Actively Recruiting
Model-based Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: A Cross-over Study of Efficacy
Led by Assistance Publique Hopitaux De Marseille · Updated on 2025-12-19
60
Participants Needed
7
Research Sites
56 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
Researchers are evaluating the use of personalized transcranial direct current stimulation (tDCS) to reduce seizure frequency in patients with drug-resistant focal epilepsy. This trial aims to compare the effects of active tDCS treatment to a sham (placebo) stimulation, focusing on changes in seizure frequency, quality of life, side effects, and epilepsy severity. The study uses a randomized, triple-blind, cross-over design to assess the impact of these treatments in patients who continue to experience seizures despite medication or surgery. Participants will receive two treatment cycles in random order: one with active tDCS and one with sham stimulation. Each cycle consists of 10 non-consecutive days, with two 20-minute stimulation periods per day separated by a 20-minute break, totaling 40 minutes of cathodal stimulation daily. The study includes detailed brain imaging for treatment personalization and allows for a washout period between treatments in this cross-over setup. During the study, participants will be monitored at multiple visits up to 8 weeks after each treatment cycle. Researchers will assess seizure frequency and severity, quality of life, psychiatric symptoms, and any side effects. The study includes frequent evaluations to measure changes compared to baseline, with a focus on safety and treatment response. Total participation spans from baseline through follow-up visits after both treatment cycles, ensuring comprehensive monitoring of outcomes.
CONDITIONS
Brief 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 must provide written informed consent
- Age 9 years or older
- Diagnosed with drug-resistant focal epilepsy without progressive brain lesions and no surgical indication, or with previous surgical failure or planned surgery compatible with study duration
- Stereoelectroencephalography (SEEG) performed with adequate definition of the epileptogenic zone and all required imaging data
- Pre-SEEG 3D-T1 MRI and CT scan with electrodes available
- If using vagus nerve stimulation (VNS), stimulation parameters must have been stable for at least 6 months with no or partial response
- Research MRI suitable for navigated brain stimulation including diffusion MRI for tractography
- Experiencing at least 3 seizures per month during baseline
- Stable epilepsy medications for at least 4 weeks before baseline, except rescue treatment
- Cognitive ability to complete questionnaires and neuropsychological assessments
- Able to understand, speak, and write French
- Able to follow study procedures
- Beneficiary or affiliated to a health insurance plan
You will not qualify if you...
- Seizures of generalized onset within the last 12 months
- Multifocal, bilateral, or poorly defined epileptogenic zones; epileptogenic network restricted to orbitofrontal or cingulate cortex
- Presence of psychogenic nonepileptic seizures
- Contraindications to 3T MRI such as pacemakers, metallic implants, non-removable electronic devices, claustrophobia, or inability to remain supine; vagus nerve stimulator is a contraindication except for certain trial data reuse cases
- Substance abuse including alcohol, opioids, stimulants, or hallucinogens
- Serious intercurrent illness or progressive brain tumor
- Damaged skin or scalp conditions interfering with tDCS
- Cranial metal implants or medical devices such as pacemakers, deep brain stimulators, infusion pumps, cochlear implants
- Previous skull surgeries leaving defects suitable for cylinder insertion
- Any condition judged by the investigator to compromise safety or data integrity
- Protected persons under public health law including pregnant or breastfeeding women, those deprived of liberty, socially fragile adults, or legally protected individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 non-consecutive days in total (two cycles of 10 days each)
Participants receive transcranial direct current stimulation (tDCS) or sham stimulation in two treatment cycles, each lasting 10 non-consecutive days with two 20-minute sessions per day separated by a 20-minute break.
Participants have stimulation sessions twice a day during each 10-day cycle
Duration - Up to 8 weeks following each 10-day stimulation cycle
Participants are monitored for seizure frequency, seizure severity, quality of life, psychiatric changes, and safety up to 8 weeks after each treatment cycle ends.
4 visits (in-person) at 4 and 8 weeks after each treatment cycle
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
S
Sophie Tardoski
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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