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Clinical Trials in France / NCT04653012
Recruiting Not applicable

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

NCT04653012 · tracked via the Priya Life Science France tracker
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Phase
Not applicable
Started
2021-02-28
Last updated
2026-09-28

Condition(s) studied

Focal EpilepsyElectrodes, ImplantedCognitive FunctionNeurophysiology

Investigational drug(s) / intervention(s)

Intracranial macro-microelectrode recording

Intracranial macro-microelectrode recording: Additionnally to clinical macroelectrodes, Benkhe-Fried depth macro-microelectrodes will be implanted and recorded during the pre-surgical investigation of epileptic patients

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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)

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Hôpital de la Salpêtrière Paris France Recruiting

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Other trials for the same condition

A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy Active, not recruiting
Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years Recruiting
An Open-label Study of XEN1101 in Epilepsy Enrolling by invitation
Atlas of Human Cognition by SEEG (MAPCOG-SEEG) Recruiting
Efficacy of Probenecid on Cluster Seizures During Anti Seizure Medication Withdrawal in Presurgical Focal Epilepsy Video-EEG Monitoring Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04653012 on ClinicalTrials.gov ↗ ← All trials in France