Actively Recruiting
Optimized and Personalized Transcranial Brain Stimulation for Drug-Resistant Partial Epilepsies in Children and Adolescents
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2024-01-31
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Epilepsy is a common neurological disorder affecting 0.5% to 1% of the population, often diagnosed in children and impacting quality of life. Around one-third of patients with focal epilepsy do not respond well to drug therapy, and while surgery can help, only a small percentage qualify due to localization challenges or risks of neurological damage. This study focuses on exploring new diagnostic and treatment approaches for drug-resistant partial epilepsy in children and adolescents. The trial evaluates a new non-invasive, personalized transcranial electrical stimulation therapy designed to manage pharmaco-resistant focal epilepsies. Participants aged 1 to 18 will receive optimized brain stimulation based on individual epileptic source mapping, aiming to reduce seizure frequency. This treatment is delivered without surgery and seeks to improve the precision and effectiveness of brain stimulation in this population. Participants will be monitored over 10 weeks to measure changes in their seizure numbers compared to baseline. The study includes EEG and magnetoencephalography examinations, structural MRI scans, and tracking of seizure frequency. Researchers will assess how well the transcranial electrical stimulation controls seizures and monitor safety and tolerability during the study period.
CONDITIONS
Brief Title
Optimized and Personalized Trans-cranial Brain Stimulation in Partial Refractory Epilepsies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 1 to 18 years with refractory partial epilepsy considered potentially surgical
- Patients with drug-resistant epilepsy, defined by failure of two adequate antiepileptic treatments
- Patients showing interictal epileptic spikes on standard or high-resolution EEG or magnetoencephalography
- Patients undergoing structural MRI examination
- Patients who have agreed to participate in the PerEpi 1 study for optimizing epileptic source location
- Patients experiencing at least 4 seizures per month
You will not qualify if you...
- Patients outside the age range of 1 to 18 years
- Patients with generalized epilepsy
- Patients with diffuse interictal peaks or serious alteration of general condition and vital functions
- Patients or guardians refusing participation
- Pregnant, parturient, or breastfeeding females
- Patients with contraindications to mc-tDCS stimulation without seizures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 10 weeks
Participants receive non-invasive, individualized, and optimized transcranial electrical stimulation therapy for managing drug-resistant partial epilepsies.
Trial Site Locations
Total: 1 location
1
CHU Amiens
Amiens, France, 80054
Actively Recruiting
Research Team
F
Fabrice Wallois, Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
0
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