Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic
Condition(s) studied
Investigational drug(s) / intervention(s)
transcranial direct current stimulation: Research MRI includes 3D-T1 weighted MRI (3D-T1), diffusion MRI (dMRI), resting-state functional MRI (rsfMRI).
Study 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
Primary outcome measure(s)
- To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. — Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study. - To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. — V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study. - To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. — V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study. - To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. — V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques | Bordeaux | France | Recruiting |
| Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon | Bron | France | Recruiting |
| Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille | Lille | France | Not Yet Recruiting |
| Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone | Marseille | France | Recruiting |
| Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne | Paris | France | Not Yet Recruiting |
| Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou | Rennes | France | Not Yet Recruiting |
| Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet | Toulouse | France | Not Yet Recruiting |
More Assistance Publique Hopitaux De Marseille trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06334952 on ClinicalTrials.gov ↗ ← All trials in France