Clinical trials: Focal Drug-resistant Epilepsy
Drug-Resistant Focal Epilepsy
Temporal Interference Brain Stimulation for Adults With Drug-Resistant Epilepsy Undergoing Stereo-EEG Monitoring
This study evaluates whether a non-invasive brain stimulation technique called Temporal Interference (TI) can reduce epilepsy-related abnormal brain activity and influence sleep-related brain rhythms in adults with focal…
- Trial name
- NCT07764718
- Testing
- Temporal Interference Stimulation, Direct Electrical Stimulation
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Duke University
Epilepsy, Drug-resistant Focal Epilepsy
Impact of Epilepsy on the Brainstem Adenosine Pathway and Its Relation With Arousal and Respiratory Reactivity
Despite the continuous development of new antiseizure medications over the past 25 years, 30% of patients with epilepsy suffer from drug-resistant seizures and are at risk of epilepsy-related complications, like cognitive…
- Conditions
- Epilepsy, Drug-resistant Focal Epilepsy, Healthy Controls
- Trial name
- BRAVE (NCT07249034)
- Testing
- 1 Hypercapnic challenge while participant is awake, PET/MRI acquisition
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Focal Epilepsy
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
- Trial name
- RISE 2 (NCT06132893)
- Testing
- BHV-7000
- Where
- 104 sites in United States, Argentina and 10 more
- Volunteers
- 390 people
- Sponsor
- Biohaven Therapeutics Ltd.
Focal Epilepsy, Generalized Seizure
Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables
Mayo Clinic is conducting a research study to test a new approach to managing seizures in people with epilepsy whose seizures have not been fully controlled with regular medications.
- Conditions
- Focal Epilepsy, Generalized Seizure, Drug Refractory Epilepsy
- Trial name
- FORESITE (NCT07012148)
- Testing
- UNEEG SubQ device, seizure forecasts, nasal diazepam, Preventative Medication (PM)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Mayo Clinic
Focal Epilepsy, Drug-resistant Focal Epilepsy
RNS System for Drug-Resistant Focal Epilepsy in Adolescents: A Real-World Study
The NeuroPace RNS System is FDA-approved for adults with drug-resistant focal epilepsy but is not yet approved for adolescents. This study uses real-world data to evaluate the RNS System's safety and effectiveness in adolescents…
- Trial name
- AURORA (NCT07823465)
- Testing
- NeuroPace RNS System
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- NeuroPace
Drug Resistant Epilepsy, Epilepsy
A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy
This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in…
- Conditions
- Drug Resistant Epilepsy, Epilepsy, Seizures, Focal, Seizure
- Trial name
- NCT06388707
- Testing
- NaviFUS System
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- NaviFUS Corporation
Drug-Resistant Focal Epilepsy
EASEE® System Pivotal Study for the United States of America
The goal of this clinical trial is to demonstrate the safety and effectiveness of focal cortex stimulation with the EASEE(R) System in a large cohort of subjects with medically refractory focal epilepsy.
- Trial name
- EASEE4US (NCT07301346)
- Testing
- Implantable minimaly invasive brain stimulator
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Precisis US, Inc.
Focal Epilepsy
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
- Trial name
- RISE 3 (NCT06309966)
- Testing
- BHV-7000
- Where
- 150 sites in United States, Australia and 14 more
- Volunteers
- 390 people
- Sponsor
- Biohaven Therapeutics Ltd.
Focal Drug-resistant Epilepsy
Multimodal Study of the Human Brain Epilepsy Tissue
The TIPI2 study is a blood and tissue collection protocol to create an annotated biorepository to support research in drug-resistant epilepsy. The aim of the study will be to identify new pathophysiological pathways.
- Trial name
- TIPI² (NCT06022055)
- Testing
- Blood and tissue collection
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Drug-Resistant Epilepsy, Epilepsy
Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy
The goal of this study is to investigate the effects of a non-invasive, low intensity focused ultrasound (LIFU) stimulation on seizure frequency and the epileptogenic network in drug-resistant epilepsy.
- Conditions
- Drug-Resistant Epilepsy, Epilepsy, Epilepsy (Treatment Refractory), Epilepsy Comorbidities
- Trial name
- NCT07680842
- Testing
- Target optimization using LIFU, Serial LIFU stimulation
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Francisco
Drug Resistant Epilepsy
Fluorescence Guided Focal Cortical Dysplasia Surgery
Epilepsy is one of the most common neurological disorders, with one of the highest morbidity rates of all diseases. Despite the development of new anticonvulsant drugs, around a third of patients suffer from drug-resistant…
- Trial name
- FLUOFOCODYS (NCT07657975)
- Testing
- 5-ALA (Gliolan)
- Where
- 2 sites in France
- Volunteers
- 5 people
- Sponsor
- Hospices Civils de Lyon
Patients With Drug-resistant Focal Epilepsy, SEEG as Part of Presurgical Evaluation
Links Between Epileptic Activity, Sleep Disruption and Mental Content During Sleep
Interactions between epilepsy and sleep are numerous and bidirectional. Sleep can facilitate epileptic activity and seizures in several syndromes, while sleep deprivation increases cortical excitability and seizure…
- Trial name
- EPIDREAM 3 (NCT07605858)
- Testing
- Direct Electric Stimulation (DES)
- Where
- 2 sites in United States, France
- Volunteers
- 20 people
- Sponsor
- Hospices Civils de Lyon
Focal Epilepsy, Temporal Lobe Epilepsy
Spatial Scene Recognition Memory in Epilepsy Surgery
This study investigates the anatomical and physiological basis of spatial scene recognition memory in patients with temporal lobe epilepsy and temporal lobe lesions.
- Conditions
- Focal Epilepsy, Temporal Lobe Epilepsy, Medically Refractory Epilepsy, Memory Disorders
- Trial name
- NCT07580183
- Testing
- Virtual Tour Recognition Memory Task, Intracranial EEG Recording with Research Electrodes (Aim III only), MRI Neuroimaging and Neuropsychological Assessment (Aim I)
- Where
- 2 sites in United States
- Volunteers
- 620 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Focal Epilepsy
Long-term Safety and Tolerability of BHV-7000
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
- Trial name
- NCT06443463
- Testing
- BHV-7000
- Where
- 283 sites in United States, Argentina and 25 more
- Volunteers
- 660 people
- Sponsor
- Biohaven Therapeutics Ltd.
Drug-resistant Focal Epilepsies in Pediatric Population
Genetic and Electrophysiologic Study in Focal Drug-resistant Epilepsies
Brain somatic mutations are increasingly recognized as a major cause of focal epilepsies. These include mTOR pathway mutations underlying cortical malformations such as focal cortical dysplasia and hemimegalencephaly, and SLC35A2…
- Trial name
- GENEPHY (NCT02890641)
- Testing
- Sampling of blood, frozen resected tissues, and cerebrospinal fluid (CSF)
- Where
- France
- Volunteers
- 450 people
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
Drug Resistant Epilepsy, Epilepsy
A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
This will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with…
- Conditions
- Drug Resistant Epilepsy, Epilepsy, Epilepsy, Temporal Lobe, Seizures, Focal
- Trial name
- NCT06492720
- Testing
- Focused ultrasound (FUS) treatment
- Where
- Taiwan
- Volunteers
- 16 people
- Sponsor
- NaviFUS Corporation
Refractory Epilepsy, Focal Seizure
Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy
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…
- Conditions
- Refractory Epilepsy, Focal Seizure, Seizures, Focal, Seizures
- Trial name
- NCT04770337
- Testing
- STARSTIM device
- Where
- 32 sites in United States, Belgium and 2 more
- Volunteers
- 127 people
- Sponsor
- Neuroelectrics Corporation
Epilepsies, Focal, Pediatrics
Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain
Focal epilepsy is associated with widespread alterations in structural brain connectivity, often present at the disease onset and related to learning disabilities.
- Conditions
- Epilepsies, Focal, Pediatrics, Drug Resistant Epilepsy
- Trial name
- EPITRACT (NCT03268824)
- Testing
- Electroencephalogram (EEG), Diffusion Tensor imaging, Language assessment
- Where
- France
- Volunteers
- 82 people
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
Drug Resistant Epilepsy, Focal Seizure
Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of iQ-007
This is a randomized, double-blind, placebo-controlled study conducted in healthy adult volunteers to assess the safety, tolerability and pharmacokinetics of iQ-007.
- Trial name
- NCT06899230
- Testing
- iQ-007
- Where
- Australia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- iQure Australia Pty Ltd
Epilepsy Intractable, Focal Epilepsy
National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug
The main goal of this study is to evaluate the additional value of EEG-fMRI method in the presurgical evaluation of focal intractable epilepsy.
- Trial name
- ENERGY (NCT03278210)
- Where
- France
- Volunteers
- 102 people
- Sponsor
- University Hospital, Lille