Have You Ever Been Diagnosed with Focal-Onset (or Partial-Onset) Epilepsy? If so, you may be able to participate in Xenon’s Focal-Onset Epilepsy Clinical Study!
Participants will receive investigational study medication for focal-onset epilepsy, study-related care from a study doctor and study related travel support.
The TSC Biosample Repository stores samples of blood, DNA, and tissues scientists can use in their research. The samples we collect are all linked to clinical data in the TSC Natural History Database. These samples and data about individuals who provided samples help researchers discover biomarkers of TSC, test potential drug treatments, and determine why TSC is so different from person to person.
Implemented in 2006, the TSC Natural History Database captures clinical data to document the impact of the disease on a person’s health over his or her lifetime. More than 2,000 people with TSC are enrolled in the project among 18 U.S.-based clinical sites. The TS Alliance provides funding to participating clinics to perform data entry, monitors the integrity of the database, and makes data available to investigators to answer specific research questions and identify potential participants for clinical trials and studies.
Description: Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled, double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis Complex who are less than 6 months of age prior to the onset of their first seizure.
Description: The purpose of the study is to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for necrotization or coagulation of epileptogenic foci in patients with intractable mesial temporal lobe epilepsy.
The study will include approximately 150 adult patients with drug-resistant MTLE treated at selected epilepsy centers across the United States. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events, and neuropsychological outcomes.
Some of the listings above may be sponsored content.
10 Search Results
All studies below are either currently recruiting or will be soon.
Objective EEG Bed Side Assessment of Impaired Conscious Awareness in Epilepsy
In this project EEG recordings between healthy participants and those with a diagnosed
Absence-epilepsy will be compared. The investigators suggest differences in EEG microstate
analysis and neuropsychological parameters related to interictal cognitive impairment in
these patients. This projects goal is to derive an EEG-based measure of conscious awareness.
Start Date: June 2021
Close Date: June 2024
Self-management for People With Epilepsy
SMART is a program for adult individuals with sub-optimally controlled epilepsy. It involves
educational and behavioral interventions intended to enhance epilepsy self-management.
The initial group session is in-person where individuals receive curriculum materials and
learn to utilize the Web format (such as Adobe Connect or ZOOM) and a teleconferencing
service needed to access the remainder of the group sessions. These sessions are held over an
8 week time period and are co-lead by a trained nurse educator and a trained peer educator.
The peer educator is someone with epilepsy and a history of NHEs. Educators use a written
curriculum delivered online, and the interactive sessions last 60-90 minutes. Groups are
limited to about 6 -12 adult participants.
After the group sessions are done, individuals have 8 telephone maintenance sessions with the
nurse educator and the peer educator spaced approximately 2 weeks apart.
SMART is intended for adults with epilepsy, especially those who belong to disadvantaged sub
groups such as rural populations, veterans with epilepsy and those who are underinsured.
People with epilepsy who belong to disadvantaged sub-groups are more likely to have poor
outcomes and often end up using expensive crisis-oriented care, and thus potentially might
benefit the most from self-management programs if they can be actively engaged.
Start Date: May 15, 2021
Close Date: December 2024
Behavioral: SMART 2
Evaluation of Memory and Forgetting in Patients With Epilepsy
Drug-resistant focal epilepsy (DRFE) is frequently associated with complications of varying
severity that impair patient's quality of life. Among these complications, cognitive
disturbances and especially episodic memory difficulties, play a determinant part. Episodic
memory can be defined as a function that allows the mental reconstruction of a past life
episode, through complex associative mechanisms that link the vivid experience to its context
of occurrence, called encoding context. It is a dynamic cognitive function, which calls on a
widely distributed cerebral network, mainly involving the medial temporal lobe, particularly
the hippocampus. Epilepsy could have a specific impact on this crucial network, disrupting
the binding mechanisms between the experienced events and their encoding context, which are
essential for efficient memory. Although patients with DRFE frequently demonstrate memory
impairment as assessed by standardised neuropsychological tests, it only imperfectly reflects
their difficulties. As a matter of fact, despite a subjective memory complaint, about 20%
have no memory impairment on these tests, resulting from a phenomenon called accelerated
long-term forgetting (ALF). ALF is indeed characterised by normal performance on standardised
neuropsychological tests involving retention delays of 20-30 minutes, but disabling memory
complaint and abnormally marked forgetting within hours or days that follow the learning
period. This phenomenon is widely described at the conceptual level, but remains difficult to
measure in daily practice, at least partly due to methodological limits. Thus, the validated
tools available in clinical routine are poorly adapted to the complexity and the associative
dimension of memory networks. There is therefore a clinical need for a specific assessment
tool that would be able to detect ALF, in order to better quantify it and to enable the
appropriate care of patients suffering from DRFE. The aim of the EPIMNESIE study is to
evaluate the diagnostic capacity of a behavioural associative memory task, based on the
analysis of encoding and consolidation mechanisms, in order to measure ALF. In this
prospective study, 40 patients with DRFE and 40 healthy subjects will be proposed to complete
a new associative memory task involving a learning phase and two recall sessions which will
take place at 30 minutes and 72 hours after the learning phase.
Start Date: September 1, 2021
Close Date: November 1, 2023
Diagnostic Test: Computerised associative memory task using abstract words and landscape photographs
Pulvinar Stimulation in Epilepsy: a Pilot Study
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.
Start Date: January 15, 2021
Close Date: January 15, 2025
Device: Pulvinar deep brain stimulation
The Diagnostic Value of Autoimmune Antibody Detection in Newly Onset and Chronic Epilepsy
multi-central and prospectively study the diagnostic value of autoimmune antibody detection
in new and chronic epilepsy, and provide reference for clinical practice
Start Date: August 2020
Close Date: September 2021
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study
that will evaluate the clinical efficacy, safety and tolerability of increasing doses of
XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy,
followed by an optional open-label extension (OLE).
Start Date: January 30, 2019
Close Date: June 2022
Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?
The purpose of this study is to evaluate standard of care exercise education alone or in
combination with a wearable physical activity tracker in people with epilepsy (PWE) to
determine the most effective way to increase physical activity and measure impact on
depression, anxiety, quality of life, sleep, and seizure frequency.
Start Date: June 16, 2020
Close Date: June 16, 2021
Behavioral: Activity Tracker Group
Behavioral: Standard of Care Group
Prospective Regional Epilepsy Database
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.
Start Date: December 15, 2020
Close Date: December 31, 2031
Other: Seizure status
Diagnostic Test: Tests
Other: Demographics and psychosocial
Other: Health care
Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy
The purpose of this study is to evaluate the pharmacokinetics (PK) of perampanel during the
Maintenance Period of the Core Study following oral suspension administration given as an
adjunctive therapy in pediatric participants from 1 month to less than 4 years of age with
Start Date: February 20, 2017
Close Date: November 9, 2022
Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy
This project aims to conduct a pilot study based on the targeting of the epileptogenic zone
previously localized very precisely by stereoelectroencephalography (SEEG). SEEG is used as
part of the pre-surgical assessment. It consists, thanks to the intracerebral implantation of
electrodes in the brain of patients, to perform an intracerebral electrophysiological
recording and thus to precisely explore the epileptogenic regions.
In order to study the neuromodulatory and therapeutic effects of tDCS on epileptic brains,
non-invasive techniques for measuring electrophysiological brain activity such as
magnetoencephalography (MEG) and high-resolution electroencephalography (HR EEG) will be
Finally, since epilepsy is considered to be a disorder of brain functional networks
associated with disturbed brain connectivity, the effects of tDCS on cortical excitability by
studying the variations in functional connectivity induced by stimulation will be studied.