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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2020-A02861-38 |
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This project aims to conduct a pilot study based on the targeting of the epileptogenic zone previously localized very precisely by stereoelectroencephalography (SEEG). SEEG is used as part of the pre-surgical assessment. It consists, thanks to the intracerebral implantation of electrodes in the brain of patients, to perform an intracerebral electrophysiological recording and thus to precisely explore the epileptogenic regions.
In order to study the neuromodulatory and therapeutic effects of tDCS on epileptic brains, non-invasive techniques for measuring electrophysiological brain activity such as magnetoencephalography (MEG) and high-resolution electroencephalography (HR EEG) will be used.
Finally, since epilepsy is considered to be a disorder of brain functional networks associated with disturbed brain connectivity, the effects of tDCS on cortical excitability by studying the variations in functional connectivity induced by stimulation will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS (transcranial direct current stimulation) | Experimental | Patient will be treated for 3 cycles. A cycle is composed of 5 bi-sessions (one per day) of 20 minutes each. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | Patients will be treated using Starstim 8 device, a device allowing to perform transcranial direct current stimulation. The position of electrodes will be personalized based on the localization of the epileptogenic zone. |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure frequency | Percentage of change of seizures frequency | Comparison between baseline and month 2 |
| Seizure frequency | Percentage of change of seizures frequency | Comparison between baseline and month 4 |
| Seizure frequency | Percentage of change of seizures frequency | Comparison between baseline and month 6 |
| Seizure frequency | Percentage of change of seizures frequency | Comparison between baseline and month 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) - score to 6 to 24, higher values mean worse outcome | Comparison between baseline and month 8 |
| Anxiety disorders | Generalized Anxiety Disorder-7 (GAD-7) - score between 0 to 21, higher values mean worse outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Olivier Arnaud | AP-HM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Epileptologie et de Rythmologie Cérébrale | Marseille | 13005 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40347434 | Result | Bartolomei F, Daoud M, Delourme M, Tardoski S, Makhalova J, Bourguiba E, Medina Villalon S, Lagarde S, Wendling F, Ruffini G, Salvador R, Pizzo F, Giusiano B. Personalized multichannel transcranial direct current electrical stimulation (tDCS) in drug-resistant epilepsy: A SEEG based open-labeled study. Epilepsia Open. 2025 Aug;10(4):1034-1042. doi: 10.1002/epi4.70055. Epub 2025 May 10. |
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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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| Comparison between baseline and month 8 |
| Seizures evaluation | National Hospital Seizure Severity Scale (NHS3) - score 1 to 31, higher values mean worse outcome | Comparison between baseline and month 8 |
| Brain functional connectivity | National Hospital Seizure Severity Scale (NHS3) score 1 to 31, higher values mean worse outcome | Comparison between day 1 and day 5 of each session |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |