Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic (GALVANI GS-3)

December 13, 2025 updated by: Assistance Publique Hopitaux De Marseille

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques
        • Contact:
      • Bron, France, 69677
        • Recruiting
        • Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon
        • Contact:
      • Lille, France, 59037
        • Not yet recruiting
        • Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille
        • Contact:
      • Marseille, France, 13005
        • Recruiting
        • Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone
        • Contact:
      • Paris, France, 75014
        • Not yet recruiting
        • Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne
        • Contact:
      • Rennes, France, 35033
        • Not yet recruiting
        • Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou
        • Contact:
      • Toulouse, France, 31059
        • Not yet recruiting
        • Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient, parents or legal representative who have given written informed consent;
  2. Age: ≥ 9 years;
  3. 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;
  4. 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 ;
  5. 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)
  6. For patients with VNS, experiencing no response or partial response, and for whom the stimulation parameters have been stable for at least 6 months
  7. A research MRI scan that is suitable for navigated brain stimulation (NBS) and generation of electrical fields including dMRI for tractography;
  8. Number of seizures ≥3/month during the baseline (before the first session of tDCS treatment);
  9. Patient having stable medications for epilepsy 4 weeks before the baseline (except rescue treatment);
  10. Patient's IQ, which in the investigator's opinion will enable questionnaires and neuropsychological assessments to be carried out;
  11. Patient able to understand, speak and write in French;
  12. Patient able to follow study's procedure;
  13. Patient beneficiary or affiliated to a health insurance plan.

Exclusion Criteria:

  1. Patients with seizures of generalized onset in the last 12 months;
  2. 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;
  3. Patients with psychogenic nonepileptic seizures;
  4. 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) ;
  5. Substance use abuse that may include alcohol , opioids (heroin, fentanyl) stimulants (Cocaine, methamphetamine) , hallucinogens (LSD, psilocybin (magic mushrooms), MDMA (Ecstasy))
  6. Patient presenting a serious intercurrent pathology and/or a progressive brain tumor
  7. Patient having damaged skin or scalp that may interfere with tDCS stimulation (e.g., eczema, lesion);
  8. 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)
  9. 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;
  10. 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 ;
  11. 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)).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: tDCS - Sham
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).
Device: transcranial direct current stimulation
Research MRI includes 3D-T1 weighted MRI (3D-T1), diffusion MRI (dMRI), resting-state functional MRI (rsfMRI).
Other Names:
  • Research MRI, EEG
Other: Sham - tDCS
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).
Device: transcranial direct current stimulation
Research MRI includes 3D-T1 weighted MRI (3D-T1), diffusion MRI (dMRI), resting-state functional MRI (rsfMRI).
Other Names:
  • Research MRI, EEG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period
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)
Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period
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)
Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period
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)
Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period
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)
Changes in the scores of epilepsy severity (NHS3) (investigator evaluation)
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)
Changes in the scores of epilepsy severity (NHS3) (investigator evaluation)
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)
Changes in the scores of epilepsy severity (NHS3) (investigator evaluation)
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 the scores of epilepsy severity (NHS3) (investigator evaluation)
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 from baseline in depression (NDDI-E) and anxiety (GAD-7) scores
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 from baseline in depression (NDDI-E) and anxiety (GAD-7) scores
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 from baseline in depression (NDDI-E) and anxiety (GAD-7) scores
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)
Changes from baseline in depression (NDDI-E) and anxiety (GAD-7) scores
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)
Percent of newly reported side-effect during and after the stimulation period
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)
Percent of newly reported side-effect during and after the stimulation period
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)
Percent of newly reported side-effect during and after the stimulation period
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)
Percent of newly reported side-effect during and after the stimulation period
V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare brain functional connectivity before and after tDCS treatment
Time Frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Changes in functional connectivity measured by fMRI and EEG signal 4 weeks after the tDCS periods in comparison with baseline period
V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Evaluation of the impact of tDCS on interictal epileptic spikes (IESs)
Time Frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Change in the number of IESs per time unit after each tDCS session in comparison with baseline period
Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Evaluation of the impact of tDCS on interictal epileptic spikes
Time Frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Change in localization and extent of brain areas involved in IESs before and after each tDCS session in comparison with baseline period
Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Evaluation of the impact of tDCS on interictal epileptic spikes
Time Frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Change in localization and extent of brain areas involved in IESs before and after each tDCS session in comparison with baseline period
V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Evaluation of the impact of tDCS on interictal epileptic spikes
Time Frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Changes in strength and density of functional links during IES before and after each tDCS session
Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Evaluation of the impact of tDCS on interictal epileptic spikes
Time Frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Changes in strength and density of functional links during IES before and after each DCS session
V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique Hopitaux De Marseille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Neuroelectrics Corporation
CRMBM-CEMEREM
Institut National de la Santé Et de la Recherche Médicale, France - LTSI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCAPHM23_0074
  • ID-RCB (Other Identifier: 2023-A01756-39)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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