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Completed

NCT Number: NCT04782869

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

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Epileptologie et de Rythmologie Cérébrale

Marseille, 13005, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • - 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).

Treatment and study plan

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.

Primary outcomes

  1. Seizure frequency

    Time frame: Comparison between baseline and month 2

    Percentage of change of seizures frequency

  2. Seizure frequency

    Time frame: Comparison between baseline and month 4

    Percentage of change of seizures frequency

  3. Seizure frequency

    Time frame: Comparison between baseline and month 6

    Percentage of change of seizures frequency

  4. Seizure frequency

    Time frame: Comparison between baseline and month 8

    Percentage of change of seizures frequency

Secondary outcomes

  1. Depression

    Time frame: Comparison between baseline and month 8

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

  2. Anxiety disorders

    Time frame: Comparison between baseline and month 8

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

  3. Seizures evaluation

    Time frame: Comparison between baseline and month 8

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

  4. Brain functional connectivity

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

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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Personalized Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: Evaluation of Therapeutic and Neurophysiological Effects

Acronym: GALVANI PS-1

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Mar 4, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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