Could a gentle brain zap tame Hard-to-Treat seizures?
NCT ID NCT06334952
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a non-invasive brain stimulation technique called tDCS can reduce seizures in people with drug-resistant epilepsy. About 60 participants will receive either real or sham (fake) stimulation over 10 days. The goal is to see if this approach safely lowers seizure frequency and improves quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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9 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon
RECRUITINGBron, 69677, France
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Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet
NOT_YET_RECRUITINGToulouse, 31059, France
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Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone
RECRUITINGMarseille, 13005, France
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Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou
NOT_YET_RECRUITINGRennes, 35033, France
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Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques
RECRUITINGBordeaux, 33000, France
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Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne
NOT_YET_RECRUITINGParis, 75014, France
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Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille
NOT_YET_RECRUITINGLille, 59037, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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