Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic
NCT ID: NCT06334952
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-12-18
2028-01-18
Brief Summary
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* 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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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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).
transcranial direct current stimulation
Research MRI includes 3D-T1 weighted MRI (3D-T1), diffusion MRI (dMRI), resting-state functional MRI (rsfMRI).
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).
transcranial direct current stimulation
Research MRI includes 3D-T1 weighted MRI (3D-T1), diffusion MRI (dMRI), resting-state functional MRI (rsfMRI).
Interventions
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transcranial direct current stimulation
Research MRI includes 3D-T1 weighted MRI (3D-T1), diffusion MRI (dMRI), resting-state functional MRI (rsfMRI).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 generation of electrical fields including dMRI for tractography;
8. Number of seizures ≥3/month during the baseline (before the first session of tDCS treatment);
9. Patient having stable medications for epilepsy 4 weeks before the baseline (except rescue treatment);
10. Patient's IQ, which in the investigator's opinion will enable questionnaires and neuropsychological assessments to be carried out;
11. Patient able to understand, speak and write in French;
12. Patient able to follow study's procedure;
13. Patient beneficiary or affiliated to a health insurance plan.
Exclusion Criteria
2. 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;
3. Patients with psychogenic nonepileptic seizures;
4. 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) ;
5. Substance use abuse that may include alcohol , opioids (heroin, fentanyl) stimulants (Cocaine, methamphetamine) , hallucinogens (LSD, psilocybin (magic mushrooms), MDMA (Ecstasy))
6. Patient presenting a serious intercurrent pathology and/or a progressive brain tumor
7. Patient having damaged skin or scalp that may interfere with tDCS stimulation (e.g., eczema, lesion);
8. Patient having any cranial metal implants such as shrapnel or surgical clips (excluding \<1 mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant)
9. Patient having previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm;
10. Any condition that makes the study subject, in the opinion of the investigator, unsuitable for the study including presence of any disease, abnormality, medical or physical condition that, in the opinion of the investigator, may adversely impact, compromise, interfere, limit, affect or reduce the safety of the subject, the integrity of the data ;
11. Person protected by articles L1121-5, L1121-6 of Public Health Code (pregnant or breastfeeding woman, deprived of liberty by judicial decision, situations of social fragility, adults unable or unable to express their consent, person under judicial safeguard (article L1122-2)).
9 Years
ALL
No
Sponsors
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CRMBM-CEMEREM
UNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France - LTSI
UNKNOWN
Neuroelectrics Corporation
INDUSTRY
Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Locations
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Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques
Bordeaux, , France
Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon
Bron, , France
Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille
Lille, , France
Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone
Marseille, , France
Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne
Paris, , France
Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou
Rennes, , France
Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Jerome Aupy
Role: primary
Sylvain Rheims
Role: primary
Philippe Derambure
Role: primary
Fabrice Bartolomei
Role: primary
Martine Gavaret
Role: primary
Anca Nica
Role: primary
Luc Valton
Role: primary
Other Identifiers
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RCAPHM23_0074
Identifier Type: -
Identifier Source: org_study_id
ID-RCB
Identifier Type: OTHER
Identifier Source: secondary_id