayed treatment leads to higher risk in drug resistance and brain injury. The current standard of care for children admitted to the ICU with established or suspected status epilepticus is to start a conventional continuous EEG study that helps diagnosing seizures by typical electro graphic patterns. It takes on average 4 hours to start and another two hours to obtain a reading by epileptologists. This is far beyond the time window of starting an EEG study (60 minutes) as recommended by the neurocritical care society. In adult ICUs, point of care "Rapid Response EEG" are becoming a new standard of care and our ICU adopted this practice in 2020. It can be easily placed by the ICU staff rather than a specifically trained EEG technician but has a lower resolution due to fewer leads (10 vs. 20). The purpose of this study is to determine wether and by how much time RR-EEG yields faster preliminary EEG reports that the previously available conventional EEG (cEEG) and wether the detection of electro graphic seizures is comparable. This is a retrospective cohort study following patients who are admitted to the PICU and are placed on either cEEG or RR-EEG for status epilepticus.

Recruiting

Start Date:
2021-12-09

Close Date:
2026-12-08

Interventions:

DEVICE: Rapid Response EEG

Recruiting

Start Date:
2021-12-09

Close Date:
2026-12-08

Interventions:

DEVICE: Rapid Response EEG

ClinicalTrials.gov

Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic Kids (PEAK-SEEK)

Brief Summary: The goal of this pragmatic, decentralized, pre-consented, event-driven, randomized controlled trial is to investigate the efficacy of add-on ketamine to second-dose midazolam for prehospital treatment of epileptic children with convulsive status epilepticus.

Recruiting

Start Date:
2025-08-03

Close Date:
2026-08-01

Interventions:

DRUG: Ketamine
DRUG: Midazolam

Recruiting

Start Date:
2025-08-03

Close Date:
2026-08-01

Interventions:

DRUG: Ketamine
DRUG: Midazolam

ClinicalTrials.gov

Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures

Brief Summary: The purpose of this research is to determine the optimal dose, safety and tolerability of zonisamide oral suspension in children ages 1 month to 17 years of age who have partial-onset (focal) seizures. The study consists of four periods: a Screening Period (about 14 days), a Titration Period (8 weeks), a Maintenance Period (4 weeks), and a Follow-Up Period (1 week).

Not yet recruiting

Start Date:
2025-12

Close Date:
2026-09

Interventions:

DRUG: Zonisamide Oral Product

Not yet recruiting

Start Date:
2025-12

Close Date:
2026-09

Interventions:

DRUG: Zonisamide Oral Product

ClinicalTrials.gov

Seizure Prediction Using Wearable EEG

Brief Summary: This study is a non-interventional clinical trial analyzing EEG recordings from people with epilepsy. Participants wear a comfortable EEG headband at home for several weeks. The goal is to study changes in brain activity that occur before seizures (called "pre-ictal patterns") and to test whether a software algorithm can predict seizures in real-time based on these patterns. No treatments or medications are being tested. The study will help evaluate whether seizure prediction is possible using wearable EEG devices and can support the development of future tools that give patients early warnings before seizures occur.

Recruiting

Start Date:
2025-06-19

Close Date:
2026-03

Interventions:

DEVICE: Wearable EEG headband for passive brain signal acquisition

Recruiting

Start Date:
2025-06-19

Close Date:
2026-03

Interventions:

DEVICE: Wearable EEG headband for passive brain signal acquisition

ClinicalTrials.gov

Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY

Brief Summary: This is a prospective, observational study on approximately 70-100 Real World participants affected by LGS, DS, or TSC treated with Epidyolex® as prescribed in the summary of product characteristics. The eligible participants are expected to participate in the study for a duration of 52 weeks of treatment.

Recruiting

Start Date:
2025-02-24

Close Date:
2026-01

Interventions:

DRUG: Epidiolex 100 mg/mL Oral Solution

Recruiting

Start Date:
2025-02-24

Close Date:
2026-01

Interventions:

DRUG: Epidiolex 100 mg/mL Oral Solution

ClinicalTrials.gov

An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures

Brief Summary: An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic Seizures

Recruiting

Start Date:
2025-01-10

Close Date:
2025-07

Interventions:

DRUG: 30mg PRAX-628

Recruiting

Start Date:
2025-01-10

Close Date:
2025-07

Interventions:

DRUG: 30mg PRAX-628

ClinicalTrials.gov

Improving Status Epilepticus Treatment Times

Brief Summary: This is a stepped-wedge cluster randomized effectiveness-implementation hybrid study aimed at determining the effect of dissemination of a QI bundle on the time to treatment of SE among hospitalized, non-critically ill children. The primary study endpoint is to decrease the time from the SE diagnosis to treatment with the first dose of a benzodiazepine (BZD) as measured during hospitalization, which will decrease chances of morbidity and mortality.

Recruiting

Start Date:
2024-02-01

Close Date:
2027-03-31

Interventions:

OTHER: Quality improvement bundle
OTHER: Quality improvement bundle and local PDSA cycles with central support
OTHER: Quality improvement bundle and local PDSA cycles without central support

Recruiting

Start Date:
2024-02-01

Close Date:
2027-03-31

Interventions:

OTHER: Quality improvement bundle
OTHER: Quality improvement bundle and local PDSA cycles with central support
OTHER: Quality improvement bundle and local PDSA cycles without central support

ClinicalTrials.gov

Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)

Brief Summary: A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)

Recruiting

Start Date:
2024-12-11

Close Date:
2025-12-08

Interventions:

DRUG: 20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks
DRUG: Placebo

Recruiting

Start Date:
2024-12-11

Close Date:
2025-12-08

Interventions:

DRUG: 20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks
DRUG: Placebo

ClinicalTrials.gov

Seizure Rescue Medication (RM) As Part of a Comprehensive Epilepsy Self-management Package of Care

Brief Summary: This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings. Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures.

Recruiting

Start Date:
2024-03-05

Close Date:
2026-01-01

Interventions:

BEHAVIORAL: SMART RM
DRUG: Valtoco Nasal Product

Recruiting

Start Date:
2024-03-05

Close Date:
2026-01-01

Interventions:

BEHAVIORAL: SMART RM
DRUG: Valtoco Nasal Product

ClinicalTrials.gov

REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization

Brief Summary: The Study is an observational, retrospective study which aim is to assess cenobamate's healthcare resources utilization (HCRU) in the management of uncontrolled focal onset seizures. The amin objective is to compare the resource utilization before and after the use of cenobamate. Data from medical charts will be used and inserted into the eCRF from which the analyses will be conducted. Data from 200 patients from 10 sites in 5 countries are included.

Recruiting

Start Date:
2024-12-19

Close Date:
2025-12-30

Recruiting

Start Date:
2024-12-19

Close Date:
2025-12-30

ClinicalTrials.gov

SLC13A5 Deficiency Natural History Study - United States Only

Brief Summary: SLC13A5 deficiency (Citrate Transporter Disorder, EIEE 25) is a rare genetic disorder with neurodevelopmental delays and seizure onset in the first few days of life. This natural history study is designed to address the lack of understanding of disease progression. Additionally it will identify clinical and biomarker endpoints for use in future clinical trials.

Enrolling by invitation

Start Date:
2021-12-01

Close Date:
2025-09-30

Enrolling by invitation

Start Date:
2021-12-01

Close Date:
2025-09-30

ClinicalTrials.gov

Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)

Brief Summary: Concurrent electroencephalography (EEG) and new tripolar EEG (tEEG) will be recorded from adult and pediatric patients. In some patients stereo EEG (sEEG) will also be recorded concurrently.

Not yet recruiting

Start Date:
2024-10-01

Close Date:
2026-08-03

Interventions:

DEVICE: Tripolar electroencephalography

Not yet recruiting

Start Date:
2024-10-01

Close Date:
2026-08-03

Interventions:

DEVICE: Tripolar electroencephalography

ClinicalTrials.gov

Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy

Brief Summary: This protocol proposes an initial randomized clinical trial that includes all patients with suicidal ideation (SI) at baseline, and with SI as the primary outcome measure to examine whether Right Unilateral Low-Amplitude Pulse - Seizure Therapy (RUL LAP-ST) treatment has more magnitude and rate of remission of SI as conventional pulse amplitude Right Unilateral Electroconvulsive Therapy (RUL ECT) (based on our prior secondary analysis). Our central hypothesis is that RUL LAP-ST has significantly less cognitive/memory side effects (no memory side effects were noted in our prior studies for 500mA and 600mA) and thus is more favorable in terms of side effects compared to RUL conventional pulse amplitude ECT, while maintaining better anti-suicidal effect.

Recruiting

Start Date:
2024-07-03

Close Date:
2026-11-01

Interventions:

DEVICE: Sigma-Stim

Recruiting

Start Date:
2024-07-03

Close Date:
2026-11-01

Interventions:

DEVICE: Sigma-Stim

ClinicalTrials.gov

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits

Brief Summary: Methylphenidate (MPH) is a stimulant, FDA-approved for the treatment of attention deficit hyperactivity disorder (ADHD). It is unknown, however, if stimulants would be of benefit for memory and thinking problems due to epilepsy. In this study, participants will be assigned randomly (i.e., by flip of a coin), to a group that takes MPH and a group that takes a placebo (sugar pill). Participants will not know the group to which they have been assigned. Tests of attention and memory will be completed before taking the study pills and at Week 8. All participants will then have the option of taking MPH for the next two months, and attention and memory will be tested again at Week 16. The study will determine whether methylphenidate is helpful for the treatment of attention and memory problems in adults with epilepsy, and whether the medication is safe and beneficial when taken over an extended time period.

Recruiting

Start Date:
2023-08-14

Close Date:
2027-09-30

Interventions:

DRUG: Methylphenidate
OTHER: Placebo
DRUG: Methylphenidate

Recruiting

Start Date:
2023-08-14

Close Date:
2027-09-30

Interventions:

DRUG: Methylphenidate
OTHER: Placebo
DRUG: Methylphenidate

ClinicalTrials.gov

Status Epilepticus in the Critically Ill Patients

Brief Summary: Convulsive and Non Convulsive Status Epilepticus (SE) and Pseudo Status Epilepticus prospective registry. Data collection using a standardized form : demographic data and data related to the SE, including circumstances of onset, dates and times of onset and of seizure control, on-scene clinical findings, clinical features of the seizures, pre-hospital and hospital care providers, timing of antiepileptic and supportive treatments, results of etiological investigations, cause of SE, type and dosage of antiepileptic drugs. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Glasgow Outcome Scale score at ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the ICU and/or neurologist charts and/or patients phone interview.

Recruiting

Start Date:
2018-02-28

Close Date:
2028-12-31

Recruiting

Start Date:
2018-02-28

Close Date:
2028-12-31

ClinicalTrials.gov

Pro-Epileptic Effects of IV Ketamine

Brief Summary: The investigators evaluated the safety and potential pro-epileptic effects of intravenous (IV) ketamine during procedural sedation in comparison with IV midazolam and IV propofol. Specifically, the study hypothesizes that IV ketamine, at doses used for procedural sedation, exhibits pro-convulsive properties, lowers the epileptic seizure threshold, and may induce interictal epileptiform discharges and/or seizures. Additionally, the investigators assessed the effects of these sedative agents on electroencephalographic (EEG) activity during procedural sedation.

Active, not recruiting

Start Date:
2024-12-01

Close Date:
2025-08-30

Interventions:

DRUG: Ketamine
DRUG: Midazolam
DRUG: Propofol

Active, not recruiting

Start Date:
2024-12-01

Close Date:
2025-08-30

Interventions:

DRUG: Ketamine
DRUG: Midazolam
DRUG: Propofol

ClinicalTrials.gov

Cenobamate Open-Label Extension Study for YKP3089C025

Brief Summary: 52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)

Enrolling by invitation

Start Date:
2019-08-13

Close Date:
2026-08

Interventions:

DRUG: Cenobamate

Enrolling by invitation

Start Date:
2019-08-13

Close Date:
2026-08

Interventions:

DRUG: Cenobamate

ClinicalTrials.gov

Sleep Spindles and Memory in Rolandic Epilepsy

Brief Summary: The investigators are recruiting children with Rolandic epilepsy and children without epilepsy (aged 4 years old and above) for a non-invasive brain imaging study using Magnetic Resonance Imaging (MRI), Magnetoencephalography/Electroencephalography (MEG/EEG), and experimental tasks. The investigators hope to determine the brain circuits and brain rhythms affected in these children and ultimately identify new treatment options for childhood epilepsy patients.

Recruiting

Start Date:
2021-01-16

Close Date:
2025-12-31

Interventions:

OTHER: Auditory stimulation

Recruiting

Start Date:
2021-01-16

Close Date:
2025-12-31

Interventions:

OTHER: Auditory stimulation

ClinicalTrials.gov

RNS System LGS Feasibility Study

Brief Summary: The purpose of the RNS System Lennox-Gastaut Syndrome (LGS) study is to generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with LGS who are refractory to antiseizure medications.

Recruiting

Start Date:
2022-10-04

Close Date:
2026-12-31

Interventions:

DEVICE: RNS System

Recruiting

Start Date:
2022-10-04

Close Date:
2026-12-31

Interventions:

DEVICE: RNS System

Study Website ClinicalTrials.gov

Improving Outcomes for Patients With Life-Threatening Neurologic Illness

Brief Summary: Background: While the intensive care of patients with life-threatening brain illnesses has advanced tremendously, a large number of therapies are still without proper scientific support. This can be partly explained by the fact that mechanisms of initial brain injury are still not well understood. Why additional neurological injury occurs during a patient's stay in the NeuroCritical Care Unit (NCCU) despite current best, evidence-based clinical practices, is also not well understood. However, over the past decade, better tools have become available to measure and monitor the impact of our clinical care on the rapidly changing physiology and chemistry of the injured brain. Some of these tools are CT, MRI, ultrasound, and catheter-based technology measuring blood flow and metabolism. These tools have enabled earlier detection of injury and complications and newer therapeutic strategies. Purpose: Examine disease pathways common to all brain injuries seen in the University of Maryland's 22-bed NCCU. Life-threatening neurological illnesses cared for in the NCCU include massive stroke, bleeding in and around the brain (subarachnoid hemorrhage, intracerebral hemorrhage, subdural hemorrhage, intraventricular hemorrhage), brain tumors, difficult to control seizures, neurologic infections, nerve and muscle diseases (such as myasthenia gravis or Guillain-Barre Syndrome), and spinal cord disorders among others. Many NCCU patients are comatose or paralyzed and may suffer injuries in other parts of the body as well. This effort will require the creation of a robust clinical database for the capture of data including patient characteristics (age, sex), clinical characteristics, medical treatments, surgical interventions, physiological data (such as vital signs, cerebral blood flow, intracranial pressure, cerebral oximetry, etc), laboratory data, and standard-of-care diagnostic studies such as electroencephalography (EEG), ultrasound, CT, MRI, and angiograms. Similar databases exist at other major centers for neurocritical care and have been instrumental to the identification of characteristics both predictive of and associated with outcomes of patients long after their stay in the NCCU. In addition, the samples collected will be included in the University of Maryland Medicine (UMM) Biorepository which is a shared resource to enable biomedical research by University of Maryland faculty.

Recruiting

Start Date:
2014-09-08

Close Date:
2034-01-01

Recruiting

Start Date:
2014-09-08

Close Date:
2034-01-01

ClinicalTrials.gov

Ketamine for the Treatment of Refractory Status Epilepticus

Brief Summary: This pilot feasibility study aims to examine how the timing of ketamine introduction as a third-line anti-seizure medication infusion relates to seizure cessation in patients with refractory status epilepticus (RSE).

Not yet recruiting

Start Date:
2025-11

Close Date:
2028-07

Interventions:

DRUG: Ketamine
DRUG: Midazolam

Not yet recruiting

Start Date:
2025-11

Close Date:
2028-07

Interventions:

DRUG: Ketamine
DRUG: Midazolam

ClinicalTrials.gov

Evaluation of the Epilepsy-related Quality of Life, Seizure-related Accidents and Validation of the Mjn-SERAS Solution in the Normalised Patient Environment with Real-World Data

Brief Summary: The study will be prospective, multicentre, postmarketing clinical study, with a controlled and randomized design, to perform the analysis of 130 subjects with a clinical diagnosis of epilepsy, patients whose clinical semiology of their epilepsy is considered to be of interest for the validation in the day-to-day life a medical device (mjn-SERAS), which has already been validated and certified in Europe with CE mark Class IIa. This new validation will take place in the participant's normalised environment, in individuals between 12 and 65 years of age, of both sexes with a diagnosis of drug-resistant epilepsy to determine the impact in quality of life of the mjn-SERAS on the early detection of epileptic seizures and the generation of a pre-seizure alert with a time window of a minimum of 1 minute.

Recruiting

Start Date:
2023-05-01

Close Date:
2025-06-30

Interventions:

DEVICE: mjn-SERAS

Recruiting

Start Date:
2023-05-01

Close Date:
2025-06-30

Interventions:

DEVICE: mjn-SERAS

ClinicalTrials.gov

Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment

Brief Summary: The purpose of this study is to evaluate the long-term safety in patients with TSC and refractory seizures who are currently receiving everolimus treatment in the Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued treatment as judged by the investigator at the completion of EXIST-3

Active, not recruiting

Start Date:
2017-06-08

Close Date:
2027-08-13

Interventions:

DRUG: everolimus

Active, not recruiting

Start Date:
2017-06-08

Close Date:
2027-08-13

Interventions:

DRUG: everolimus

ClinicalTrials.gov

Effects of Recorded Music on Clinical and EEG Seizure Activity

Brief Summary: This research is being done to determine if Mozart music and/or age-appropriate music can reduce the frequency of seizures and epileptiform discharges.

Recruiting

Start Date:
2023-04-22

Close Date:
2026-03-01

Interventions:

BEHAVIORAL: Music Stimuli

Recruiting

Start Date:
2023-04-22

Close Date:
2026-03-01

Interventions:

BEHAVIORAL: Music Stimuli

ClinicalTrials.gov

Changes in Attentional Control After a Focal Seizure.

Brief Summary: Epilepsy is frequently associated with cognitive and attentional disorders. Several studies have pointed out that there are modifications of brain activity in resting state during peri-ictal period in EEG and functional MRI. However, to date, no study has assessed the changes in attentional control after a seizure. The investigators hypothesize that a localized discharge is associated with a disorganization of the networks engaged in attentional control. In this regard, the investigators propose a prospective longitudinal study assessing the changes in attentional control after a focal seizure.

Recruiting

Start Date:
2024-03-04

Close Date:
2027-03-09

Interventions:

OTHER: All included subjects

Recruiting

Start Date:
2024-03-04

Close Date:
2027-03-09

Interventions:

OTHER: All included subjects

ClinicalTrials.gov

Magnetic Seizure Therapy for Psychotic Disorders

Brief Summary: This trial aims to evaluate the efficacy and safety of Magnetic Seizure Therapy (MST) as an augmentation of antipsychotic medications for psychosis.

Not yet recruiting

Start Date:
2024-09-01

Close Date:
2025-12-30

Interventions:

DEVICE: Magnetic seizure therapy by Magnetic stimulator
DRUG: Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)

Not yet recruiting

Start Date:
2024-09-01

Close Date:
2025-12-30

Interventions:

DEVICE: Magnetic seizure therapy by Magnetic stimulator
DRUG: Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)

ClinicalTrials.gov

Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Brief Summary: Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.

Recruiting

Start Date:
2022-03-30

Close Date:
2025-01

Interventions:

DEVICE: Default CI fitting
DEVICE: Anatomy-based CI fitting

Recruiting

Start Date:
2022-03-30

Close Date:
2025-01

Interventions:

DEVICE: Default CI fitting
DEVICE: Anatomy-based CI fitting

ClinicalTrials.gov

Hybrid Micro-macro Electrodes in Patients with Epilepsy

Brief Summary: The aim of the MicroEPI study is to know whether it is possible to use safely a medical device (a micro-electrode) that allows recording the activity of neurons in the human brain. Patients who suffer from drug-resistant epilepsy and who are candidates to epilepsy surgery to alleviate their condition sometimes require the implantation of intracranial EEG electrodes for a few weeks, in order to determine as best as possible which region of the brain to operate on. In the MicroEPI study, some of these electrodes will also comprise micro-electrodes, allowing us to record the activity of the patients' neurons during their epileptic seizures.

Recruiting

Start Date:
2023-03-30

Close Date:
2027-09

Interventions:

DEVICE: micro-macro electrode implantation

Recruiting

Start Date:
2023-03-30

Close Date:
2027-09

Interventions:

DEVICE: micro-macro electrode implantation

ClinicalTrials.gov

An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome

Brief Summary: This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).

Recruiting

Start Date:
2025-04-09

Close Date:
2029-11-01

Interventions:

DRUG: Clemizole HCl
DRUG: Placebo

Recruiting

Start Date:
2025-04-09

Close Date:
2029-11-01

Interventions:

DRUG: Clemizole HCl
DRUG: Placebo

ClinicalTrials.gov

Pharmacological Modulation of Brain Oscillations in Memory Processing

Brief Summary: The goal of this study is to learn about the effects of scopolamine (an anticholinergic drug) on areas of the brain involved in memory, and changes it may have on brain activity. The investigators will do this by testing epileptic patients who are already undergoing intracranial surgery for seizure monitoring, and measuring the activity from the brain areas being assessed. The main questions it aims to answer are 1) whether scopolamine changes memory activity solely at encoding (the time when the person perceives and determines to remember an item or event) as has previously been found, or if it also can selectively impact retrieval (when the item or event which has been processed is recalled or remembered), and 2) what the nature of the brain activity changes is. Participants will complete two treatment arms. One of these will be with the drug, and the other will be with a saline solution, so that the participants are unaware which session the actual drug has been received. Patients will complete a verbal and/or spatial task each of the two days. An anesthesiologist will administer either the drug or the saline at a critical point which addresses both of the research questions. Researchers will compare the brain activity between the two treatment arms to determine what brain activity changes, and at what time point during memory formation.

Recruiting

Start Date:
2019-08-01

Close Date:
2027-05-31

Interventions:

DRUG: Scopolamine (0.4mg)
DRUG: Placebo

Recruiting

Start Date:
2019-08-01

Close Date:
2027-05-31

Interventions:

DRUG: Scopolamine (0.4mg)
DRUG: Placebo

ClinicalTrials.gov

Outcomes Mandate National Integration With Cannabis as Medicine

Brief Summary: This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

Recruiting

Start Date:
2018-12-01

Close Date:
2025-12-31

Interventions:

DRUG: Cannabis, Medical
DEVICE: RYAH-Medtech Inhaler

Recruiting

Start Date:
2018-12-01

Close Date:
2025-12-31

Interventions:

DRUG: Cannabis, Medical
DEVICE: RYAH-Medtech Inhaler

ClinicalTrials.gov

Cenobamate in Adults With Focal-Onset Seizures

Brief Summary: The BLESS Study contributes to filling this information gap by collecting data from the Italian clinical practice and the Compassionate Use Program, to better characterize the clinical profile of cenobamate describing its effectiveness, safety and tolerability in adult patients diagnosed with uncontrolled focal epilepsy despite the use of at least two antiepileptic medicinal products.

Active, not recruiting

Start Date:
2023-01-24

Close Date:
2025-12

Active, not recruiting

Start Date:
2023-01-24

Close Date:
2025-12

ClinicalTrials.gov

STARS - Stand Together Against pRolonged Seizures

A clinical study for people with epilepsy who experience prolonged seizures.

Brief Summary: The STARS Study evaluates if an inhaler containing an investigational drug is able to quickly stop prolonged seizures (i.e. lasting more than 3 minutes) once they have begun. During this initial study the inhaler will be used to treat one seizure during the 12-week period, and participants will also be able to use rescue medications should their seizure persist after using the inhaler.

Contact Information: For more study information, please contact an experienced Patient Navigator at +1 470-523-2502.

Recruiting

Start Date:
2021-12-07

Close Date:
2026-04-06

Interventions:

DRUG: Staccato alprazolam
OTHER: Placebo

Recruiting

Start Date:
2021-12-07

Close Date:
2026-04-06

Interventions:

DRUG: Staccato alprazolam
OTHER: Placebo

Study Website ClinicalTrials.gov

Astroscape: A Study of Radiprodil on Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II

Brief Summary: Study RAD-GRIN-201 is a phase 1B/2A trial to assess safety, tolerability, pharmacokinetics (PK), and potential efficacy of radiprodil in participants with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) type II. The study is open-label, so all participants will be treated with radiprodil. Subjects' participation in the study is expected to last up to six months in Part A and one year in Part B/long-term treatment period. The treatment period in Part B may be extended based on a favorable benefit/risk profile.

Recruiting

Start Date:
2024-07-10

Close Date:
2026-07

Interventions:

DRUG: Radiprodil

Recruiting

Start Date:
2024-07-10

Close Date:
2026-07

Interventions:

DRUG: Radiprodil

ClinicalTrials.gov

Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans

Brief Summary: Since 2000, at least 250,000 U.S. Service members have experienced a blast-related mild traumatic brain injury. A retrospective analysis of over 100,000 post-9/11 Veterans shows that blast injury more than doubles the risk of a diagnosed auditory problem. Many blast-exposed Veterans experience "functional hearing difficulties" (FHDs): problems in challenging listening environments despite clinically normal hearing as measured by the pure-tone audiogram. VA audiologists have begun using low-gain hearing aids to treat FHDs, but there are no concrete guidelines for this application given standard procedures rely on the pure-tone audiogram. This study proposes a data-driven approach called speech-based audiometry (SBA), which optimizes hearing aid gains from a patient's responses to speech stimuli in aided conditions. This trial will assess the behavioral (speech recognition in noise, subjective listening difficulty) and neurophysiological (functional neuroimaging during a speech recognition task) benefits of low-gain hearing aids programmed conventionally or with SBA among blast-exposed Veterans with FHDs.

Recruiting

Start Date:
2024-04-01

Close Date:
2028-03-31

Interventions:

DEVICE: Phonak Lumina P90

Recruiting

Start Date:
2024-04-01

Close Date:
2028-03-31

Interventions:

DEVICE: Phonak Lumina P90

ClinicalTrials.gov

Echo and ECG Findings in Neuropediatrics

Brief Summary: Evaluate the echo-electrocardiographic findings in patients with neurological affection to identify potential cardiac involvement, and explore correlation between cardiac and neurological abnormalities.Objectives are To assess echocardiographic findings in patients with neurological affection , to analyze ECG patterns in the same patient group and to explore clinical significance of detected cardiac findings in the management of neurological patients.

Not yet recruiting

Start Date:
2025-10-01

Close Date:
2026-10

Not yet recruiting

Start Date:
2025-10-01

Close Date:
2026-10

ClinicalTrials.gov

Oscillatory Activity in Basal Ganglia Circuits During Normal and Pathological Movement

Brief Summary: The expression of hypokinetic and hyperkinetic motor symptoms is accompanied by pathological synchronous oscillations of neuronal activity in this cortico-subcortical network with a wide frequency range. The purpose of this research is to study cortico-subcortical oscillations and their synchronization in two pathologies emblematic of hypokinetic (Parkinson's disease) and hyperkinetic (epilepsies) phenomena using a simple motor task and comparing different situations.

Recruiting

Start Date:
2024-02-05

Close Date:
2027-02-05

Interventions:

PROCEDURE: High Resolution Electroencephalogram (EEG-HR)
PROCEDURE: Stereo-electro-encephalography (SEEG)

Recruiting

Start Date:
2024-02-05

Close Date:
2027-02-05

Interventions:

PROCEDURE: High Resolution Electroencephalogram (EEG-HR)
PROCEDURE: Stereo-electro-encephalography (SEEG)

ClinicalTrials.gov

Tumor Related Epilepsy

Brief Summary: Background: Some people with brain tumors have seizures related to the tumor. This is called tumor-related epilepsy. Usually brain tumors are treated by removing as much of the brain tumor as possible without causing problems. Researchers think this may improve the outcome for people with brain tumors. It may completely relieve or greatly reduce the number of seizures they have. Objectives: To evaluate people with brain tumors that are associated with seizures and to offer surgical treatment. Also, to study how surgery affects seizures. Eligibility: People age 8 and older who have a brain tumor with associated seizures. They must be willing to have brain surgery to treat their epilepsy. Design: Participants will be screened with a review of their medical records. Participants will have a medical history and physical exam. Participants will be admitted to the hospital at NIH. They will have Medical history Physical exam Neurological exam Tests of memory, attention, and thinking Questions about their symptoms and quality of life Blood drawn They may also have: MRI or CT scan. They will lie on a table that slides in and out of a machine that takes pictures. For part of the MRI, they will get a dye through an intravenous (IV) catheter. Video electroencephalography monitoring. Electrodes will be placed on the scalp. The participant s brain waves will be recorded while doing normal activities. Participants will be videotaped. Participants will keep a seizure diary before and after surgery. Participants will have surgery to remove their brain tumor and the brain area where their seizures start. They will stay in the hospital up to a week after surgery. Participants have for follow-up visits at NIH.

Recruiting

Start Date:
2016-01-26

Close Date:
2032-07-01

Recruiting

Start Date:
2016-01-26

Close Date:
2032-07-01

ClinicalTrials.gov

Prospective Regional Epilepsy Database

Brief Summary: PREDICT is an observational study following adults with an unprovoked seizure or epilepsy in the health care region of western Sweden. The objective is to identify biomarkers and/or genetic predisposition of relevance for diagnosis and/or treatment of epilepsy and study the long-term prognosis and consequences of epilepsy.

Recruiting

Start Date:
2020-11-27

Close Date:
2031-12-31

Interventions:

OTHER: Seizure status
DIAGNOSTIC_TEST: Tests
OTHER: Epilepsy
OTHER: Demographics and psychosocial
OTHER: Health care

Recruiting

Start Date:
2020-11-27

Close Date:
2031-12-31

Interventions:

OTHER: Seizure status
DIAGNOSTIC_TEST: Tests
OTHER: Epilepsy
OTHER: Demographics and psychosocial
OTHER: Health care

ClinicalTrials.gov

Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

Brief Summary: To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures

Recruiting

Start Date:
2022-11-04

Close Date:
2027-01-31

Interventions:

DRUG: Cenobamate

Recruiting

Start Date:
2022-11-04

Close Date:
2027-01-31

Interventions:

DRUG: Cenobamate

ClinicalTrials.gov

BHV-7000 Responsive Neurostimulation System (RNS) Study

Brief Summary: This is an open label study to assess the biological effect of BHV-7000 on abnormal activity recorded by the RNS System in patients with focal epilepsy implanted with the RNS System. BHV-7000 is a potassium channel activator being evaluated for use in epilepsy. Participants are offered the drug for 4 weeks. Activity during that treatment period is compared to a 90-day retrospective baseline period in which other medications and device settings were stable, and also to a 4-week withdrawal period after treatment is discontinued. The study is open to patients with RNS regardless of whether they report clinical seizures, as long as the device recordings continue to show epileptiform activity.

Recruiting

Start Date:
2025-10-07

Close Date:
2026-09

Interventions:

DRUG: BHV-700

Recruiting

Start Date:
2025-10-07

Close Date:
2026-09

Interventions:

DRUG: BHV-700

ClinicalTrials.gov

Phenobarbital Versus Levetiracetam Neonatal Convulsion

Brief Summary: If the seizure is clinically evident and prolonged, the most common first-line agent utilized is phenobarbital.(Glass et al;2016) ,Its mechanism of action is the synaptic inhibition through an action on GABA receptors, It can not only control seizures but also reduce the metabolism of the brain .(Geneva;2011) ,Phenobarbital can control 43-80% of electrical seizures (abnormal electroencephalograms) in newborns.(Sharpe et al;2020) Levetiracetam can also be used for treatment of neonatal seizures, which is safer than phenobarbital, it's mechanism of action is modulation of synaptic neurotransmitter release through binding to the synaptic vesicle protein SV2A in the brain, with less side effects on cognitive development in the levetiracetam treated subjects.(maigre et al;2013)

Not yet recruiting

Start Date:
2023-12-30

Close Date:
2025-05-30

Not yet recruiting

Start Date:
2023-12-30

Close Date:
2025-05-30

ClinicalTrials.gov

Observational Study on Dynamic Changes of Blood Pressure During Post-epileptic Seizure Stage (OCBPS)

Brief Summary: This article details a multicenter study on changes of blood pressure and heart rate during post-epileptic seizure stage.

Recruiting

Start Date:
2025-01-26

Close Date:
2025-10-30

Recruiting

Start Date:
2025-01-26

Close Date:
2025-10-30

ClinicalTrials.gov

Clinical and Electrographic Changes in Responsive Neurostimulation System (RNS) Patients with Acupuncture Treatment

Brief Summary: The purpose of this study is to determine effects of Acupuncture on a Patient's mood and cognition,evaluate changes in clinically-reported seizure frequency and severity and analyze effects of Acupuncture on electrographic epileptiform activity stored by the RNS System

Recruiting

Start Date:
2021-04-01

Close Date:
2025-12-01

Interventions:

DEVICE: Acupuncture intervention

Recruiting

Start Date:
2021-04-01

Close Date:
2025-12-01

Interventions:

DEVICE: Acupuncture intervention

ClinicalTrials.gov

Connectivity and Neural Signatures of Consciousness in Unresponsive States

Brief Summary: The CONSCIUS study is a prospective, interventional study including patients with acute brain injury and impaired consciousness implanted with intracranial electrodes. The aim of the study is to investigate seizures and thalamocortical neural dynamics underlying behavioral unresponsiveness.

Recruiting

Start Date:
2024-01-01

Close Date:
2027-12-31

Interventions:

DEVICE: Intracranial electrodes

Recruiting

Start Date:
2024-01-01

Close Date:
2027-12-31

Interventions:

DEVICE: Intracranial electrodes

ClinicalTrials.gov

A Study of Objective Fitting for Focused Multipolar Stimulation

Brief Summary: The purpose of this exploratory study is to trial various objective and behavioural fitting methods for potential use with Focused Multipolar Stimulation programming.

Active, not recruiting

Start Date:
2024-02-08

Close Date:
2026-02

Interventions:

DEVICE: The Phoenix Research System

Active, not recruiting

Start Date:
2024-02-08

Close Date:
2026-02

Interventions:

DEVICE: The Phoenix Research System

ClinicalTrials.gov

Acoustic Stimulation for Seizure Suppression

Brief Summary: The objective of this study is to test the feasibility and physiological effect of low-frequency (1 Hz) acoustic stimulation delivered during nocturnal NREM sleep in epilepsy patients. The long-term goal is to develop this protocol for daily, long-term use in a home setting, for nocturnal seizure and IED suppression

Enrolling by invitation

Start Date:
2017-08-17

Close Date:
2028-11-21

Interventions:

OTHER: Acoustic 1Hz Stimulation
OTHER: Sham Background Noise

Enrolling by invitation

Start Date:
2017-08-17

Close Date:
2028-11-21

Interventions:

OTHER: Acoustic 1Hz Stimulation
OTHER: Sham Background Noise

ClinicalTrials.gov

Assessment of Pre Hospital Rescue Intervention for Seizure in Pediatric Patients

Brief Summary: 1. Evaluation of pre hospital rescue intervention of seizure management. 2. To investigate the type of rescue medication, Efficacy, route of administration, Side effects of this drug, frequency and Indication of its use.

Not yet recruiting

Start Date:
2025-01

Close Date:
2025-11

Not yet recruiting

Start Date:
2025-01

Close Date:
2025-11

ClinicalTrials.gov

A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex

Brief Summary: The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.

Active, not recruiting

Start Date:
2023-06-29

Close Date:
2026-03-26

Interventions:

DRUG: Cannabidiol Oral Solution [Epidiolex]

Active, not recruiting

Start Date:
2023-06-29

Close Date:
2026-03-26

Interventions:

DRUG: Cannabidiol Oral Solution [Epidiolex]

ClinicalTrials.gov

Cardiac Injury With Convulsive Status Epilepticus

Brief Summary: 1. Determine the impact of cardiac injury on clinical profile, cardiac evaluation and outcome in patients hospitalized with convulsive status epilepticus (CSE). 2. Analyze the frequency of cardiac rhythm and conduction abnormalities related to seizures and determine risk factors and associated clinical characteristics. 3. Analyse ECG abnormalities and changes in HR in epileptic seizures since such disturbances might be a factor in SUDEP 4. Assessment of levels of cardiac enzymes in patients with status epilepticus

Not yet recruiting

Start Date:
2024-01-01

Close Date:
2025-03-01

Not yet recruiting

Start Date:
2024-01-01

Close Date:
2025-03-01

ClinicalTrials.gov

The Role of Imaging in the Diagnosis, Management and Prognosis of Possible Non-convulsive Status Epilepticus

Brief Summary: The investigators propose a prospective study of 20 control subjects and 180 consecutive patients with possible non-convulsive status epilepticus (NCSE). The investigators will obtain three functional images of the brain: 1. Fluorodeoxyglucose positron emission tomography (FDG-PET) 2. Perfusion (and structural) magnetic resonance (MR) images 3. Computed tomography (CT) perfusion. Brain hypermetabolism/hyperperfusion is a strong argument to confirm a diagnosis of non-convulsive status epilepticus. The aim is to determine which of the three functional imaging techniques is the most sensitive and easy to obtain in the detection of hypermetabolism/hyperperfusion. The investigators will determine which EEG patterns are associated with hypermetabolism/perfusion. The investigators will further study and describe the management with antiseizure medication and outcome of the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilpticus WITHOUT hypermetabolism/hyperperfusion. The investigators will make recommendations for an imaging protocol in possible NCSE for widespread use. The aim is to offer guidelines to incorporate imaging in the diagnosis, management and prognosis of NCSE in patients with the ictal-interictal continuum.

Recruiting

Start Date:
2023-10-01

Close Date:
2027-09-30

Interventions:

DIAGNOSTIC_TEST: MRI scan including arterial spin labelling of the brain
DIAGNOSTIC_TEST: CT perfusion scan of the brain
DIAGNOSTIC_TEST: FDG-PET scan of the brain

Recruiting

Start Date:
2023-10-01

Close Date:
2027-09-30

Interventions:

DIAGNOSTIC_TEST: MRI scan including arterial spin labelling of the brain
DIAGNOSTIC_TEST: CT perfusion scan of the brain
DIAGNOSTIC_TEST: FDG-PET scan of the brain

ClinicalTrials.gov

SLC13A5 Deficiency Natural History Study - Remote Only

Brief Summary: SLC13A5 deficiency (Citrate Transporter Disorder, EIEE 25) is a rare genetic disorder with neurodevelopmental delays and seizure onset in the first few days of life. This natural history study is designed to address the lack of understanding of disease progression and genotype-phenotype correlation. Additionally it will help in identifying clinical endpoints for use in future clinical trials.

Enrolling by invitation

Start Date:
2021-03-01

Close Date:
2025-09-01

Enrolling by invitation

Start Date:
2021-03-01

Close Date:
2025-09-01

ClinicalTrials.gov

Levetiracetam Prophylaxis in Brain Tumor Resection Pilot

Brief Summary: This study aims to evaluate feasibility of a double-blind randomized controlled trial for levetiracetam prophylaxis for prevention of seizure in the perioperative phase of brain tumor resection.

Not yet recruiting

Start Date:
2025-03

Close Date:
2026-03

Interventions:

DRUG: Levetiracetam
OTHER: Placebo

Not yet recruiting

Start Date:
2025-03

Close Date:
2026-03

Interventions:

DRUG: Levetiracetam
OTHER: Placebo

ClinicalTrials.gov

A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures

Brief Summary: The purpose of this study is to determine the safety of Fycompa for injection after administration in participants with epilepsy (partial-onset seizures \[including secondarily generalized seizures\]) (age 4 years or older) or primary generalized tonic-clonic seizures (age 12 years or older).

Recruiting

Start Date:
2024-11-18

Close Date:
2028-06-15

Interventions:

OTHER: No Intervention

Recruiting

Start Date:
2024-11-18

Close Date:
2028-06-15

Interventions:

OTHER: No Intervention

ClinicalTrials.gov

Transcranial Electric Stimulation Therapy (TEST) for Treatment Resistant Depression (TRD)

Brief Summary: Background: People with TRD are often helped by electroconvulsive therapy (ECT). But ECT can affect memory and thinking. Researchers want to study a treatment called TEST that uses less electricity. Objective: To study the safety and feasibility of TEST and assess its antidepressant effects. Eligibility: Adults aged 25-64 with major depression that has not been relieved by current treatments. Design: Participants will be admitted to the NIH Clinical Center for 5 18 weeks over 2 3 treatment phases. Their medications may be adjusted. Participants will be interviewed about their depression, side effects, and other treatments they are receiving. They will complete questionnaires. They will give blood and urine samples. Their brain waves and heart rhythm will be recorded. They will take tests of memory, attention, mental functioning, and thinking. Participants will have magnetic resonance imaging (MRI) scans of the head and brain. They will lie on a table that slides in and out of the scanner. Pictures of brain chemicals will also be taken. They may complete tasks during the MRI. Participants will receive TEST and/or sham treatments. They may receive optional ECT. An intravenous catheter will be placed in an arm vein to receive general anesthesia. Two electrodes will be placed on the front of their head. An electric current will be passed from the ECT machine through the electrodes. For sham treatments, they will not receive the electric current. Their breathing, heart rate, brain function, blood pressure, and body movements will be measured. Participants will have 7 follow-up visits over 6 months. Visits can be done via telehealth. Participation will last for up to 42 weeks.

Recruiting

Start Date:
2022-11-08

Close Date:
2027-10-31

Interventions:

DEVICE: MagPro TMS Stimulator and coil
DEVICE: Thymatron(R) System IV
DEVICE: Magnetic Resonance Imaging Scanner
OTHER: ECT device without stimulation

Recruiting

Start Date:
2022-11-08

Close Date:
2027-10-31

Interventions:

DEVICE: MagPro TMS Stimulator and coil
DEVICE: Thymatron(R) System IV
DEVICE: Magnetic Resonance Imaging Scanner
OTHER: ECT device without stimulation

ClinicalTrials.gov

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

Brief Summary: A growing body of evidence suggests patients with late-onset seizures are at an increased risk of stroke, but the potential for reducing cardiovascular morbidity through risk factor screening and management is unknown. The investigators aim to determine whether individuals with new-onset unprovoked seizures after middle age should undergo vascular risk assessment. In a cluster project the investigators assess the effect of vascular risk factor screening in an observational study as well as a cohort study. The project has two interlinked components: a prospective single group study, in which risk factor assessment is performed and subsequent management is followed for one year; and a register-based cohort study examining the long-term effects of the intervention on a system level.

Not yet recruiting

Start Date:
2025-09-01

Close Date:
2035-06

Interventions:

OTHER: Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests)

Not yet recruiting

Start Date:
2025-09-01

Close Date:
2035-06

Interventions:

OTHER: Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests)

ClinicalTrials.gov

The Feasibility and Acceptability of an Online Yoga Program for People With Functional Neurological Disorders

Brief Summary: This is a feasibility study to see if it is acceptable and helpful for people living with a functional neurological disorder to receive online group yoga sessions to improve their wellbeing

Not yet recruiting

Start Date:
2025-08

Close Date:
2026-06

Interventions:

OTHER: A12 week, twice weekly, small group, online yoga program

Not yet recruiting

Start Date:
2025-08

Close Date:
2026-06

Interventions:

OTHER: A12 week, twice weekly, small group, online yoga program

ClinicalTrials.gov

Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)

Brief Summary: This open-label, randomized multicenter trial aims at clarifying the standard of care of patients with non-convulsive status epilepticus not responding to treatment with benzodiazepines and at least one high-dose intra venous anti-seizure medication.

Recruiting

Start Date:
2022-02-07

Close Date:
2028-12-31

Interventions:

DRUG: Rapid sedation

Recruiting

Start Date:
2022-02-07

Close Date:
2028-12-31

Interventions:

DRUG: Rapid sedation

ClinicalTrials.gov

Electrochemical and Electrophysiological Study

Brief Summary: This study will utilize computerized algorithms in combination with real-time intracranial neurophysiological and neurochemical recordings and microstimulation to measure cognitive and affective behavior in humans. Questionnaires or simple behavioral tasks (game-like tasks on a computer or an iPad) may also be given to additionally characterize subjects on related cognitive or affective components. Importantly, for the purposes of understanding the function of the human brain, neural activity can be recorded and probed (i.e. microstimulation) while subjects are performing the same computerized cognitive and affective tasks. These surgeries allow for the in vivo examination of human neurophysiology and are a rare opportunity for such research. The questionnaires and assessments proposed will provide insights into disorders (and anxiety, depression) and psychological status that we hope to understand in relation to the neurochemistry measures. They will also provide baseline information that may be used to characterize and group the population to further refine our understanding of the neural responses. In addition to computerized testing, we plan to characterize subjects' behavior on related cognitive or affective components. Some neuropsychological questionnaires, many of which are administered for clinical reasons, may also be given to patients and healthy control subjects. All patients undergoing epilepsy surgery or deep brain stimulation undergo a standard clinical neuropsychological battery to assess aspects of cognitive function. This is a regular aspect of their clinical assessment carried out prior to consideration for study inclusion. All participants are selected uniformly because they are undergoing surgery for intracranial electrode implantation. No particular ethnic group or population is targeted by or excluded from the study. Those to be considered for inclusion in the proposed study performing more than 2 standard deviations below the mean on any aspect of cognitive functioning as determined by standard preoperative neuropsychological testing will be excluded from the study.

Enrolling by invitation

Start Date:
2022-09-07

Close Date:
2027-02

Interventions:

OTHER: Behavioral testing under intracranial monitoring

Enrolling by invitation

Start Date:
2022-09-07

Close Date:
2027-02

Interventions:

OTHER: Behavioral testing under intracranial monitoring

ClinicalTrials.gov

FITting Non-invasive Tests in Lynch Syndrome Surveillance

Brief Summary: The purpose of this clinical study is to evaluate the accuracy of the fecal immunochemical test (FIT) in comparison to colonoscopy in patients with Lynch Syndrome (LS) who are undergoing colonoscopy surveillance.

Recruiting

Start Date:
2025-07-10

Close Date:
2029-07-01

Interventions:

OTHER: Fecal immunochemical test

Recruiting

Start Date:
2025-07-10

Close Date:
2029-07-01

Interventions:

OTHER: Fecal immunochemical test

ClinicalTrials.gov

Anatomy-based Fitting in Cochear Implant Users

Brief Summary: In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes.

Recruiting

Start Date:
2022-03-11

Close Date:
2026-12-31

Interventions:

PROCEDURE: Anatomy-based fitting (ABF)
PROCEDURE: Standard Fitting
PROCEDURE: Standard fitting+ ABF

Recruiting

Start Date:
2022-03-11

Close Date:
2026-12-31

Interventions:

PROCEDURE: Anatomy-based fitting (ABF)
PROCEDURE: Standard Fitting
PROCEDURE: Standard fitting+ ABF

ClinicalTrials.gov

The STatus Epilepticus Prognosis Study

Brief Summary: The goal of this study is to improve the prognosis of patients who present with Status Epilepticus (SE). In the first part of this study, the investigators aim to find better markers of good and poor outcomes of SE patients while in the ICU. The objective is to measure the levels of brain protein micro-particles that are detectable in blood samples. The investigators seek to determine whether elevated levels of micro-particles in the bloodstream in SE patients can be used to predict the eventual outcome of survivors. The goal of the second part of the study is to evaluate long-term cognitive outcomes in survivors of SE To date, there is no reliable information to inform what cognitive recovery is like for survivors of SE after ICU discharge. The objective is to use the Creyos cognitive testing platform to assess different domains of cognitive function for up to 1 year after SE onset. Patients who have pre-existing epilepsy but have not had status epilepticus will serve as patient controls for the cognitive testing portion of this study. The third part of this study will evaluate brain changes in survivors of refractory SE. To date, there are no known studies that document to what extent the anatomy of the brain changes following SE. The objective is to characterize these changes by conducting two brain research scans 6 months apart. Patients will be invited to Robart\'s Research Institute for a scan 1-3 months and 6-8 months (6 months apart) after refractory SE to measure structural and functional changes in the brain throughout the recovery process.

Recruiting

Start Date:
2022-11-27

Close Date:
2026-12-31

Recruiting

Start Date:
2022-11-27

Close Date:
2026-12-31

ClinicalTrials.gov

Magnetic Seizure Therapy for Schizophrenia - Trial

Brief Summary: This trial aims to assess the clinical effects and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Treatment Resistant Schizophrenia (RS).

Not yet recruiting

Start Date:
2025-03

Close Date:
2028-11

Interventions:

DEVICE: Magnetic Seizure Therapy (MST)
DEVICE: Electroconvulsive Therapy (ECT)

Not yet recruiting

Start Date:
2025-03

Close Date:
2028-11

Interventions:

DEVICE: Magnetic Seizure Therapy (MST)
DEVICE: Electroconvulsive Therapy (ECT)

ClinicalTrials.gov

A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder

Brief Summary: This is a multicenter, double-blind, parallel-group, placebo controlled, 2-part study to evaluate the efficacy and safety of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with cyclin-dependent kinase like-5 (CDKL5) deficiency disorder (CDD).

Active, not recruiting

Start Date:
2022-03-08

Close Date:
2027-11-08

Interventions:

DRUG: ZX008 (Fenfluramine Hydrochloride)
DRUG: Matching ZX008 Placebo

Active, not recruiting

Start Date:
2022-03-08

Close Date:
2027-11-08

Interventions:

DRUG: ZX008 (Fenfluramine Hydrochloride)
DRUG: Matching ZX008 Placebo

ClinicalTrials.gov

A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

Brief Summary: The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

Recruiting

Start Date:
2023-05-09

Close Date:
2026-12

Interventions:

DRUG: XEN1101
DRUG: Placebo

Recruiting

Start Date:
2023-05-09

Close Date:
2026-12

Interventions:

DRUG: XEN1101
DRUG: Placebo

ClinicalTrials.gov

A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures

Brief Summary: The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

Active, not recruiting

Start Date:
2022-11-18

Close Date:
2026-02

Interventions:

DRUG: XEN1101
DRUG: Placebo

Active, not recruiting

Start Date:
2022-11-18

Close Date:
2026-02

Interventions:

DRUG: XEN1101
DRUG: Placebo

ClinicalTrials.gov

Effect of the New Definition of Epilepsies of the ILAE of 2014 on the Diagnosis After the First Seizure

Brief Summary: The present study is a prospective study on the development of seizure frequency, medication adherence, quality of life and cognitive performance after a first epileptic seizure using the new diagnostic criteria for epilepsy of the International League Against Epilepsy of 2014 at the time of diagnosis.

Recruiting

Start Date:
2018-03-01

Close Date:
2038-08-01

Recruiting

Start Date:
2018-03-01

Close Date:
2038-08-01

ClinicalTrials.gov

Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables

Brief Summary: The purpose of this study is to evaluate the safety and feasibility of using seizure forecasts based on subscalp EEG.

Recruiting

Start Date:
2025-10

Close Date:
2029-12

Interventions:

DEVICE: UNEEG SubQ device

Recruiting

Start Date:
2025-10

Close Date:
2029-12

Interventions:

DEVICE: UNEEG SubQ device

ClinicalTrials.gov

Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies

Brief Summary: Epileptic spasms (ES) are a predominantly infantile seizure type observed frequently in certain genetic disorders. Ketogenic diet (high ratio of fat to carbohydrate/protein) is an established non-medication treatment for difficult to control seizures, including ES. Because ES are associated with worse developmental and cognitive outcomes if not detected or treated quickly and effectively, this trial aims to test the ketogenic diet to prevent ES in this high-risk population. This trial is a single-center pilot study of 10 infants with genetic seizure disorders to establish if the protocol of early ketogenic diet administration and ES evaluation is safe and feasible.

Recruiting

Start Date:
2025-08-11

Close Date:
2028-05

Interventions:

DRUG: Ketogenic diet

Recruiting

Start Date:
2025-08-11

Close Date:
2028-05

Interventions:

DRUG: Ketogenic diet

ClinicalTrials.gov

Epidemiology Study on Neonatal Seizure

Brief Summary: A Multicentre, observational and cohort study to get the incidence of new-onset or newly-diagnosed seizure in neonatal population. EEG will used to record the change of brain electric activity and diagnose. Other data also will be collected since first seizure until confirmed diagnosis.

Recruiting

Start Date:
2015-09-01

Close Date:
2025-12-30

Recruiting

Start Date:
2015-09-01

Close Date:
2025-12-30

ClinicalTrials.gov

Transcranial Sonographic Evaluation of Preterm Neonates Presenting With Seizures and Its Association With IA

Brief Summary: This study aimed to evaluate preterm neonates presenting with seizures using transcranial sonography (cranial ultrasound) to detect intracranial abnormalities.

Active, not recruiting

Start Date:
2025-03-17

Close Date:
2026-02-28

Interventions:

DIAGNOSTIC_TEST: Transcranial Sonographic Examination (Cranial Ultrasound)

Active, not recruiting

Start Date:
2025-03-17

Close Date:
2026-02-28

Interventions:

DIAGNOSTIC_TEST: Transcranial Sonographic Examination (Cranial Ultrasound)

ClinicalTrials.gov

Targeting the Gut to Improve Seizure Control in CDKL5 Deficiency Disorder (CDD)

Brief Summary: Standard anti-seizure medications have limited efficacy in seizure control in cyclin-dependent kinase-like 5 deficiency disorder (CDD). The study will investigate whether targeting the gut-microbiota-brain axis in CDD patients can alleviate seizures and ameliorate other comorbidities.

Recruiting

Start Date:
2024-04-01

Close Date:
2025-04-30

Interventions:

DIETARY_SUPPLEMENT: alpha-lactalbumin, fructooligosaccharides, inulin
DIETARY_SUPPLEMENT: alpha-lactalbumin, sodium butyrate, fructooligosaccharides, inulin

Recruiting

Start Date:
2024-04-01

Close Date:
2025-04-30

Interventions:

DIETARY_SUPPLEMENT: alpha-lactalbumin, fructooligosaccharides, inulin
DIETARY_SUPPLEMENT: alpha-lactalbumin, sodium butyrate, fructooligosaccharides, inulin

ClinicalTrials.gov

Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy

Brief Summary: Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.

Active, not recruiting

Start Date:
2024-10-14

Close Date:
2027-07-09

Interventions:

DRUG: Cenobamate

Active, not recruiting

Start Date:
2024-10-14

Close Date:
2027-07-09

Interventions:

DRUG: Cenobamate

ClinicalTrials.gov

Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)

Brief Summary: The goal of this clinical trial is to determine if treatment of patients with two doses of ketamine plus levetiracetam versus levetiracetam alone leads to more effective control of status epilepticus.

Not yet recruiting

Start Date:
2025-08

Close Date:
2029-12

Interventions:

DRUG: Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET)
DRUG: Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET)
DRUG: Levetiracetam (LEV) (60 mg/Kg)

Not yet recruiting

Start Date:
2025-08

Close Date:
2029-12

Interventions:

DRUG: Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET)
DRUG: Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET)
DRUG: Levetiracetam (LEV) (60 mg/Kg)

ClinicalTrials.gov

Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting

Brief Summary: Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise. Secondary objectives: Comparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.

Recruiting

Start Date:
2024-11-05

Close Date:
2026-01-01

Interventions:

DEVICE: FS4 then TFS4 (cochlear implant)
DEVICE: TFS4 then FS4 (cochlear implant)

Recruiting

Start Date:
2024-11-05

Close Date:
2026-01-01

Interventions:

DEVICE: FS4 then TFS4 (cochlear implant)
DEVICE: TFS4 then FS4 (cochlear implant)

ClinicalTrials.gov

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

Brief Summary: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS).

Recruiting

Start Date:
2023-02-14

Close Date:
2027-06

Interventions:

DRUG: XEN1101
DRUG: Placebo

Recruiting

Start Date:
2023-02-14

Close Date:
2027-06

Interventions:

DRUG: XEN1101
DRUG: Placebo

ClinicalTrials.gov

Telephone-Based Support Programs for People With Epilepsy

Brief Summary: This is a two-arm randomized controlled trial to compare telephone-based depression self-management (UPLIFT) to telephone-based support groups (BOOST). A sample of 120 English- and Spanish-speaking people with epilepsy (PWE) with elevated depressive symptoms will be enrolled. Both interventions are 8-week programs delivered in one-hour weekly sessions to groups of about 6 participants. Changes in depressive symptoms, quality of life and seizures will be assessed over 12 months. The trial will also examine mediators and moderators of treatment effects.

Recruiting

Start Date:
2021-11-09

Close Date:
2026-08-31

Interventions:

BEHAVIORAL: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)
BEHAVIORAL: BOOST (Bringing Out Our Strength Together)

Recruiting

Start Date:
2021-11-09

Close Date:
2026-08-31

Interventions:

BEHAVIORAL: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)
BEHAVIORAL: BOOST (Bringing Out Our Strength Together)

ClinicalTrials.gov

Seizure Recurrence After Unprovoked First Seizure

Brief Summary: One in 10 people have a seizure during their life. Usually no cause is identified. Seizures without an identified cause are called unprovoked first seizure (UFS). Most people with UFS do not have further seizures. Being able to predict the risk of more seizures as soon as possible would help doctors decide whether to suggest treatment after UFS. Studies show that seizures are associated with changes in brain structure and function that are difficult to detect with standard assessments but can be detected with advanced techniques. Changes in connections between brain regions are also linked to subtle problems in thinking and mood. The investigators will examine brain connections using detailed brain scans, thinking, and mood in people with UFS and develop an accurate method for calculating the risk of further seizures. 200 adult patients and 75 matched healthy controls from the Halifax and Kingston First Seizure Clinics will undergo cognitive screening assessment of major cognitive domains, MRI imaging including structural scans, resting-state functional MRI (rsfMRI) and diffusion-weighted imaging (DWI), and EEG. Seizure recurrence will be assessed prospectively and a multimodal machine learning model will be trained to predict seizure recurrence at 12 months.

Recruiting

Start Date:
2023-08-01

Close Date:
2026-09

Recruiting

Start Date:
2023-08-01

Close Date:
2026-09

ClinicalTrials.gov

This Study Will Assess the Etiology, Potential Risk Factors, and Seizure Types in Patients Over 50 With Epileptic Seizure Disorder, Using Laboratory Tests, EEG, and Neuroimaging Findings.

Brief Summary: This study underscores the importance of studying the etiology, clinical characteristics, and types of epilepsy in the elderly to improve diagnosis and management in our community.

Active, not recruiting

Start Date:
2025-03-01

Close Date:
2025-10-01

Active, not recruiting

Start Date:
2025-03-01

Close Date:
2025-10-01

ClinicalTrials.gov

Natural History of Treated Neurocysticercosis and Long-Term Outcomes

Brief Summary: Neurocysticercosis is a brain disease due to the larval stage of the pork tapeworm (Taenia solium). The most common symptoms patient experience from infection inside the substance of the brain (parenchymal disease) are seizures and headaches. When the infection is either inside the fluid pockets inside the brain (ventricular disease) or in the space around the brain (subarachnoid disease) patients can have chronic headaches, relapsing aseptic meningitis, hydrocephalus, stroke, and may require neurosurgical intervention. The purpose of this study is to treat patients with anthelmintic therapy (praziquantel and/or albendazole) and anti-inflammatories in alignment with currently accepted best practices and guidelines, depending on the neurocysticercosis subtype. The purpose of the study is to better understand and characterize clinical, biologic, and management factors during treatment that influence long term outcomes. In order to understand this further we collect patient clinical information, patient survey responses, blood, urine samples, and additional cerebral spinal fluid if already being collected for clinical care....

Recruiting

Start Date:
1985-10-07

Close Date:

Recruiting

Start Date:
1985-10-07

Close Date:

ClinicalTrials.gov

A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy

Brief Summary: The purpose of this study is to assess the safety and feasibility of unilateral focused ultrasound thalamotomy in adults with focal onset epilepsy whose medicines are not working well. The ExAblate (ExAblate) transcranial system is the name of the device that will be used to create and send ultrasound waves through the scalp and skull precisely to a small structure located in the center of the brain. This structure is known as the "Anterior Nucleus", and is an important region in the brain that may cause seizures. Safety will be measured by recording and analyzing the frequency of side effects throughout participation. Feasibility will be measured by the ability to create a lesion in the anterior nucleus.

Active, not recruiting

Start Date:
2018-04-24

Close Date:
2028-05

Interventions:

DEVICE: High Intensity Focused Ultrasound

Active, not recruiting

Start Date:
2018-04-24

Close Date:
2028-05

Interventions:

DEVICE: High Intensity Focused Ultrasound

ClinicalTrials.gov

Neural Circulatory Control and SUDEP Risk.

Brief Summary: The investigators believe epilepsy alters the way the body controls blood pressure, heart rate and breathing, and these changes increase the risk of sudden unexpected death in patients with epilepsy (SUDEP). SUDEP-7 is a risk scoring tool which may correlate with these changes to the heart and blood vessels. This research study measures those differences which may help identify new markers to help predict those patients at greatest risk in the future.

Active, not recruiting

Start Date:
2016-06

Close Date:
2030-12

Active, not recruiting

Start Date:
2016-06

Close Date:
2030-12

ClinicalTrials.gov

Convulsions in Neonates With Congenital Heart Diseases

Brief Summary: analyze the etiology, electroencephalographic (EEG) findings, neuroimaging, and neurological sequalae of newborns with congenital heart disease who were presented with seizures during their neonatal intensive care unit admission.

Not yet recruiting

Start Date:
2024-08-10

Close Date:
2026-03-31

Interventions:

OTHER: Electroencephalogram (EEG), CT Brain, Echocardiogram

Not yet recruiting

Start Date:
2024-08-10

Close Date:
2026-03-31

Interventions:

OTHER: Electroencephalogram (EEG), CT Brain, Echocardiogram

ClinicalTrials.gov

Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

Brief Summary: This research is being done to evaluate the short term and long term effects of ketogenic diets on measures of cardiovascular health. Such measures include cholesterol levels, blood pressure, weight, and thickening of the blood vessel wall over time. Adults aged 18 or older who are already on a ketogenic diet for at least 12 months or who are interested in beginning on the modified Atkins diet may join.

Active, not recruiting

Start Date:
2016-03

Close Date:
2026-12

Interventions:

DIETARY_SUPPLEMENT: Modified Atkins or Ketogenic Diet

Active, not recruiting

Start Date:
2016-03

Close Date:
2026-12

Interventions:

DIETARY_SUPPLEMENT: Modified Atkins or Ketogenic Diet

ClinicalTrials.gov

PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation

Brief Summary: The goal of this observational study is to investigate how prescribed anti-seizure medications (ASMs) affect cortical excitability in adults with epilepsy. The main questions it aims to answer are: 1. Does the magnitude of transcranial magnetic stimulation (TMS)-evoked potentials (TEPs) measured with electroencephalography (EEG) change between OFF and ON medication states? 2. Do these changes in TEP amplitude persist over time? Researchers will compare each participant's measurements in the OFF state with those in the ON state to see if TEPs change following ASM (re)start. Participants will undergo one TMS-EEG session scheduled around their prescribed ASM (re)start and one 1-6 months later.

Recruiting

Start Date:
2024-10-21

Close Date:
2029-10

Interventions:

OTHER: TMS-EEG

Recruiting

Start Date:
2024-10-21

Close Date:
2029-10

Interventions:

OTHER: TMS-EEG

ClinicalTrials.gov

Anesthesia Induction Schemes of Electroconvulsive Convulsions in Patients With Depression Based on EEG Monitoring

Brief Summary: Depression is a common clinical mental disease with high incidence rate, high recurrence rate, high suicide rate and high disability rate. As a first-line treatment for depression with refractory, high suicide risk and obvious psychotic symptoms, electric shock has a definite effect on depression, but may lead to cognitive impairment. The induction of extensive epileptiform discharges in the cerebral cortex by electric shock therapy is the key to ensure the treatment effect. The level of epileptiform discharges in the brain is mainly reflected in the quality of convulsions. The quality of electroconvulsive convulsions is affected by factors such as age, stimulation power, anesthetic drugs and depth of anesthesia. Most anesthetics have anticonvulsive properties, such as barbiturate or propofol, which may have a negative impact on the quality of convulsions, thus affecting the therapeutic effect. If the parameters of electric shock, such as stimulation dose, are modified, although the quality and treatment effect of convulsions can be improved, it may also lead to higher cognitive side effects. The depth of anesthesia also affects the quality and efficacy of electric shock convulsions, and the quality of convulsions is higher when stimulated at a shallow level of anesthesia. However, if the use of narcotic drugs is reduced to improve the quality of convulsions, the risk of restlessness and delirium after electric shock may be higher and the comfort of patients may be lower. Therefore, this study compared the effects of different anesthesia induction schemes on the quality and clinical efficacy of electroconvulsive seizures in patients with depression based on EEG monitoring, and explored the optimal depth of anesthesia.

Recruiting

Start Date:
2023-06-12

Close Date:
2024-08-31

Interventions:

OTHER: Index of consciousness+Anesthetic（propofol）+Muscle relaxant（Succinylcholine）

Recruiting

Start Date:
2023-06-12

Close Date:
2024-08-31

Interventions:

OTHER: Index of consciousness+Anesthetic（propofol）+Muscle relaxant（Succinylcholine）

ClinicalTrials.gov

Early Check: Expanded Screening in Newborns

Brief Summary: Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and families who screen positive, and 3) evaluate the Early Check program. The Early Check screening will lead to earlier identification of newborns with rare health conditions in addition to providing important data on the implementation of this model program. Early diagnosis may result in health and development benefits for the newborns. Infants who have newborn screening in North Carolina will be eligible to participate, equating to over 120,000 eligible infants a year. Over 95% of participants are expected to screen negative. Newborns who screen positive and their parents are invited to additional research activities and services. Parents can enroll eligible newborns on the Early Check electronic Research Portal. Screening tests are conducted on residual blood from existing newborn screening dried blood spots. Confirmatory testing is provided free-of-charge for infants who screen positive, and carrier testing is provided to mothers of infants with fragile X. Affected newborns have a physical and developmental evaluation. Their parents have genetic counseling and are invited to participate in surveys and interviews. Ongoing evaluation of the program includes additional parent interviews.

Enrolling by invitation

Start Date:
2018-10-15

Close Date:
2025-12-31

Interventions:

DIAGNOSTIC_TEST: Confirmatory Testing

Enrolling by invitation

Start Date:
2018-10-15

Close Date:
2025-12-31

Interventions:

DIAGNOSTIC_TEST: Confirmatory Testing

ClinicalTrials.gov

A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy

Brief Summary: The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2).

Recruiting

Start Date:
2019-05-31

Close Date:
2027-12-23

Interventions:

DRUG: Perampanel Oral Suspension
DRUG: Perampanel Tablet

Recruiting

Start Date:
2019-05-31

Close Date:
2027-12-23

Interventions:

DRUG: Perampanel Oral Suspension
DRUG: Perampanel Tablet

ClinicalTrials.gov

A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures

Brief Summary: This study primarily aims to assess the efficacy and safety of zonisamide when used as an adjunctive therapy for focal epilepsy. The main questions it aims to answer are: 1. Does the frequency of epileptic seizures decrease after oral zonisamide， and does it improve cognitive function? 2. Are there any treatment-emergent adverse events associated with oral administration of zonisamide?

Recruiting

Start Date:
2024-08-01

Close Date:
2027-07-31

Interventions:

DRUG: Oral Zonisamide Therapy

Recruiting

Start Date:
2024-08-01

Close Date:
2027-07-31

Interventions:

DRUG: Oral Zonisamide Therapy

ClinicalTrials.gov

Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid 2 Pilot Trial

Brief Summary: The goal of this clinical trial is to establish the feasibility of conducting a large trial to determine the optimal timing of intravenous tranexamic acid administration in cardiac surgery. The main questions it aims to answer are: * Is it feasible to conduct a larger definitive trial? * Can we measure the systemic tranexamic acid concentration and fibrinolytic potential in the blood samples? Researchers will compare intravenous tranexamic acid administered before cardiopulmonary bypass versus after cardiopulmonary bypass to see if the systemic tranexamic acid concentration and fibrinolytic potential are similar or better. Participants will: * Provide written informed consent * Receive tranexamic acid during surgery * Provide blood samples at 5 time points: before surgery, on arrival in intensive care unit, 3 hours after arrival, 6 hours after arrival, and on the next morning.

Not yet recruiting

Start Date:
2025-01-01

Close Date:
2026-02-01

Interventions:

DRUG: Before CPB Tranexamic Acid
DRUG: After CPB Tranexamic Acid
DRUG: Before CPB Placebo
DRUG: After CPB Placebo

Not yet recruiting

Start Date:
2025-01-01

Close Date:
2026-02-01

Interventions:

DRUG: Before CPB Tranexamic Acid
DRUG: After CPB Tranexamic Acid
DRUG: Before CPB Placebo
DRUG: After CPB Placebo

ClinicalTrials.gov

Epilepsy Watch After Vascular Events: Frequency, Outcomes, and Risk Markers

Brief Summary: This research aims to determine the frequency of seizures in patients following a stroke, identify risk factors associated with post-stroke seizures, and characterize EEG changes linked to these seizures. Unexplored alterations in the aperiodic component of the EEG in post-stroke patients could potentially serve as novel biological markers for epilepsy after stroke.

Active, not recruiting

Start Date:
2014-11-01

Close Date:
2025-12-31

Active, not recruiting

Start Date:
2014-11-01

Close Date:
2025-12-31

ClinicalTrials.gov

Effects of Mega-dose Vitamin D Pulse and Maintenance Therapy on Seizure Frequency, Fatigue, and Quality of Life: a Prospective Study

Brief Summary: We inform consent overall process of this trial study through face-to-face use of the IRB, clarify patient questions, and allow subjects to fully understand the trial study.

Not yet recruiting

Start Date:
2025-01-01

Close Date:
2026-12-31

Interventions:

OTHER: Vitamin D
OTHER: Placebo

Not yet recruiting

Start Date:
2025-01-01

Close Date:
2026-12-31

Interventions:

OTHER: Vitamin D
OTHER: Placebo

ClinicalTrials.gov

Investigating Epilepsy: Screening and Evaluation

Brief Summary: Background: Epilepsy affects about 1 percent of the U.S. population. Most people with epilepsy respond well to medicine, but some do not. Researchers want people who have diagnosed or suspected epilepsy to participate in ongoing studies. They want to learn more about clinical care for epilepsy. They want fellows and residents to learn more about the care of people with epilepsy. Objectives: To learn more about seizures and find ways to best treat people with drug-resistant epilepsy. Eligibility: Adults and children ages 8 years and older with diagnosed or suspected epilepsy Design: Participants will be screened with: Physical exam Medical history Questionnaires Participants will have many visits. They may be admitted to the hospital for several weeks. Their medication might be stopped or changed. Participants will have many tests: Blood and urine tests EEG: Wires attached to the head with paste record brain waves. This may be videotaped. Thinking and memory tests MRI: Participants lie on a table that slides in and out of a tube. They perform simple tasks in the tube. MEG: Participants lie on a table and place their head in a helmet to record brain waves. PET scan: Participants lie on a table that slides into a machine. A small amount of radioactive dye is injected into their arm with an IV. For the IV, a small tube is inserted into the arm with a needle. Participants will stay enrolled in this study if they join other epilepsy-related studies. They may be contacted at intervals for follow-up. Their participation will end if they have not been seen clinically for their epilepsy for 3 years.

Recruiting

Start Date:
2018-03-28

Close Date:
2027-07-30

Recruiting

Start Date:
2018-03-28

Close Date:
2027-07-30

ClinicalTrials.gov

Genotype, Phenotype, and Disease Progression of Developmental Epileptic Encephalopathy With Onset Before 2 Years of Age

Brief Summary: According to estimates by the World Health Organization in 2019, more than 50 million people around the world have epilepsy. Nearly 80% of patients with epilepsy live in developing countries. Among them, children under 2 years old are the group with the highest incidence of epilepsy, and at the same time, the most dangerous epilepsy groups are also likely to start at these ages. World medical literature on epileptic encephalopathy and early-onset development before 2 years of age records that 71% of children have severe intellectual disability and 60% of children show signs of autism spectrum disorder, of which Children with epileptic and developmental encephalopathy due to genetic causes are at higher risk of developing neurodevelopmental disorders than children with epileptic and developmental encephalopathy due to other causes. However, in Vietnam, there is no research on this topic. The question is what are the phenotypes, genotypes, and progression after 2 years of follow-up of Vietnamese children with epileptic and developmental encephalopathy with onset before 2 years of age?

Recruiting

Start Date:
2024-02-27

Close Date:
2028-11-01

Recruiting

Start Date:
2024-02-27

Close Date:
2028-11-01

ClinicalTrials.gov

Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy

Brief Summary: Approximately a fourth of children with seizures do not respond adequately to available therapy. Ketogenic therapy has a long history as treatment for intractable epilepsy, but there is no agreement concerning how it works and what is the best way to administer it. This natural history study will collect data pertaining to both questions.

Recruiting

Start Date:
2006-09

Close Date:
2031-10

Interventions:

DIETARY_SUPPLEMENT: Ketogenic Therapy

Recruiting

Start Date:
2006-09

Close Date:
2031-10

Interventions:

DIETARY_SUPPLEMENT: Ketogenic Therapy

ClinicalTrials.gov

Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults

Brief Summary: The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).

Recruiting

Start Date:
2022-04-28

Close Date:
2028-12

Interventions:

DRUG: Carisbamate

Recruiting

Start Date:
2022-04-28

Close Date:
2028-12

Interventions:

DRUG: Carisbamate

ClinicalTrials.gov

Epilepsy Learning Healthcare System (ELHS)

Brief Summary: The Epilepsy Learning Health System (ELHS) is a quality improvement and research network to improve outcomes for people with epilepsy. The ELHS is designed as a model of value-based chronic care for epilepsy as envisioned by the National Academies of Medicine Committee in their landmark reports "The Learning Health System" and "Epilepsy Across the Spectrum: Promoting Health and Understanding". The ELHS network is a collaboration among clinicians, patients and researchers that promotes the use of data for multiple purposes including one-on-one clinical care, population management, quality improvement and research. The ELHS Registry includes data on children and adults with epilepsy collected during the process of standard epilepsy care. These data are used to create population health reports and to track changes in outcomes over time. ELHS teams use quality improvement methods, such as Plan-Do-Study-Act (PDSA) cycles, to continuously learn how to improve care.

Recruiting

Start Date:
2019-03-20

Close Date:
2099-02-14

Interventions:

OTHER: Clinical care and quality improvement

Recruiting

Start Date:
2019-03-20

Close Date:
2099-02-14

Interventions:

OTHER: Clinical care and quality improvement

ClinicalTrials.gov

A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)

Brief Summary: This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DEE. The study consists of 3 main phases: Screening, Titration period, Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 24 months.

Recruiting

Start Date:
2024-11-11

Close Date:
2026-11-30

Interventions:

DRUG: LP352
DRUG: Placebo

Recruiting

Start Date:
2024-11-11

Close Date:
2026-11-30

Interventions:

DRUG: LP352
DRUG: Placebo

ClinicalTrials.gov

A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures

Brief Summary: This study is being done to help scientists learn about the use of a device called an atomic magnetometer. The device uses sensors called optically-pumped magnetometers (OPM) which function at room temperature. This research will compare the non-invasive brain imaging application of the OPM sensors to the present SQUID-based cryogenic sensor technique used in conventional Magnetoencephalography (MEG). This study is being conducted in conjunction with the University of Colorado Boulder's Mechanical Engineering Department.

Recruiting

Start Date:
2021-03-01

Close Date:
2025-12-31

Interventions:

DEVICE: OPM sensors
DEVICE: SQUID sensors

Recruiting

Start Date:
2021-03-01

Close Date:
2025-12-31

Interventions:

DEVICE: OPM sensors
DEVICE: SQUID sensors

ClinicalTrials.gov

Pharmacological Management of Seizures Post Traumatic Brain Injury

Brief Summary: The overall aim of the MAST trial is to define best practice in the use of anti-epileptic drugs (AEDs) for patients following a traumatic brain injury (TBI). The trial will consist of two parts. The first part aims to answer whether a shorter or a longer course of AEDs is better to prevent further seizures in patients who have started having seizures following TBI (MAST - duration). The second part aims to answer whether a 7-day course of either Phenytoin or Levetiracetam should be used for patients with a serious TBI to prevent seizures from starting (MAST- prophylaxis).

Not yet recruiting

Start Date:
2021-03-01

Close Date:
2028-03-01

Interventions:

DRUG: Phenytoin Sodium
DRUG: Levetiracetam

Not yet recruiting

Start Date:
2021-03-01

Close Date:
2028-03-01

Interventions:

DRUG: Phenytoin Sodium
DRUG: Levetiracetam

ClinicalTrials.gov

Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES

Brief Summary: The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C) pain tolerance (time with hand in water) and cortisol response. Target assessments will occur 7 days before treatment, 7 days after 8th treatment session and 7 days after 12th treatment session. Participants will also complete long term follow-up visits via HIPAA-compliant Zoom at 6 months and 12 months after the 12th treatment session where participants will complete questionnaires. PNES frequency will be measured from 30 days before to 12 months after treatment.

Recruiting

Start Date:
2021-10-28

Close Date:
2026-12-31

Interventions:

BEHAVIORAL: ReACT

Recruiting

Start Date:
2021-10-28

Close Date:
2026-12-31

Interventions:

BEHAVIORAL: ReACT

ClinicalTrials.gov

Effect of Febrile Convulsion Training on Anxiety and Knowledge

Brief Summary: The research will be conducted to determine the effect of the training given to parents/caregivers on their knowledge, attitudes, practices and anxiety towards preventing febrile seizures in children. The research will be carried out as a randomised controlled experimental design in the Pediatric Emergency Department of Zeynep Kamil Women's and Children's Diseases Training and Research Hospital between October 2024 and October 2025.

Not yet recruiting

Start Date:
2024-11-30

Close Date:
2025-11-30

Not yet recruiting

Start Date:
2024-11-30

Close Date:
2025-11-30

ClinicalTrials.gov

Scleral Lens Fitting Using Wide-Field OCT

Brief Summary: The purpose of this study is to see if OCT technology can optimize scleral contact lens fittings. Subjects with keratoconus, post-penetrating keratoplasty (PK), post-LASIK ectasia, post-radial keratotomy (RK), or a variety of anterior surface disorders requiring scleral lens fittings will be considered for enrollment. For each study eye, a clinically-selected scleral lens fit will be compared against an OCT-selected lens fit. The quality of each lens fit will be determined by flourescein exam at the slit lamp. Apical clearance, limbal clearance, conjunctival compression, and lens edge lift will be assessed. A lens that satisfies all four criteria will be considered satisfactory.

Recruiting

Start Date:
2020-09-23

Close Date:
2028-12

Recruiting

Start Date:
2020-09-23

Close Date:
2028-12

ClinicalTrials.gov

Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a New Diagnosis

Brief Summary: This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and alerting system for Veterans with a history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization, taking place in the home setting.

Active, not recruiting

Start Date:
2018-11-02

Close Date:
2026-01

Interventions:

DEVICE: SPEAC System

Active, not recruiting

Start Date:
2018-11-02

Close Date:
2026-01

Interventions:

DEVICE: SPEAC System

ClinicalTrials.gov

Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs

Brief Summary: Epilepsy, a prevalent neurological disorder, affects 40% of patients with uncontrolled seizures despite medications. Sleep disturbance exacerbates epilepsy, and vice versa, but existing literature suffers from limitations. Studies conducted in hospital settings provide only brief observation periods and fail to capture the natural sleep environment. Wearable technology offers a promising solution, providing a nuanced understanding of the relationship between seizures and sleep. The Dreem headband, an EEG-based wearable, is well-suited for such studies, offering ease of use and validated accuracy. This technology enables extended observation periods under stable medication conditions, essential for assessing the complex interplay between sleep and epilepsy. By elucidating the impact of sleep on seizures, the researchers seek to identify patient populations where sleep significantly influences seizure susceptibility, ultimately informing personalized epilepsy treatments.

Not yet recruiting

Start Date:
2025-10-01

Close Date:
2028-03-01

Interventions:

DEVICE: Dreem headband

Not yet recruiting

Start Date:
2025-10-01

Close Date:
2028-03-01

Interventions:

DEVICE: Dreem headband

ClinicalTrials.gov

Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a Recent Non-diagnostic EMU Visit

Brief Summary: This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and alerting system for Veterans with seizures with upper extremity motor involvement, who have had a recent non-diagnostic EMU stay.

Not yet recruiting

Start Date:
2020-07-01

Close Date:
2026-01

Interventions:

DEVICE: SPEAC System

Not yet recruiting

Start Date:
2020-07-01

Close Date:
2026-01

Interventions:

DEVICE: SPEAC System

ClinicalTrials.gov

Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults

Brief Summary: The aim of this clinical trial is to evaluate the effectiveness and user satisfaction of remote fine-tuning of hearing aids compared to traditional face-to-face adjustments. The main questions aims to answer: \- Are hearing aid outcomes (self-reported and objective) similar when using remote fine-tuning compared to face-to-face adjustments? Researchers will compare remote fine-tuning (using a smartphone app) to traditional face-to-face fine-tuning sessions in a clinical setting. Participants will: * Be randomized to either the remote fine-tuning group (intervention group) or the face-to-face adjustment group (control group). * Attend five scheduled consultations over a 3-month period, including baseline measurements, hearing aid fittings, and follow-up visits. Participants in the remote fine-tuning group will: \- Set up and use a hearing aid manufacturer's smartphone app to complete fine-tuning sessions from home. Participants in the face-to-face group will: \- Visit the clinic for in-person fine-tuning appointments. Data will be collected through questionnaires (e.g., SSQ-12, IOI-HA, and COSI) and objective measures such as the Speech Intelligibility Index (SII) and speech comprehension in noise (DS-FF). Additional qualitative data will be gathered from interviews with participants in the remote fine-tuning group.

Recruiting

Start Date:
2025-05-27

Close Date:
2026-03-30

Interventions:

DEVICE: Remote fine-tuning of hearing aids
DEVICE: Face-to-face fine-tuning of hearing aids

Recruiting

Start Date:
2025-05-27

Close Date:
2026-03-30

Interventions:

DEVICE: Remote fine-tuning of hearing aids
DEVICE: Face-to-face fine-tuning of hearing aids

ClinicalTrials.gov

A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus)

Brief Summary: This is a parallel arm non-randomized dose-escalation, open-label basket exploratory phase 1 clinical trial where Mitochondrial encephalopathy, lactic acidosis, stroke-like episodes (MELAS) and Leber's hereditary optic neuropathy-Plus (LHON-Plus) participants will undergo simultaneous enrollment in two disease-based arms and receive daily oral doses of glycerol tributyrate to assess its safety and potential for efficacy using clinical, biochemical, and molecular evidence. This study will utilize a two-month baseline lead-in phase to establish and document the clinical baseline for each participant in both arms in order to compare the molecular and clinical parameters. This is clinically relevant in light of the high clinical heterogeneity among subjects affected by the same mitochondrial disease (MELAS or LHON-Plus). For ethical concerns prompted by the lack of treatment for these two intractable and progressive mitochondrial diseases, there will not be a placebo control group. Thus, each participant will act as their own control and receive oral doses of glycerol tributyrate, eliminating the need for a placebo. Considering the high clinical heterogeneity among participants affected by MELAS or LHON-Plus and some clinical divergence between MELAS and LHON-Plus, this strategy is beneficial to every enrolled participants, as each will receive the investigational drug, glycerol tributyrate. In addition, this approach will determine the subject-specific maximal optimized dose in a personalized medicine-based approach. After approval of the IRB protocol from the Institutional Review Board Data and signed consent form from all participants, this investigational basket clinical trial has three phases spanning over 20 months: * A baseline lead-in phase (2 months) to collect participant-specific baseline for clinical, biochemical, molecular and metabolic biomarkers that will be monitored throughout the subsequent dose-escalation and clinical phases. * A dose-escalation phase (6 months) to determine the participant-specific maximum tolerated dose (MTD) during which participant-specific clinical and biochemical biomarkers are collected every month. * A clinical phase at a fixed subject-specific MTD dose (12 months) to collect participant-specific clinical, biochemical, molecular and metabolic biomarkers and to perform three scheduled skin biopsies: at the outset, mid-point, and the end of this clinucal phase. We have planned for a 12-month-long clinical phase at a fixed participant-specific MTD considering the absence of reliable predictors that makes idiosyncratic disease-specific symptoms for MELAS and LHON-Plus impossible to forecast among participant for assessing the potential efficacy of glycerol tributyrate by monitoring clinical symptoms specific for each disease. During the 12-month-long time-frame, disease-specific clinical symptoms will be collected as preliminary evidence of efficacy of glycerol tributyrate using disease-specific biomarkers. Finally, discharge procedure during which the clinical investigator will record non-serious adverse events or serious adverse events for 7 or 30 days, respectively, after the last day of study participation.

Recruiting

Start Date:
2025-09

Close Date:
2026-10-02

Interventions:

DRUG: Glycerol Tributyrate

Recruiting

Start Date:
2025-09

Close Date:
2026-10-02

Interventions:

DRUG: Glycerol Tributyrate

ClinicalTrials.gov

Short Versus Long-term Levetiracetam in Brain Tumors

Brief Summary: Levetiracetam is the commonly preferred anti-seizure medicine in patients with brain tumors. This drug has reduced the risk of seizure events occurring but is associated with a risk of side effects such as increased headache, drowsiness, loss of muscle coordination, and psychological challenges in patients. In patients undergoing appropriate treatment for brain tumors and controlled of seizures in the initial few months of levetiracetam, the chance of further seizures is relatively low. The optimal duration to give levetiracetam is not well defined for these patients, and currently as standard treatment levetiracetam is continued for 2-3 years. This study aims to answer this question by comparing patients on a short course of levetiracetam (experimental arm) versus a longer course of levetiracetam (standard arm), with the anticipation that a shorter duration of treatment will not lead to increased seizure episodes.

Recruiting

Start Date:
2024-07-04

Close Date:
2031-06-01

Interventions:

DRUG: Levetiracetam

Recruiting

Start Date:
2024-07-04

Close Date:
2031-06-01

Interventions:

DRUG: Levetiracetam

ClinicalTrials.gov

Effects of Associated Impairments on Activity and Participation in Children With Cerebral Palsy

Brief Summary: This study will investigate the effects of associated impairments on the activity levels and social participation of school-aged children with Cerebral Palsy (aged 6-12) and their impact on their families' quality of life and caregiving burden.

Recruiting

Start Date:
2024-10-01

Close Date:
2025-06-27

Recruiting

Start Date:
2024-10-01

Close Date:
2025-06-27

ClinicalTrials.gov

Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation

Brief Summary: A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation.

Active, not recruiting

Start Date:
2023-11-01

Close Date:
2024-12-31

Interventions:

DIAGNOSTIC_TEST: Early Rehab
COMBINATION_PRODUCT: Delayed Rehab

Active, not recruiting

Start Date:
2023-11-01

Close Date:
2024-12-31

Interventions:

DIAGNOSTIC_TEST: Early Rehab
COMBINATION_PRODUCT: Delayed Rehab

ClinicalTrials.gov

A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures

Brief Summary: The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly greater than 60mg/kg. This study will be an open label dose-escalation, preliminary safety and efficacy study. There will be a randomized control treatment component. Infants recognized as having neonatal seizures or as being at risk of developing seizures will be recruited and started on continuous video EEG monitoring (CEEG). Eligibility will be confirmed and consent will be obtained. In the first 2 phases of the study, neurologists will identify neonates with mild-moderate seizure burden (less than 8 minutes cumulative seizure activity per hour), appropriate for study with LEV, and exclude patients with higher seizure burden where treatment with PHB is more appropriate. Phase 3 of the dose escalation will only proceed if additional efficacy of LEV has been demonstrated in phases 1 and 2. In Phase 3 we will recruit neonates with seizures of greater severity up to 30 minute seizure burden/hour. This will make the final results of study more generalizable. If seizures are confirmed, enrolled subjects will receive 60mg/kg of LEV. Subjects whose seizures persist or recur 15 minutes after the first infusion is complete, subjects will then be randomized in the dose escalation study. Patients in the dose escalation study will be randomly assigned to receive either higher dose LEV or treatment with the control drug PHB in a 3:1 allocation ratio, stratified by site. Funding Source- FDA OOPD

Recruiting

Start Date:
2023-03-24

Close Date:
2027-12-31

Interventions:

DRUG: Levetiracetam Injection
DRUG: Phenobarbital Sodium Injection

Recruiting

Start Date:
2023-03-24

Close Date:
2027-12-31

Interventions:

DRUG: Levetiracetam Injection
DRUG: Phenobarbital Sodium Injection

ClinicalTrials.gov

Long-Term Follow-Up of a Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting

Brief Summary: This is a multi-center, non-interventional and prospective study of patients receiving Epidyolex as part of standard clinical practice in France. The study will state an overview of patient characteristics and clinical history (including age, sex, diagnosis, duration of epilepsy, predominant seizure type, previous medications, current co-medications and Epidyolex dose), and an evaluation of retention rates, safety profile, seizure activity, changes in executive function and quality of life measured in a 2-year follow-up period.

Active, not recruiting

Start Date:
2023-04-17

Close Date:
2026-07

Interventions:

DRUG: Epidiolex

Active, not recruiting

Start Date:
2023-04-17

Close Date:
2026-07

Interventions:

DRUG: Epidiolex

ClinicalTrials.gov

Embrace: Seizure Characterization

Brief Summary: The study is intended to characterize sleep, stress, and seizures in daily life with the Empatica Embrace watch and smartphone-based diary-alert system. The primary study objective is to collect and validate biometric signals from epilepsy patients using the Empatica Embrace watch and compare them to ictal events captured from human (patient and caregiver) reports.

Enrolling by invitation

Start Date:
2016-05

Close Date:
2026-05

Interventions:

DEVICE: Embrace + Alert App

Enrolling by invitation

Start Date:
2016-05

Close Date:
2026-05

Interventions:

DEVICE: Embrace + Alert App

ClinicalTrials.gov

Retraining and Control Therapy (ReACT)- Adults

Brief Summary: The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of adult psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no correlated epileptiform activity). 19 years and older participants diagnosed with PNES who are treated at UAB FND clinic will engage in twelve sessions of ReACT. Participants will be randomly assigned to one of three conditions: no wait, 3-month waiting period, 6-month waiting period. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale (PCS), pain tolerance (time with hand in water) and cortisol response. Target assessments occur 7 days before treatment and 7 days after the 12th treatment session. Participants randomized to the 3-month and 6-month waiting period will also complete these measures one additional time immediately before the beginning of their waiting period. Long term follow-up assessments will occur at 2 months, 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment. Participants randomized to the 3-month or 6-month waiting period conditions will log weekly PNES episodes until the start of therapy.

Recruiting

Start Date:
2025-04-10

Close Date:
2027-12-31

Interventions:

BEHAVIORAL: ReACT

Recruiting

Start Date:
2025-04-10

Close Date:
2027-12-31

Interventions:

BEHAVIORAL: ReACT

ClinicalTrials.gov

Improving Diagnostics and Care After First Seizure

Brief Summary: A first epileptic seizure is a distressing experience, often leading to a complicated and discouraging journey before an epilepsy diagnosis is confirmed. Early diagnostics can help alleviate this uncertainty. It is important to note that seizure mimics and suspected epilepsy are more frequently encountered than an actual first diagnosis of epilepsy or an epileptic seizure. Conversely, delays in diagnosing epilepsy are also common. The current evidence base on first events that may be epileptic remains limited. First seizure clinics, which provide specialized care for these cases, are becoming more common globally, but none have yet been established in Norway. There is a pressing need to assess the prevalence of first-seizure-like events in Bergen and the surrounding areas, as well as to investigate the clinical trajectory before and after an epilepsy diagnosis. EEG is the cornerstone of diagnostic testing for epilepsy after first seizure, and recent advancements have introduced artificial intelligence to enhance the accuracy of EEG-based epilepsy identification. The investigators will identify in one year around 200 hospital-handled patients who had had an episode that may be epileptic. Patient will be followed up over two years, with data abstracted from the medical record regarding seizure diagnosis, new events, new brain-related diagnoses and complications. Data will also be gathered from government databases in primary and secondary care regarding complications from seizure, new brain-related diagnoses, new brain-related medications, sickness absence and income. For children, school absence days will be collected. The investigators will identify the incidence of first seizure and new-onset epilepsy, and and which care pathways most patients with suspected first seizure go through. The investigators will study the role of early EEG to reduce diagnostic uncertainty, and compare conventional EEG interpretation with AI-assisted interpretation for diagnostic precision. The investigators will study the trajectory of anxiety, quality of life and complications with record linkage for epilepsy-relevant outcomes. A broad scope of complications will be studied, including job or school absence, driving license status, injuries in primary or secondary care, and new brain-related diagnoses. This study will gather important data to gauge potential gaps and improvements in care in early epilepsy, of relevance to patients in Bergen, Norway and the developed part of the world. Particulary novel aspects are an evaluation of the SCORE AI model for EEG analysis, and linking to a spectrum of government databases on work participation, primary care and specialty care on complications of first seizure and/or early epilepsy.

Recruiting

Start Date:
2025-01-24

Close Date:
2029-01-24

Recruiting

Start Date:
2025-01-24

Close Date:
2029-01-24

ClinicalTrials.gov

Seizure Treatment in Glioma

Brief Summary: Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians' preference, as there are no studies supporting the use of one specific anticonvulsant in glioma patients. The overall aim of this randomized controlled trial is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure.

Recruiting

Start Date:
2018-02-01

Close Date:
2028-07-01

Interventions:

DRUG: Levetiracetam
DRUG: Valproic Acid

Recruiting

Start Date:
2018-02-01

Close Date:
2028-07-01

Interventions:

DRUG: Levetiracetam
DRUG: Valproic Acid

ClinicalTrials.gov

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