Service d'Epileptologie et de Rythmologie Cérébrale
Marseille, 13005, France
NCT Number: NCT04782869
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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Notify Me12 year and older
All sexes
Interventional
Not applicable
Marseille, 13005, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Comparison between baseline and month 2
Percentage of change of seizures frequency
Time frame: Comparison between baseline and month 4
Percentage of change of seizures frequency
Time frame: Comparison between baseline and month 6
Percentage of change of seizures frequency
Time frame: Comparison between baseline and month 8
Percentage of change of seizures frequency
Time frame: Comparison between baseline and month 8
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) - score to 6 to 24, higher values mean worse outcome
Time frame: Comparison between baseline and month 8
Generalized Anxiety Disorder-7 (GAD-7) - score between 0 to 21, higher values mean worse outcome
Time frame: Comparison between baseline and month 8
National Hospital Seizure Severity Scale (NHS3) - score 1 to 31, higher values mean worse outcome
Time frame: Comparison between day 1 and day 5 of each session
National Hospital Seizure Severity Scale (NHS3) score 1 to 31, higher values mean worse outcome
Assistance Publique Hopitaux De Marseille
Other
Personalized Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: Evaluation of Therapeutic and Neurophysiological Effects
Acronym: GALVANI PS-1
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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