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

NCT04653012 | Recruiting

• 2 other identifiers: C19-552020-A00445-34
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Focal Epilepsy; Electrodes, Implanted; Cognitive Function; Neurophysiology

Keywords

Microelectrodes; Seizures; EEG

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Comparison of single unit activity before seizure according to brain localization

  Whole duration ofthe clinical inverstigation, until 4 weeks

• 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

Study Arms (1)

Macro-microelectrode implantation

EXPERIMENTAL

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

Interventions

Intracranial macro-microelectrode recording DEVICE

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

Macro-microelectrode implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Hôpital de la Salpêtrière

Paris, 7501F3, France

RECRUITING

MeSH Terms

Conditions

Epilepsies, Partial; Seizures

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Vincent Navarro

CONTACT

01 42 16 19 40; vincent.navarro@aphp.fr

Virginie Lambrecq

CONTACT

0142161572; Virginie.lambrecq@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: December 4, 2020
• Study Start: February 28, 2021
• Primary Completion (Estimated): February 27, 2029
• Study Completion (Estimated): February 27, 2031
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)