Actively Recruiting
Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2025-09-08
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the mechanisms behind epileptic activities by using intracranial macro and micro electrodes in patients with focal drug-resistant epilepsy who are undergoing pre-surgical evaluation. This study also aims to explore physiological brain functions such as sleep and cognition alongside epilepsy-related brain activity. The research is led by the Institut National de la Santé Et de la Recherche Médicale in France. The study involves implanting Benkhe-Fried type macro-micro electrodes alongside clinical macroelectrodes in patients during their pre-surgical assessment with intracranial EEG monitoring. These implanted electrodes will record brain activity at multiple levels throughout the clinical investigation, which can last up to four weeks. Participants will be closely monitored during their hospital stay, with continuous recordings capturing single unit and local field potential changes especially at seizure onset and during normal brain function. Researchers will analyze these recordings to understand brain activity related to seizures and physiological states. The total observation and monitoring period can extend up to four weeks during the pre-surgical evaluation phase.
CONDITIONS
Brief Title
Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with focal drug-resistant epilepsy
- Patients who undergo a presurgical evaluation with intracranial electrodes in the videoEEG unit of the Neurology department at the Pitié-Salpêtrière hospital
- Patients who have been informed and provided written informed consent to take part in the study
You will not qualify if you...
- Contraindication for an intracranial investigation (with macro-electrodes) such as intercurrent infectious syndrome, decompensated associated pathology (cardiac, pulmonary, renal, hepatic), or increased risk of infection (e.g., under immunosuppressive therapy)
- Pregnant or parturient woman
- Breastfeeding woman
- Minor person or legally protected adult (tutelage, legal guardianship, maintenance of justice)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 4 weeks
Participants undergo implantation of macro-micro electrodes as part of their intracranial EEG evaluation.
During the clinical investigation period in the videoEEG unit
Trial Site Locations
Total: 1 location
1
Hôpital de la Salpêtrière
Paris, France, 7501F3
Actively Recruiting
Research Team
V
Vincent Navarro
V
Virginie Lambrecq
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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