About this trial
The goal of this clinical trial is to to obtain a significant decrease in seizure frequency in patients with refractory focal epilepsy after applying treatment of cathodal tDCS, compared to sham stimulation drug-resistant epileptic patient. The main questions it aims to answer are:
* Changes in quality of life * Percent of newly reported side effects after the stimulation period * Scores in epilepsy severity. Participants will be randomized in a cross-over, and will receive 10 days of tDCS or Sham. Each day will allow 2 periods of 20 minutes stimulation separated by 20 minutes off (with 40 minutes of cathodal stimulation total).
Eligibility criteria
Qualifiers
Patient, parents or legal representative who have given written informed consent;
Age: ≥ 9 years;
Patients with drug-resistant focal epilepsy with no evolutive brain lesion and no surgical indication or with a previous surgical failure, refusing surgery or with a planned surgery compatible with the total duration of this study;
SEEG previously performed before inclusion with an adequate definition of the epileptogenic zone with all data required (pre-SEEG MRI, CT-scan or MRI with electrodes during SEEG and SEEG files) for personalization ;
Disqualifiers
Patients with seizures of generalized onset in the last 12 months;
Patient with multifocal epileptogenic zones, bilateral epileptogenic zone, or poorly defined epileptogenic zone. The epileptogenic network should not be restricted to the orbito frontal cortex or cingulate cortex;
Patients with psychogenic nonepileptic seizures;
Patient presenting a contraindication to MRI 3T (patient having a pacemaker, metallic foreign bodies, non-removably implanted electronic medical devices, claustrophobia, inability to remain in supine position, vagus nerve stimulator even when switched off is a contraindication for MRI 3T. EPINOV or NEURO 7T trial patients, who have accepted for their data to be reused, can be included even while wearing a VNS device) ;
Trial design
Treatments tested in this trial
- transcranial direct current stimulation
Treatment groups
Sponsors and collaborators
Assistance Publique Hopitaux De Marseille
Lead sponsor
CRMBM-CEMEREM
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Neuroelectrics Corporation
Collaborator