Personalized brain stimulation for treating drug-resistant epilepsy in children
Optimized and Personalized Trans-cranial Brain Stimulation in Partial Refractory Epilepsies
This study is testing a personalized brain stimulation treatment for children with hard-to-treat epilepsy to see if it can help control their seizures better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT06212609 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of optimized transcranial electrical stimulation therapy for children aged 1 to 18 with refractory partial epilepsy. The approach aims to personalize treatment by targeting specific brain areas associated with seizure activity, utilizing advanced diagnostic techniques such as high-resolution EEG and MRI. The study focuses on patients who have not responded adequately to conventional antiepileptic medications and are considered potential candidates for surgical intervention. By optimizing stimulation parameters, the trial seeks to improve seizure control and overall quality of life for participants.
Who should consider this trial
Good fit: Ideal candidates include children aged 1 to 18 with refractory partial epilepsy who experience at least 4 seizures per month and have not responded to two or more antiepileptic drugs.
Not a fit: Patients with generalized epilepsy or those not meeting the age criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce seizure frequency and improve the quality of life for children with drug-resistant epilepsy.
How similar studies have performed: While the use of transcranial electrical stimulation is a novel approach in this context, similar studies have shown promise in other neurological conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any patient, male or female aged 1 to 18, with refractory partial epilepsy considered potentially surgical according to the definition of ILAE. Drug-resistant epilepsy can be defined as the failure of adequate therapeutic trials of two antiepileptics (either monotherapy or in combination) so that the patient is free from seizures on a lasting basis. * Any epileptic patient with interictal epileptic spikes on his standard or High Resolution EEG and or on the Magnetoencephalography examination * Any epileptic patient undergoing a structural MRI * Any patient who has agreed to participate in the PerEpi 1 study allowing the optimization of the location of epileptic sources and the modelling of the optimization of the parameters of transcranial electrical stimulation * Patients who have at least 4 seizures per month Exclusion Criteria: * Patient not meeting the age criteria * And/or presenting generalized epilepsy * And/or presenting diffuse interictal peaks and/or presenting a serious alteration of the general condition and vital functions * And/or in the event of refusal by one of the parents or the child * Pregnant, parturient or breastfeeding woman. * Contraindication to the use of mc-tDCS stimulation without seizure
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Fabrice Wallois, Pr
- Email: fabrice.wallois@u-picardie.fr
- Phone: 03 22 087775
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.