EpilepsyGALVANI GS-3NCT06334952
Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic
A study testing transcranial direct current stimulation in people with Epilepsy and Drug Resistant Epilepsy, run by Assistance Publique Hopitaux De Marseille at 7 sites in France.
Trial summary
The goal of this clinical trial is to to obtain a significant decrease in seizure frequency in patients with refractory focal epilepsy after applying treatment of cathodal tDCS, compared to sham stimulation drug-resistant epileptic patient. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Epilepsy, Drug Resistant 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
- 60 participants
- Where
- 7 sitesFrance
- Study dates
- 18 Dec 2024to 18 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient, parents or legal representative who have given written informed consent;
- Age: ≥ 9 years;
- Patients with drug-resistant focal epilepsy with no evolutive brain lesion and no surgical indication or with a previous surgical failure, refusing surgery or with a planned surgery compatible with the total duration of this study;
- SEEG previously performed before inclusion with an adequate definition of the epileptogenic zone with all data required (pre-SEEG MRI, CT-scan or MRI with electrodes during SEEG and SEEG files) for personalization ;
- Patient having a pre-SEEG 3D-T1 MRI and CT-scan with electrodes during SEEG available; This MRI can be done specifically for this trial or might be reused from EPINOV or NEURO7T trial)
- For patients with VNS, experiencing no response or partial response, and for whom the stimulation parameters have been stable for at least 6 months
Show all 13Show fewer
- A research MRI scan that is suitable for navigated brain stimulation (NBS) and generation of electrical fields including dMRI for tractography;
- Number of seizures ≥3/month during the baseline (before the first session of tDCS treatment);
- Patient having stable medications for epilepsy 4 weeks before the baseline (except rescue treatment);
- Patient's IQ, which in the investigator's opinion will enable questionnaires and neuropsychological assessments to be carried out;
- Patient able to understand, speak and write in French;
- Patient able to follow study's procedure;
- Patient beneficiary or affiliated to a health insurance plan.
Who cannot join
- Patients with seizures of generalized onset in the last 12 months;
- Patient with multifocal epileptogenic zones, bilateral epileptogenic zone, or poorly defined epileptogenic zone. The epileptogenic network should not be restricted to the orbito frontal cortex or cingulate cortex;
- Patients with psychogenic nonepileptic seizures;
- Patient presenting a contraindication to MRI 3T (patient having a pacemaker, metallic foreign bodies, non-removably implanted electronic medical devices, claustrophobia, inability to remain in supine position, vagus nerve stimulator even when switched off is a contraindication for MRI 3T. EPINOV or NEURO 7T trial patients, who have accepted for their data to be reused, can be included even while wearing a VNS device) ;
- Substance use abuse that may include alcohol , opioids (heroin, fentanyl) stimulants (Cocaine, methamphetamine) , hallucinogens (LSD, psilocybin (magic mushrooms), MDMA (Ecstasy))
- Patient presenting a serious intercurrent pathology and/or a progressive brain tumor
Show all 11Show fewer
- Patient having damaged skin or scalp that may interfere with tDCS stimulation (e.g., eczema, lesion);
- Patient having any cranial metal implants such as shrapnel or surgical clips (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)
- Patient having 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;
- Any condition that makes the study subject, in the opinion of the investigator, unsuitable for the study including presence of any disease, abnormality, medical or physical condition that, in the opinion of the investigator, may adversely impact, compromise, interfere, limit, affect or reduce the safety of the subject, the integrity of the data ;
- Person protected by articles L1121-5, L1121-6 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, person under judicial safeguard (article L1122-2)).
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques
Bordeaux, 33000
Jerome Aupy, Jerome.aupy@chu-bordeaux.fr
- Recruiting
Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon
Bron, 69677
Sylvain Rheims, Sylvain.rheims@chu-lyon.fr
- Not yet recruiting
Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille
Lille, 59037
Philippe Derambure, Philippe.Derambure@chru-lille.fr
- Recruiting
Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone
Marseille, 13005
Fabrice Bartolomei, Fabrice.bartolomei@ap-hm.fr
- Not yet recruiting
Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne
Paris, 75014
Martine Gavaret, m.gavaret@ghu-paris.fr
- Not yet recruiting
Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033
Anca Nica, Anca.nica@chu-rennes.fr
- Not yet recruiting
Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet
Toulouse, 31059
Luc Valton, valton.l@chu-toulouse.fr
About this study
Official title: Model-based Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: A Cross-over Study of Efficacy
The goal of this clinical trial is to to obtain a significant decrease in seizure frequency in patients with refractory focal epilepsy after applying treatment of cathodal tDCS, compared to sham stimulation drug-resistant epileptic patient. The main questions it aims to answer are:
- Changes in quality of life
- Percent of newly reported side effects after the stimulation period
- Scores in epilepsy severity. Participants will be randomized in a cross-over, and will receive 10 days of tDCS or Sham. Each day will allow 2 periods of 20 minutes stimulation separated by 20 minutes off (with 40 minutes of cathodal stimulation total).
- Conditions
- Epilepsy, Drug Resistant Epilepsy
- Being tested
- transcranial direct current stimulation
- Keywords
- epilepsy, transcranial direct current stimulation, numerical models, quality of life
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Also called Research MRI, EEG
Research MRI includes 3D-T1 weighted MRI (3D-T1), diffusion MRI (dMRI), resting-state functional MRI (rsfMRI).
| Study group | Role | What they receive |
|---|---|---|
| tDCS - Sham | Other | Patient will be randomized to firstly receive tDCS (10 non consecutive days, 20 minutes twice a day with 20 minutes of break) and then Sham (10 non consecutive days, 20 minutes twice a day with 20 minutes of break). Receives: Device: transcranial direct current stimulation |
| Sham - tDCS | Other | Patient will be randomized to firstly receive Sham (10 non consecutive days, 20 minutes twice a day with 20 minutes of break) and then tDCS (10 non consecutive days, 20 minutes twice a day with 20 minutes of break). Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference.
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
Measured: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference.
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
Measured: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference.
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
Measured: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference.
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
Measured: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Secondary outcomes (24)
Evaluation of the number of responders (defined as patient with >50% of seizure reduction)
Proportion of responders evaluated after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study
Measured: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Evaluation of the number of responders (defined as patient with >50% of seizure reduction)
Proportion of responders evaluated after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study
Measured: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Evaluation of the number of responders (defined as patient with >50% of seizure reduction)
Proportion of responders evaluated after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study
Measured: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Evaluation of the number of responders (defined as patient with >50% of seizure reduction)
Proportion of responders evaluated after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study
Measured: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Evaluate the number of seizure-free patients
Number of seizure-free patients after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study
Measured: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Evaluate the number of seizure-free patients
Number of seizure-free patients after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study
Measured: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Evaluate the number of seizure-free patients
Number of seizure-free patients after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study
Measured: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Evaluate the number of seizure-free patients
Number of seizure-free patients after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study
Measured: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Quality of life after stimulation sessions with the baseline period
Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period
Measured: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Quality of life after stimulation sessions with the baseline period
Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period
Measured: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Quality of life after stimulation sessions with the baseline period
Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period
Measured: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Quality of life after stimulation sessions with the baseline period
Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period
Measured: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Evaluation of the change in seizure severity
Changes in the scores of epilepsy severity (NHS3) (investigator evaluation)
Measured: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Evaluation of the change in seizure severity
Changes in the scores of epilepsy severity (NHS3) (investigator evaluation)
Measured: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Evaluation of the change in seizure severity
Changes in the scores of epilepsy severity (NHS3) (investigator evaluation)
Measured: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Evaluation of the change in seizure severity
Changes in the scores of epilepsy severity (NHS3) (investigator evaluation)
Measured: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Changes in psychiatric comorbidities
Changes from baseline in depression (NDDI-E) and anxiety (GAD-7) scores
Measured: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Changes in psychiatric comorbidities
Changes from baseline in depression (NDDI-E) and anxiety (GAD-7) scores
Measured: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Changes in psychiatric comorbidities
Changes from baseline in depression (NDDI-E) and anxiety (GAD-7) scores
Measured: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Changes in psychiatric comorbidities
Changes from baseline in depression (NDDI-E) and anxiety (GAD-7) scores
Measured: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Safety assessment and possible side effects
Percent of newly reported side-effect during and after the stimulation period
Measured: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Safety assessment and possible side effects
Percent of newly reported side-effect during and after the stimulation period
Measured: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Safety assessment and possible side effects
Percent of newly reported side-effect during and after the stimulation period
Measured: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Safety assessment and possible side effects
Percent of newly reported side-effect during and after the stimulation period
Measured: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start18 Dec 2024
- Primary completion18 Dec 2026 (estimated)
- Study completion18 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Collaborators
- CRMBM-CEMEREM, Institut National de la Santé Et de la Recherche Médicale, France, Neuroelectrics Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334952
- Sponsor's protocol ID
- RCAPHM23_0074
- Other IDs
- ID-RCB
- Acronym
- GALVANI GS-3
- Status last verified
- Dec 2025
- First submitted
- 16 Mar 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model-based Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: A Cross-over Study of Efficacy
- ClinicalTrials.gov ID
- NCT06334952
- Acronym / sponsor ID
- GALVANI GS-3 / RCAPHM23_0074
- Conditions
- Epilepsy, Drug Resistant Epilepsy
- Keywords
- epilepsy, transcranial direct current stimulation, numerical models, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Collaborators
- CRMBM-CEMEREM, Institut National de la Santé Et de la Recherche Médicale, France, Neuroelectrics Corporation
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 18 Jan 2028 (estimated)
- First posted
- 28 Mar 2024 (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.
The goal of this clinical trial is to to obtain a significant decrease in seizure frequency in patients with refractory focal epilepsy after applying treatment of cathodal tDCS, compared to sham stimulation drug-resistant epileptic patient. The main questions it aims to answer are:
- Changes in quality of life
- Percent of newly reported side effects after the stimulation period
- Scores in epilepsy severity. Participants will be randomized in a cross-over, and will receive 10 days of tDCS or Sham. Each day will allow 2 periods of 20 minutes stimulation separated by 20 minutes off (with 40 minutes of cathodal stimulation total).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS - Sham | Other | Device: transcranial direct current stimulationPatient will be randomized to firstly receive tDCS (10 non consecutive days, 20 minutes twice a day with 20 minutes of break) and then Sham (10 non consecutive days, 20 minutes twice a day with 20 minutes of break). |
| Sham - tDCS | Other | Device: transcranial direct current stimulationPatient will be randomized to firstly receive Sham (10 non consecutive days, 20 minutes twice a day with 20 minutes of break) and then tDCS (10 non consecutive days, 20 minutes twice a day with 20 minutes of break). |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Patient, parents or legal representative who have given written informed consent;
- Age: ≥ 9 years;
- Patients with drug-resistant focal epilepsy with no evolutive brain lesion and no surgical indication or with a previous surgical failure, refusing surgery or with a planned surgery compatible with the total duration of this study;
- SEEG previously performed before inclusion with an adequate definition of the epileptogenic zone with all data required (pre-SEEG MRI, CT-scan or MRI with electrodes during SEEG and SEEG files) for personalization ;
- Patient having a pre-SEEG 3D-T1 MRI and CT-scan with electrodes during SEEG available; This MRI can be done specifically for this trial or might be reused from EPINOV or NEURO7T trial)
Key exclusion criteria (11 listed)
- Patients with seizures of generalized onset in the last 12 months;
- Patient with multifocal epileptogenic zones, bilateral epileptogenic zone, or poorly defined epileptogenic zone. The epileptogenic network should not be restricted to the orbito frontal cortex or cingulate cortex;
- Patients with psychogenic nonepileptic seizures;
- Patient presenting a contraindication to MRI 3T (patient having a pacemaker, metallic foreign bodies, non-removably implanted electronic medical devices, claustrophobia, inability to remain in supine position, vagus nerve stimulator even when switched off is a contraindication for MRI 3T. EPINOV or NEURO 7T trial patients, who have accepted for their data to be reused, can be included even while wearing a VNS device) ;
- Substance use abuse that may include alcohol , opioids (heroin, fentanyl) stimulants (Cocaine, methamphetamine) , hallucinogens (LSD, psilocybin (magic mushrooms), MDMA (Ecstasy))
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 stimulationAlso: Research MRI, EEGResearch MRI includes 3D-T1 weighted MRI (3D-T1), diffusion MRI (dMRI), resting-state functional MRI (rsfMRI). | Device | Sham - tDCS, tDCS - Sham |
Primary outcome
To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference.
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference.
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference.
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference.
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
24 secondary outcomes
Evaluation of the number of responders (defined as patient with >50% of seizure reduction)
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Evaluation of the number of responders (defined as patient with >50% of seizure reduction)
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Evaluation of the number of responders (defined as patient with >50% of seizure reduction)
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Evaluation of the number of responders (defined as patient with >50% of seizure reduction)
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Evaluate the number of seizure-free patients
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Evaluate the number of seizure-free patients
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Evaluate the number of seizure-free patients
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Evaluate the number of seizure-free patients
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Quality of life after stimulation sessions with the baseline period
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Quality of life after stimulation sessions with the baseline period
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Quality of life after stimulation sessions with the baseline period
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Quality of life after stimulation sessions with the baseline period
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Evaluation of the change in seizure severity
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Evaluation of the change in seizure severity
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Evaluation of the change in seizure severity
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Evaluation of the change in seizure severity
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Changes in psychiatric comorbidities
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Changes in psychiatric comorbidities
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Changes in psychiatric comorbidities
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Changes in psychiatric comorbidities
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Safety assessment and possible side effects
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Safety assessment and possible side effects
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Safety assessment and possible side effects
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Safety assessment and possible side effects
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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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.
7 sites 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 and Drug Resistant Epilepsy, run by Assistance Publique Hopitaux De Marseille at 7 sites 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 13 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrice Bartolomei, MD, PhD (0491384990 ext. 33, fabrice.bartolomei@ap-hpm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. (time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)). 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?
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 19 Dec 2025.