EpilepsyGALVANI PS-2NCT05250713
Evaluation of Direct Effects of Electric Fields on Brain
A study testing Transcranial stimulation in people with Epilepsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Transcranial stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2022to 22 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of the Immediate Impact of Weak Electric Fields on Brain Activity by SEEG Measurements in Drug-resistant Focal Epilepsy Patients
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).
- Conditions
- Epilepsy
- Being tested
- Transcranial stimulation
- Keywords
- tDCS (transcranial direct current stimulation), tACS (transcranial alternate current stimulation), Starstim, transcranial stimulation, SEEG (stereoelectroencephalography)
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial stimulationDevice
Patients will receive either direct current stimulation or alternate stimulation.
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Experimental | Patients receiving tDCS during SEEG investigation Receives: Device: Transcranial stimulation |
| tACS | Experimental | Patients receiving tACS during SEEG intervention Receives: Device: Transcranial stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of epileptogenic markers in intracranial brain signals recordings
Rate and amplitude of interictal epileptogenic spikes
Measured: During tDCS or tACS
Measure of epileptogenic markers in intracranial brain signals recordings
Rate and amplitude of interictal epileptogenic spikes
Measured: After tDCS or tACS
Measure of functional connectivity in intracranial brain signals recordings
Neural network excitability
Measured: During tDCS or tACS
Measure of functional connectivity in intracranial brain signals recordings
Neural network excitability
Measured: After tDCS or tACS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start26 Apr 2022
- Primary completion8 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250713
- Sponsor's protocol ID
- 2020-66
- Other IDs
- ID-RCB
- Acronym
- GALVANI PS-2
- Status last verified
- Aug 2024
- First submitted
- 30 Jan 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simula S, Makhalova J, Pizzo F, Garnier E, Damiani G, Mercadal B, Chiara Biagi M, Salvador R, Medina-Villalon S, Ruffini G, Wendling F, George Benar C, Bartolomei F. Impact of transcranial electrical stimulation on simultaneous stereoelectroencephalography recordings: A randomized sham-controlled study. Clin Neurophysiol. 2024 Oct;166:211-222. doi: 10.1016/j.clinph.2024.08.003. Epub 2024 Aug 14.
PubMed 39182340
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of the Immediate Impact of Weak Electric Fields on Brain Activity by SEEG Measurements in Drug-resistant Focal Epilepsy Patients
- ClinicalTrials.gov ID
- NCT05250713
- Acronym / sponsor ID
- GALVANI PS-2 / 2020-66
- Conditions
- Epilepsy
- Keywords
- tDCS (transcranial direct current stimulation), tACS (transcranial alternate current stimulation), Starstim, transcranial stimulation, SEEG (stereoelectroencephalography)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 8 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS | Experimental | Device: Transcranial stimulationPatients receiving tDCS during SEEG investigation |
| tACS | Experimental | Device: Transcranial stimulationPatients receiving tACS during SEEG intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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:
- Any condition that, according to the investigator, is not compatible with carrying out the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial stimulationPatients will receive either direct current stimulation or alternate stimulation. | Device | tACS, tDCS |
Primary outcome
Measure of epileptogenic markers in intracranial brain signals recordings
Time frame: During tDCS or tACS
Rate and amplitude of interictal epileptogenic spikes
Measure of epileptogenic markers in intracranial brain signals recordings
Time frame: After tDCS or tACS
Rate and amplitude of interictal epileptogenic spikes
Measure of functional connectivity in intracranial brain signals recordings
Time frame: During tDCS or tACS
Neural network excitability
Measure of functional connectivity in intracranial brain signals recordings
Time frame: After tDCS or tACS
Neural network excitability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 39182340Simula S, Makhalova J, Pizzo F, Garnier E, Damiani G, Mercadal B, Chiara Biagi M, Salvador R, Medina-Villalon S, Ruffini G, Wendling F, George Benar C, Bartolomei F. Impact of transcranial electrical stimulation on simultaneous stereoelectroencephalography recordings: A randomized sham-controlled study. Clin Neurophysiol. 2024 Oct;166:211-222. doi: 10.1016/j.clinph.2024.08.003. Epub 2024 Aug 14.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François CREMIEUX study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial stimulation in people with Epilepsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of epileptogenic markers in intracranial brain signals recordings (time frame: During tDCS or tACS). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05250713, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.