Model-based Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: a Cross-over Study of Efficacy

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 9
Healthy Volunteers: f
View:

• Patient, parents or legal representative who have given written informed consent;

• Age: ≥ 9 years;

• Patients with drug-resistant focal epilepsy with no surgical indication or with a previous surgical failure, refusing surgery or with a planned surgery compatible with the total duration of this study;

• 4\) 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 ;

• Patient having a pre-SEEG 3D-T1 MRI and CT-scan with electrodes during SEEG available;

• A research MRI scan that is suitable for navigated brain stimulation (NBS) and generation of electrical fields including dMRI for tractography;

• Number of seizures ≥3/month during the baseline (before the first session of tDCS treatment);

• Patient having stable medications for epilepsy 4 weeks before the baseline (except rescue treatment);

• Patient's IQ, which in the investigator's opinion will enable questionnaires and neuropsychological assessments to be carried out;

⁃ Patient able to understand, speak and write in French;

⁃ Patient able to follow study's procedure;

⁃ Patient beneficiary or affiliated to a health insurance plan.

Locations
Other Locations
France
Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques
RECRUITING
Bordeaux
Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon
RECRUITING
Bron
Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille
NOT_YET_RECRUITING
Lille
Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone
RECRUITING
Marseille
Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne
NOT_YET_RECRUITING
Paris
Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou
NOT_YET_RECRUITING
Rennes
Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Fabrice Bartolomei, MD, PhD
fabrice.bartolomei@ap-hpm.fr
0491384990
Backup
Sophie Tardoski
sophie.tardoski@ap-hm.fr
0491381594
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2027-11-18
Participants
Target number of participants: 60
Treatments
Other: tDCS - Sham
Patient will be randomized to firstly receive tDCS (10 non consecutive days, 20 minutes twice a day with 20 minutes of break) and then Sham (10 non consecutive days, 20 minutes twice a day with 20 minutes of break).
Other: Sham - tDCS
Patient will be randomized to firstly receive Sham (10 non consecutive days, 20 minutes twice a day with 20 minutes of break) and then tDCS (10 non consecutive days, 20 minutes twice a day with 20 minutes of break).
Sponsors
Leads: Assistance Publique Hopitaux De Marseille
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France - LTSI, CRMBM-CEMEREM, Neuroelectrics Corporation

This content was sourced from clinicaltrials.gov