EpilepsyGALVANI PS-1NCT04782869
Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy
A study testing transcranial direct current stimulation in people with Epilepsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2021to 21 Feb 2024
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - 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
Show all 10Show fewer
- 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
Who cannot join
- - 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
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Epileptologie et de Rythmologie Cérébrale
Marseille, 13005
About this study
Official title: Personalized Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: Evaluation of Therapeutic and Neurophysiological Effects
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
- Being tested
- transcranial direct current stimulation
- Keywords
- pharmaco-resistant epilepsy, transcranial stimulation, SEEG
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency
Percentage of change of seizures frequency
Measured: Comparison between baseline and month 2
Seizure frequency
Percentage of change of seizures frequency
Measured: Comparison between baseline and month 4
Seizure frequency
Percentage of change of seizures frequency
Measured: Comparison between baseline and month 6
Seizure frequency
Percentage of change of seizures frequency
Measured: Comparison between baseline and month 8
Secondary outcomes (4)
Depression
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) - score to 6 to 24, higher values mean worse outcome
Measured: Comparison between baseline and month 8
Anxiety disorders
Generalized Anxiety Disorder-7 (GAD-7) - score between 0 to 21, higher values mean worse outcome
Measured: Comparison between baseline and month 8
Seizures evaluation
National Hospital Seizure Severity Scale (NHS3) - score 1 to 31, higher values mean worse outcome
Measured: Comparison between baseline and month 8
Brain functional connectivity
National Hospital Seizure Severity Scale (NHS3) score 1 to 31, higher values mean worse outcome
Measured: Comparison between day 1 and day 5 of each session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start15 Mar 2021
- Primary completion20 Feb 2023
- Study completion21 Feb 2024
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier Arnaud, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782869
- Sponsor's protocol ID
- 2020-55
- Other IDs
- ID-RCB
- Acronym
- GALVANI PS-1
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2021
- 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
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
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
- Personalized Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: Evaluation of Therapeutic and Neurophysiological Effects
- ClinicalTrials.gov ID
- NCT04782869
- Acronym / sponsor ID
- GALVANI PS-1 / 2020-55
- Conditions
- Epilepsy
- Keywords
- pharmaco-resistant epilepsy, transcranial stimulation, SEEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 4 Mar 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tDCS (transcranial direct current stimulation) | Experimental | Device: transcranial direct current stimulationPatient will be treated for 3 cycles. A cycle is composed of 5 bi-sessions (one per day) of 20 minutes each. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- - 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
Key exclusion criteria (9 listed)
- - 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.
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 direct current stimulationPatients 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. | Device | tDCS (transcranial direct current stimulation) |
Primary outcome
Seizure frequency
Time frame: Comparison between baseline and month 2
Percentage of change of seizures frequency
Seizure frequency
Time frame: Comparison between baseline and month 4
Percentage of change of seizures frequency
Seizure frequency
Time frame: Comparison between baseline and month 6
Percentage of change of seizures frequency
Seizure frequency
Time frame: Comparison between baseline and month 8
Percentage of change of seizures frequency
4 secondary outcomes
Depression
Time frame: Comparison between baseline and month 8
Anxiety disorders
Time frame: Comparison between baseline and month 8
Seizures evaluation
Time frame: Comparison between baseline and month 8
Brain functional connectivity
Time frame: Comparison between day 1 and day 5 of each session
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 40347434Bartolomei 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.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
Enrolling by invitation
Neural Mechanisms for Stopping Ongoing Speech Production (Study 2)
Epilepsy, Speech
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
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.
Jean-Olivier Arnaud 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 direct current 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 10 inclusion and 9 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?
Seizure frequency (time frame: Comparison between baseline and month 2). 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 NCT04782869, 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.