Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy

NCT04782869 | Completed

• 2 other identifiers: 2020-55ID-RCB
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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-surgical assessment. It consists, thanks to the intracerebral implantation of electrodes in the brain of patients, to perform an intracerebral electrophysiological recording and thus to precisely explore the epileptogenic regions. In order to study the neuromodulatory and therapeutic effects of tDCS on epileptic brains, non-invasive techniques for measuring electrophysiological brain activity such as magnetoencephalography (MEG) and high-resolution electroencephalography (HR EEG) will be used. Finally, since epilepsy is considered to be a disorder of brain functional networks associated with disturbed brain connectivity, the effects of tDCS on cortical excitability by studying the variations in functional connectivity induced by stimulation will be studied.

Conditions

Epilepsy

Keywords

pharmaco-resistant epilepsy; transcranial stimulation; SEEG

Outcome Measures

Primary Outcomes (4)

• Seizure frequency

  Percentage of change of seizures frequency

  Comparison between baseline and month 2

• Seizure frequency

  Percentage of change of seizures frequency

  Comparison between baseline and month 4

• Seizure frequency

  Percentage of change of seizures frequency

  Comparison between baseline and month 6

• Seizure frequency

  Percentage of change of seizures frequency

  Comparison between baseline and month 8

Secondary Outcomes (4)

• Depression

  Comparison between baseline and month 8

• Anxiety disorders

  Comparison between baseline and month 8

• Seizures evaluation

  Comparison between baseline and month 8

• Brain functional connectivity

  Comparison between day 1 and day 5 of each session

Study Arms (1)

tDCS (transcranial direct current stimulation)

EXPERIMENTAL

Patient will be treated for 3 cycles. A cycle is composed of 5 bi-sessions (one per day) of 20 minutes each.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

Patients will be treated using Starstim 8 device, a device allowing to perform transcranial direct current stimulation. The position of electrodes will be personalized based on the localization of the epileptogenic zone.

tDCS (transcranial direct current stimulation)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• 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

You may not qualify if:

• \- 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
• 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).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Service d'Epileptologie et de Rythmologie Cérébrale

Marseille, 13005, France

Location

Related Publications (1)

• Bartolomei F, Daoud M, Delourme M, Tardoski S, Makhalova J, Bourguiba E, Medina Villalon S, Lagarde S, Wendling F, Ruffini G, Salvador R, Pizzo F, Giusiano B. Personalized multichannel transcranial direct current electrical stimulation (tDCS) in drug-resistant epilepsy: A SEEG based open-labeled study. Epilepsia Open. 2025 Aug;10(4):1034-1042. doi: 10.1002/epi4.70055. Epub 2025 May 10.

  PMID: 40347434 RESULT

MeSH Terms

Conditions

Epilepsy

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Jean-Olivier Arnaud

  AP-HM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 4, 2021
• Study Start: March 15, 2021
• Primary Completion: February 20, 2023
• Study Completion: February 21, 2024
• Last Updated: May 8, 2026

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)