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CompletedNCT04782869GALVANI PS-1Updated May 8, 2026

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

An interventional study of transcranial direct current stimulation in Epilepsy, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Epilepsy

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Keywords

  • pharmaco-resistant epilepsy
  • transcranial stimulation
  • SEEG
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 17 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • - 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 criteria

Exclusion Criteria:

  • - 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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    tDCS (transcranial direct current stimulation)

    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

  • Devicetranscranial direct current stimulation

    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.

06

What researchers measure

Primary outcomes

  1. Seizure frequency

    Percentage of change of seizures frequency

    Time frame: Comparison between baseline and month 2

  2. Seizure frequency

    Percentage of change of seizures frequency

    Time frame: Comparison between baseline and month 4

  3. Seizure frequency

    Percentage of change of seizures frequency

    Time frame: Comparison between baseline and month 6

  4. Seizure frequency

    Percentage of change of seizures frequency

    Time frame: Comparison between baseline and month 8

Secondary outcomes

  1. Depression

    Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) - score to 6 to 24, higher values mean worse outcome

    Time frame: Comparison between baseline and month 8

  2. Anxiety disorders

    Generalized Anxiety Disorder-7 (GAD-7) - score between 0 to 21, higher values mean worse outcome

    Time frame: Comparison between baseline and month 8

  3. Seizures evaluation

    National Hospital Seizure Severity Scale (NHS3) - score 1 to 31, higher values mean worse outcome

    Time frame: Comparison between baseline and month 8

  4. Brain functional connectivity

    National Hospital Seizure Severity Scale (NHS3) score 1 to 31, higher values mean worse outcome

    Time frame: Comparison between day 1 and day 5 of each session

07

Study locations

1 site
  • Service d'Epileptologie et de Rythmologie Cérébrale
    Marseille, 13005, France
08

References and documents

Publications

  • 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. PubMed 40347434 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04782869
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Mar 4, 2021
Start date
Mar 15, 2021
Primary completion
Feb 20, 2023
Completion
Feb 21, 2024
Last update
May 8, 2026

Study contacts

Jean-Olivier Arnaud
study director · AP-HM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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