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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TDCS session | Experimental | Intervention : Stimulation is applied during a 60 min session with STARSTIM |
|
| TDCS Placebo | Placebo Comparator | Intervention : Stimulation is not applied during a 60 min session with STARSTIM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STARSTIM | Device | Multifocal transcranial direct current stimulation.
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BIRABEN Arnaud | Rennes HU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Neurologie | Rennes | 35000 | France |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| sham TDCS | Device |
|
| 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 |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |