Personalized electrical stimulation for drug-resistant epilepsy

Model-based Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: A Cross-over Study of Efficacy

This study is testing if a personalized electrical stimulation treatment can help people with drug-resistant epilepsy have fewer seizures and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 9 Years and up
• Sex: All
• Sponsor: Assistance Publique Hopitaux De Marseille (Academic / other)
• Locations: 7 sites (Bordeaux and 6 other locations)
• Trial ID: NCT06334952 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of personalized transcranial direct current stimulation (tDCS) in reducing seizure frequency in patients with drug-resistant focal epilepsy. Participants will be randomly assigned to receive either active tDCS or sham stimulation over a period of 10 days, with sessions consisting of two 20-minute stimulation periods each day. The study will also assess changes in quality of life, the incidence of side effects, and epilepsy severity scores. The goal is to determine if this innovative approach can provide significant benefits compared to standard care.

Who should consider this trial

Good fit: Ideal candidates include patients aged 9 years and older with drug-resistant focal epilepsy who have undergone previous evaluations and have not responded to standard treatments.

Not a fit: Patients with epilepsy that is amenable to surgical intervention or those who have not experienced a sufficient number of seizures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce seizure frequency and improve the quality of life for patients with drug-resistant epilepsy.

How similar studies have performed: While the use of tDCS in epilepsy is a relatively novel approach, preliminary studies have shown promise in similar applications, indicating potential for success.

Eligibility criteria

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)).

Where this trial is running

Bordeaux and 6 other locations

• Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques — Bordeaux, France (Recruiting)
• Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon — Bron, France (Recruiting)
• Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille — Lille, France (Not_yet_recruiting)
• Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone — Marseille, France (Recruiting)
• Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne — Paris, France (Not_yet_recruiting)
• Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou — Rennes, France (Not_yet_recruiting)
• Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet — Toulouse, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Fabrice Bartolomei, MD, PhD

Conditions Epilepsy; Drug Resistant Epilepsy; epilepsy; transcranial direct current stimulation; numerical models; quality of life