Actively Recruiting
Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic
Led by Assistance Publique Hopitaux De Marseille · Updated on 2025-12-19
60
Participants Needed
7
Research Sites
160 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique Hopitaux De Marseille
Lead Sponsor
C
CRMBM-CEMEREM
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient, parents or legal representative who have given written informed consent
- Age 9 years or older
- Patients with drug-resistant focal epilepsy without evolving brain lesion and no surgical indication or with previous surgical failure, refusing surgery or with planned surgery compatible with study duration
- SEEG previously performed with adequate definition of epileptogenic zone and required data for personalization
- Availability of pre-SEEG 3D-T1 MRI and CT-scan with electrodes during SEEG
- For patients with VNS, stable stimulation parameters for at least 6 months and no or partial response
- Research MRI suitable for navigated brain stimulation including diffusion MRI for tractography
- At least 3 seizures per month during baseline before first tDCS session
- Stable epilepsy medications for 4 weeks before baseline (except rescue treatment)
- Patient's IQ sufficient for questionnaires and neuropsychological assessments
- Ability to understand, speak, and write French
- Ability to follow study procedures
- Beneficiary or affiliated to a health insurance plan
You will not qualify if you...
- Seizures of generalized onset in the last 12 months
- Multifocal, bilateral, or poorly defined epileptogenic zones; epileptogenic network restricted to orbito frontal or cingulate cortex
- Psychogenic nonepileptic seizures
- Contraindication to 3T MRI (including pacemaker, metallic foreign bodies, implanted electronic devices, claustrophobia, inability to lie supine, vagus nerve stimulator except specific trial data reuse cases)
- Substance abuse including alcohol, opioids, stimulants, hallucinogens
- Serious intercurrent pathology or progressive brain tumor
- Damaged skin or scalp interfering with tDCS (e.g., eczema, lesion)
- Cranial metal implants or medical devices incompatible with study
- Previous skull surgeries leaving defects allowing cylinder insertion ≥5 mm radius
- Any condition deemed unsuitable by investigator that may impact safety or data integrity
- Persons protected by law such as pregnant or breastfeeding women, those deprived of liberty, socially fragile individuals, adults unable to consent, or under judicial safeguard
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques
Bordeaux, France, 33000
Actively Recruiting
2
Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon
Bron, France, 69677
Actively Recruiting
3
Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille
Lille, France, 59037
Not Yet Recruiting
4
Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone
Marseille, France, 13005
Actively Recruiting
5
Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne
Paris, France, 75014
Not Yet Recruiting
6
Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou
Rennes, France, 35033
Not Yet Recruiting
7
Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet
Toulouse, France, 31059
Not Yet Recruiting
Research Team
F
Fabrice Bartolomei, MD, PhD
CONTACT
S
Sophie Tardoski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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