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

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 Overview

• Status: Recruiting
• Conditions: Cognitive Function; Focal Epilepsy; Neurophysiology; Electrodes, Implanted
• Intervention / Treatment: Device: Intracranial macro-microelectrode recording

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincent Navarro; Phone Number: 01 42 16 19 40; Email: vincent.navarro@aphp.fr
• Study Contact Backup: Name: Virginie Lambrecq; Phone Number: 0142161572; Email: Virginie.lambrecq@aphp.fr

Study Locations

• France
  • Paris, France, 7501F3
    • Recruiting
    • Hôpital de la Salpêtrière
    • Contact: Vincent NAVARRO, Pr; Phone Number: 01 42 16 19 40; Email: vincent.navarro@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of single unit changes at seizure emergence	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.	Whole duration of the clinical inverstigation, until 4 weeks
Identification of local field potential (LFP) changes at seizure emergence	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.	Whole duration of the clinical inverstigation, until 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2021
• Primary Completion (Estimated): February 27, 2029
• Study Completion (Estimated): February 27, 2031

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: EEG; Seizures; Microelectrodes
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Seizures; Epilepsies, Partial
• Other Study ID Numbers: C19-55; 2020-A00445-34 (Registry Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No