Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients

Not Applicable

Recruiting

• Conditions: Electrodes, Implanted; Cognitive Function; Neurophysiology; Focal Epilepsy
• Interventions: Device: Intracranial macro-microelectrode recording

• Registration Number: NCT04653012
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-25
• Study First Posted: 2020-12-04
• Study Start: 2021-02-28
• Status Verified: 2024-07
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-07
• Primary Completion: 2029-02-27
• Study Completion: 2031-02-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Macro-microelectrode implantation	Intracranial macro-microelectrode recording	Implantation of macro-micro electrodes of the Adtech Benkhe-Fried type in epileptic patients who are undergoing evaluation with intracranial EEG electrodes

Primary Outcome Measures

Name	Time	Method
Identification of single unit changes at seizure emergence	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	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 Outcome Measures

Name	Time	Method
Identification of single unit changes during physiological brain activity	Whole duration ofthe clinical inverstigation, until 4 weeks	We will compare firing rates during resting states and stimulus induced states.; We expect to observe significant changes in firing rate between states.
Identification of LFP power changes during physiological brain activity	Whole duration ofthe clinical inverstigation, until 4 weeks	We will compare LFP power during resting states and stimulus induced states.; We expect to observe significant changes in LFP power between states.
Multilevel study of brain activity	Whole duration ofthe clinical inverstigation, until 4 weeks	We will look for correlation between firing rates and LFP power changes.
Comparison of single unit activity before seizure according to brain localization	Whole duration ofthe clinical inverstigation, until 4 weeks	We will compare firing rate before seizure according to brain regions (anatomy and involvement in the seizure onset zone)

Trial Locations

Locations (1)

Hôpital de la Salpêtrière; 🇫🇷 Paris, France