Status:
COMPLETED
Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Epilepsy
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
This project aims to conduct a pilot study based on the targeting of the epileptogenic zone previously localized very precisely by stereoelectroencephalography (SEEG). SEEG is used as part of the pre-...
Eligibility Criteria
Inclusion
- \- Age: Older than 12 years old
- Patients with drug-resistant focal epilepsy with no surgical indication or with a previous surgical failure or refusing surgery.
- SEEG previously performed before inclusion with an adequate definition of the epileptogenic zone
- A clinical or research MRI scan that is suitable for navigated brain stimulation (NBS) and definition of target area.
- Number of seizures \>3/month during the baseline (before the first session of tDCS treatment), for at least 3 months
- Have stable medications for the whole study duration and few weeks before
- Total IQ\>65
- Be able to understand, speak and write in French
- Patient, parents or legally representative who have given written informed consent to allow the study data collection procedures,
- Be a beneficiary of affiliated to a health insurance plan
Exclusion
- \- Generalized epilepsy
- Presenting contraindication to MRI, a serious intercurrent pathology, a progressive brain tumor
- Skin conditions (e.g., eczema, lesion)
- Any cranial metal implants (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).
- 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.
- Metal inside the head (outside the mouth) such as shrapnel, surgical clips
- Patient currently participating in another clinical trial or having participated in a clinical trial in the month prior to inclusion.
- Any condition that makes the study subject, in the opinion of the investigator, unsuitable for the study.
- Person protected by articles L1121-5, L1121-6 and L1121-8 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).
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04782869
Start Date
March 15 2021
End Date
February 21 2024
Last Update
February 26 2024
Active Locations (1)
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1
Service d'Epileptologie et de Rythmologie Cérébrale
Marseille, France, 13005