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Completed

NCT Number: NCT05250713

Evaluation of Direct Effects of Electric Fields on Brain

Transcranial current stimulation (tCS), a safe, tolerable technique employing weak currents (~ 1 mA) applied to the scalp, has been shown to be a promising technique in alleviating seizures in focal epilepsy patients. Although studies reveal a decrease in the epileptiform activity due to tCS, this field lacks a quantification of neurophysiological changes during and immediately after stimulation. The investigators hypothesise that tCS can effectively reduce the amplitude and rate of interictal spikes as well as the functional connectivity between regions during and immediately after stimulation. It is thus planned to deliver an extensive quantitative description of the tCS effects on interictal spike activity, functional connectivity and other tissue biomarkers, using the simultaneous recording of intracranial signals during tCS. Moreover, the investigators seek to compare these variations between different tCS paradigms (direct current -tDCS- vs alternate current -tACS- stimulation).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service Epileptologie et 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

  • Provision of signed and dated informed consent form
  • Male or female, aged ≥ 18 years old
  • Focal drug-resistant epilepsy
  • Patient undergoing a clinical SEEG investigation
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Patient affiliated or beneficiary of a health insurance plan
  • Patient for whom MRI images (3D T1) are exploitable and fit with the minimum MRI requirements needed for biophysical modelling (cf annex in 14.), prior to SEEG electrodes implantation
  • Patient for whom a CT-scan with electrodes (or MRI with electrodes) has been realized after SEEG procedure.

Exclusion criteria

  • Difficulty to read or understand the French language, or inability to understand the information regarding 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 or unable to express their consent). Pregnancy will be evaluated during screening with a urine pregnancy test.
  • Presence of severe negative outcome of SEEG surgery preventing the acquisition of SEEG data (i.e. hemorragic complications, subcutaneous infection), at the time of inclusion.
  • Patient showing contraindications for electric stimulation at the time of inclusion:

(A) Patient with unstable or non-controlled neuropsychiatric illness (B) Patients having cardiac or medication implants (C) Patients with implanted pacemakers (D) Patients with serious brain injury (E) Patients showing damage of skin at sites of stimulation

  • Any condition that, according to the investigator, is not compatible with carrying out the study

Treatment and study plan

Transcranial stimulation

Device

Patients will receive either direct current stimulation or alternate stimulation.

Primary outcomes

  1. Measure of epileptogenic markers in intracranial brain signals recordings

    Time frame: During tDCS or tACS

    Rate and amplitude of interictal epileptogenic spikes

  2. Measure of epileptogenic markers in intracranial brain signals recordings

    Time frame: After tDCS or tACS

    Rate and amplitude of interictal epileptogenic spikes

  3. Measure of functional connectivity in intracranial brain signals recordings

    Time frame: During tDCS or tACS

    Neural network excitability

  4. Measure of functional connectivity in intracranial brain signals recordings

    Time frame: After tDCS or tACS

    Neural network excitability

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Quantification of the Immediate Impact of Weak Electric Fields on Brain Activity by SEEG Measurements in Drug-resistant Focal Epilepsy Patients

Acronym: GALVANI PS-2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 22, 2022
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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