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

NCT06334952 | Recruiting DMC

• 2 other identifiers: RCAPHM23_0074ID-RCB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief 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. 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

Keywords

epilepsy; transcranial direct current stimulation; numerical models; quality of life

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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)

  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)

  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)

  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)

  V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)

• Evaluate the number of seizure-free patients

  Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)

Other Outcomes (6)

• Compare brain functional connectivity before and after tDCS treatment

  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)

  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

  Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)

Study Arms (2)

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).

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).

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

Research MRI includes 3D-T1 weighted MRI (3D-T1), diffusion MRI (dMRI), resting-state functional MRI (rsfMRI).

Also known as: Research MRI, EEG

Sham - tDCS; tDCS - Sham

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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
• 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.

You may not qualify if:

• 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
• 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)).

Sponsors & Collaborators

• CRMBM-CEMEREM: collaborator
• Neuroelectrics Corporation: collaborator
• Assistance Publique Hopitaux De Marseille: lead
• Institut National de la Santé Et de la Recherche Médicale, France - LTSI: collaborator

Study Sites (7)

Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques

Bordeaux, 33000, France

RECRUITING

Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon

Bron, 69677, France

RECRUITING

Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille

Lille, 59037, France

NOT YET RECRUITING

Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone

Marseille, 13005, France

RECRUITING

Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne

Paris, 75014, France

NOT YET RECRUITING

Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou

Rennes, 35033, France

NOT YET RECRUITING

Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet

Toulouse, 31059, France

NOT YET RECRUITING

MeSH Terms

Conditions

Epilepsy; Drug Resistant Epilepsy

Interventions

Transcranial Direct Current Stimulation; Electroencephalography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Fabrice Bartolomei, MD, PhD

CONTACT

0491384990; fabrice.bartolomei@ap-hpm.fr

Sophie Tardoski

CONTACT

0491381594; sophie.tardoski@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 28, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): January 18, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)