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

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Mar 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called transcranial direct current stimulation (tDCS) to see if it can help reduce the number of seizures in patients with drug-resistant epilepsy. Specifically, the trial will compare the effects of real tDCS treatment with a sham (fake) treatment to find out if it really makes a difference. Researchers will also look at how this treatment affects the quality of life for participants, any side effects they might experience, and how severe their epilepsy is.

To be eligible for the study, participants need to be at least 9 years old and have epilepsy that doesn't respond to standard medications. They also need to have had specific tests done before joining, and their seizures must occur at least three times a month. Throughout the study, participants will receive either the real treatment or the sham treatment for ten days, with daily sessions of stimulation. It’s important to know that there are certain health conditions and situations that would prevent someone from joining the trial, such as having specific medical devices or severe health issues. Overall, this trial aims to find a potentially helpful new treatment for those struggling with epilepsy that doesn't respond to usual therapies.

Gender

ALL

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 surgical indication or with a previous surgical failure, refusing surgery or with a planned surgery compatible with the total duration of this study;
• • 4. 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;
• • 6. A research MRI scan that is suitable for navigated brain stimulation (NBS) and generation of electrical fields including dMRI for tractography;
• • 7. Number of seizures ≥3/month during the baseline (before the first session of tDCS treatment);
• • 8. Patient having stable medications for epilepsy 4 weeks before the baseline (except rescue treatment);
• • 9. Patient's IQ, which in the investigator's opinion will enable questionnaires and neuropsychological assessments to be carried out;
• • 10. Patient able to understand, speak and write in French;
• • 11. Patient able to follow study's procedure;
• • 12. 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) ;
• • 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)).