Multi-scale Analysis of Physiological Brain Networks

NCT ID: NCT03912155

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2025-05-02

Brief Summary

The SEEG implantation is performed on purely clinical criteria for preoperative diagnosis. Magnetoencephalography and EEG are purely passive techniques that do not involve any additional risk. This project is a continuation of an existing project in which it was demonstrated the feasibility of simultaneous SEEG and MEG/EEG recordings.

Detailed Description

Brain function is based on the communication between sets of neurons at different spatial and temporal scales. The dysfunction of these networks is thus at the origin of several brain pathologies, including epilepsy. The recent improvement in recording methods paves the way for better characterization of brain networks, with several spatial and temporal resolutions, depending on the techniques used.

Still, several key points remain outstanding. First, several mechanisms can underlie the interaction between brain regions, and it remains to determine the most relevant tools in practice to quantify them. Second, there are difficulties in extracting these networks from surface recordings. The best strategies for studying these interactions in a non-invasive way therefore remain to be defined.

It will be propose to answer these questions based on simultaneous surface (magneto-encephalography/ electroencephalography) and depth (intracerebral stereotactic EEG, SEEG) recordings, a technique it was developed by the team of Marseille, in patients undergoing preoperative epilepsy assessment.

The primary objective is to find, among all the mechanisms of interaction between brain regions, which are most relevant in describing physiological and pathological brain networks.

The secondary objective is to test whether the visible coupling information at depth can be found from surface data (EEG, MEG) only. To do this, it will be compare the surface results with the SEEG results.

The SEEG implantation is performed on purely clinical criteria for preoperative diagnosis. Magnetoencephalography and EEG are purely passive techniques that do not involve any additional risk. This project is a continuation of an existing project in which we have demonstrated the feasibility of simultaneous SEEG and MEG/EEG recordings.

Conditions

Epilepsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

20 patients per presumed location of the epileptogenic zone (see experimental plan) for a total of 120 patients, including 30 minors. For patients, a MEG-EEG-SEEG examination during the SEEG exploration period.

Multi-scale analysis of physiological brain networks

Intervention Type: OTHER

It will be simultaneously record the surface EEG, the MEG and in patients only the intracerebral EEG (SEEG). In the case of SEEG with micro contacts, these additional signals will also be recorded in parallel and will provide greater sensitivity to high frequency activities. The physiological networks will be studied in patients thanks to stimulations (external or intracerebral) carried out within the framework of the functional cartography, and the pathological networks thanks to measures in state of rest. For external stimulation protocols, it will be constitute a reference base in MEG and EEG alone (non-invasive) on control subjects.

Controles

For the control population, 120 control subjects, including 30 minors, that is to say as many as patients. For control subjects, a MEG-EEG exam.

Multi-scale analysis of physiological brain networks

Intervention Type: OTHER

It will be simultaneously record the surface EEG, the MEG and in patients only the intracerebral EEG (SEEG). In the case of SEEG with micro contacts, these additional signals will also be recorded in parallel and will provide greater sensitivity to high frequency activities. The physiological networks will be studied in patients thanks to stimulations (external or intracerebral) carried out within the framework of the functional cartography, and the pathological networks thanks to measures in state of rest. For external stimulation protocols, it will be constitute a reference base in MEG and EEG alone (non-invasive) on control subjects.

Interventions

Multi-scale analysis of physiological brain networks

It will be simultaneously record the surface EEG, the MEG and in patients only the intracerebral EEG (SEEG). In the case of SEEG with micro contacts, these additional signals will also be recorded in parallel and will provide greater sensitivity to high frequency activities. The physiological networks will be studied in patients thanks to stimulations (external or intracerebral) carried out within the framework of the functional cartography, and the pathological networks thanks to measures in state of rest. For external stimulation protocols, it will be constitute a reference base in MEG and EEG alone (non-invasive) on control subjects.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients for whom intracerebral electrode implantation is in progress as part of the pre-surgical evaluation of their drug-resistant partial epilepsy.
• Patient informed, expressing his non-opposition (or legal representative (s), affiliated to a social security scheme
• The medical examination is carried out as part of the medical follow-up of these patients

• Informed subject, expressing his non-opposition or legal representative, affiliated to a social security scheme

Exclusion Criteria

Minors under 12 years

• Pregnant or lactating women,
• The adults under guardianship or under the protection of justice
• Non-beneficiaries of a social security scheme
• Persons deprived of their liberty by a judicial or administrative decision
• Absence of informed consent

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Olivier ARNAUD, Director

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Fabrice Bartolomei, PU-PH

Role: CONTACT

fabrice.bartolomei@ap-hm.fr

491384995 ext. +33

Facility Contacts

Fabrice Bartolomei, PUPH

Role: primary

fabrice.bartolomei@ap-hm.fr

491384995 ext. +33

Other Identifiers

2018-A02363-52 RCB

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-51

Identifier Type: -

Identifier Source: org_study_id