Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Identification of single unit changes at seizure emergence
Study Overview
Brief Summary
The main goal of this project is to study the mechanisms of epileptic activities using intracranial macro and micro electrodes in epileptic patients undergoing pre-surgical investigation.
The recordings will also be used to study physiological mechanisms like sleep and different cognitive functions.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Contraindication for an intracranial investigation (with macro-electrodes) : intercurrent infectious syndrome, decompensated associated pathology (cardiac, pulmonary, renal, hepatic), patient with increased risk of infection (ex: under immunosuppressive therapy)
- •Pregnant or parturient woman
- •Breastfeeding woman
- •Minor person or legally protected adult (tutelage, legal guardianship, maintenance of justice)
Arms & Interventions
Macro-microelectrode implantation
Implantation of macro-micro electrodes of the Adtech Benkhe-Fried type in epileptic patients who are undergoing evaluation with intracranial EEG electrodes
Intervention: Intracranial macro-microelectrode recording (Device)
Outcomes
Primary Outcomes
Identification of single unit changes at seizure emergence
Time Frame: Whole duration of the clinical inverstigation, until 4 weeks
In order to identify biomarkers of epileptic seizures we will study single neuron activities (firing rate) using spike sorting at different time periods (before, during and after seizures and during interictal periods) We expect to observe significant changes in firing rate across the different time periods.
Identification of local field potential (LFP) changes at seizure emergence
Time Frame: Whole duration of the clinical inverstigation, until 4 weeks
In order to identify biomarkers of epileptic seizures we will study LFP power using time frequency analysis at different time periods (before, during and after seizures and during interictal periods) We expect to observe significant changes in LFP power across the different time periods.
Secondary Outcomes
- Identification of single unit changes during physiological brain activity(Whole duration ofthe clinical inverstigation, until 4 weeks)
- Identification of LFP power changes during physiological brain activity(Whole duration ofthe clinical inverstigation, until 4 weeks)
- Multilevel study of brain activity(Whole duration ofthe clinical inverstigation, until 4 weeks)
- Comparison of single unit activity before seizure according to brain localization(Whole duration ofthe clinical inverstigation, until 4 weeks)