Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy

Study Overview
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Brief Summary
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Drug-resistant partial epilepsy has a heavy impact on quality of life and sometimes on life expectancy itself. Only a minority of patients may benefit from a curative epilepsy surgery. Neurostimulation, which can be an effective add-on treatment, is currently mainly represented by vagus nervus stimulation. Transcranial direct current stimulation, a non -invasive technique already used in other areas of neurology, may be efficient on some partial epilepsies, in particular through the individual configuration of stimulation, made possible by recent technological advances. Main goal : To study the effect of transcranial electrical stimulation on the frequency of seizures in patients with drug-resistant partial epilepsy. Hypothesis : Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation.

Official Title
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BRAINSTIM : Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy

Conditions
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Epilepsy

Intervention / Treatment
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* Device: STARSTIM
* Device: sham TDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 15 years; Patients with drug-partial resistant epilepsy with the following characteristics: Disabling epilepsy despite an optimized pharmacological treatment. An average of one seizure a day or more during the week preceding the inclusion Focal epilepsy in which epileptogenic zone is documented by paraclinical examinations consistent with clinical data Existence of measurable EEG markers of epilepsy Anti-epileptic drug treatment unmodified during the 2 weeks preceding the inclusion no change to treatment planned during the study. Signed informed consent. Exclusion Criteria: Patients under 15 years; Patients in which a standard quality EEG recording is not possible Patients with ictal bradycardia or ictal syncope ; Patients with heart disease which may result in heart arrhythmia ; Incapacitated patients (curatorship, guardianship), patients deprived of liberty. Pregnant or lactating women Vagus nervus stimulation is not an exclusion criteria

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TDCS session<br>Intervention : Stimulation is applied during a 60 min session with STARSTIM | Device: STARSTIM<br>* Multifocal transcranial direct current stimulation. CE-marked device, comprising a cap with 2 to 8 electrodes, connected with a programmable mobile stimulator. The stimulation is applied during a 60 min session<br>* Other names: TDCS TransCranial Direct Current Stimulation;|
| Placebo Comparator: TDCS Placebo<br>Intervention : Stimulation is not applied during a 60 min session with STARSTIM | Device: sham TDCS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical : - Significant reduction of the frequency of occurrence of seizures within 24 hours, 48 hours, and 7 days following a session of TDCS. |  | 24 hours until 7 days | 
| Clinical : - Reduction in the duration of seizures |  | 6 months | 
| Electrophysiological : Decrease of epileptic EEG paroxysms at 8 and 24 hours after a TDCS session |  | 8-24 hours | 
| - Clinical : If appropriate, reduction of the frequency of occurrence of secondary generalized seizures. |  | 6 months | 
| -Clinical : Improvement in the quality of life within 7 days following a TDCS session |  | 7 days | 
| Electrophysiological : - Decrease of epileptic EEG paroxysms immediately following a TDCS session. |  | up to 1 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Direct Current Stimulation