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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2021-A00529-32 |
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Transcranial current stimulation (tCS), a safe, tolerable technique employing weak currents (~ 1 mA) applied to the scalp, has been shown to be a promising technique in alleviating seizures in focal epilepsy patients. Although studies reveal a decrease in the epileptiform activity due to tCS, this field lacks a quantification of neurophysiological changes during and immediately after stimulation. The investigators hypothesise that tCS can effectively reduce the amplitude and rate of interictal spikes as well as the functional connectivity between regions during and immediately after stimulation. It is thus planned to deliver an extensive quantitative description of the tCS effects on interictal spike activity, functional connectivity and other tissue biomarkers, using the simultaneous recording of intracranial signals during tCS. Moreover, the investigators seek to compare these variations between different tCS paradigms (direct current -tDCS- vs alternate current -tACS- stimulation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS | Experimental | Patients receiving tDCS during SEEG investigation |
|
| tACS | Experimental | Patients receiving tACS during SEEG intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial stimulation | Device | Patients will receive either direct current stimulation or alternate stimulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure of epileptogenic markers in intracranial brain signals recordings | Rate and amplitude of interictal epileptogenic spikes | During tDCS or tACS |
| Measure of epileptogenic markers in intracranial brain signals recordings | Rate and amplitude of interictal epileptogenic spikes | After tDCS or tACS |
| Measure of functional connectivity in intracranial brain signals recordings | Neural network excitability | During tDCS or tACS |
| Measure of functional connectivity in intracranial brain signals recordings | Neural network excitability | After tDCS or tACS |
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Inclusion Criteria:
Exclusion Criteria:
Difficulty to read or understand the French language, or inability to understand the information regarding the study
Person protected by articles L1121-5, L1121-6 and L1121-8 of Public Health Code (pregnant or breastfeeding woman, deprived of liberty by judicial decision, situations of social fragility, adults or unable to express their consent). Pregnancy will be evaluated during screening with a urine pregnancy test.
Presence of severe negative outcome of SEEG surgery preventing the acquisition of SEEG data (i.e. hemorragic complications, subcutaneous infection), at the time of inclusion.
Patient showing contraindications for electric stimulation at the time of inclusion:
(A) Patient with unstable or non-controlled neuropsychiatric illness (B) Patients having cardiac or medication implants (C) Patients with implanted pacemakers (D) Patients with serious brain injury (E) Patients showing damage of skin at sites of stimulation
Any condition that, according to the investigator, is not compatible with carrying out the study
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| Name | Affiliation | Role |
|---|---|---|
| François CREMIEUX | AP-HM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service Epileptologie et Rythmologie Cérébrale | Marseille | 13005 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39182340 | Result | Simula S, Makhalova J, Pizzo F, Garnier E, Damiani G, Mercadal B, Chiara Biagi M, Salvador R, Medina-Villalon S, Ruffini G, Wendling F, George Benar C, Bartolomei F. Impact of transcranial electrical stimulation on simultaneous stereoelectroencephalography recordings: A randomized sham-controlled study. Clin Neurophysiol. 2024 Oct;166:211-222. doi: 10.1016/j.clinph.2024.08.003. Epub 2024 Aug 14. |
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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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