NCT06334952 Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic
| NCT ID | NCT06334952 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-12-18 |
| Primary Completion | 2026-12-18 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: 1. Patient, parents or legal representative who have given written informed consent; 2. Age: ≥ 9 years; 3. 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; 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 ; 5. Patient having a pre-SEEG 3D-T1 MRI and CT-scan with electrodes during SEEG available; This MRI can be done specifically for this trial or might be reused from EPINOV or NEURO7T trial) 6. For patients with VNS, experiencing no response or partial response, and for whom the stimulation parameters have been stable for at least 6 months 7. A research MRI scan that is suitable for navigated brain stimulation (NBS) and g
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