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

NCT ID: NCT04653012

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2031-02-27

Brief Summary

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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

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Conditions

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Focal Epilepsy Electrodes, Implanted Cognitive Function Neurophysiology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Intracranial macro-microelectrode recording

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital de la Salpêtrière

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Vincent Navarro

Role: CONTACT

01 42 16 19 40

Virginie Lambrecq

Role: CONTACT

0142161572

Facility Contacts

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Vincent Navarro, Pr

Role: primary

01 42 16 19 40

Other Identifiers

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2020-A00445-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

C19-55

Identifier Type: -

Identifier Source: org_study_id

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