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Tests treatment safety and results for Epilepsy
Official title Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic
ClinicalTrials.gov ID: NCT06334952
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 and older
You may be able to join 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...
- SEEG previously performed before inclusion with an adequate definition of the epileptogenic zone with all data required (pre-SEEG MRI, CT-scan or MRI...
- 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...
You likely can't join 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...
- Patients with psychogenic nonepileptic seizures;
- Patient presenting a contraindication to MRI 3T (patient having a pacemaker, metallic foreign bodies, non-removably implanted electronic medical...
- Substance use abuse that may include alcohol , opioids (heroin, fentanyl) stimulants (Cocaine, methamphetamine) , hallucinogens (LSD, psilocybin...
- Patient presenting a serious intercurrent pathology and/or a progressive brain tumor
See the full eligibility criteria
- 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...
- 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
- 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.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Bron, France
- Lille, France
- Marseille, France
- Paris, France
- Rennes, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Bron, France; Lille, France; Marseille, France; Paris, France; Rennes, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.