Multi-scale Analysis of Physiological Brain Networks (SCALES)

Multi-scale Analysis of Physiological and Pathological Brain Networks by Simultaneous EEG-MEG-SEEG Recordings

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Other: Multi-scale analysis of physiological brain networks

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.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Fabrice Bartolomei, PU-PH; Phone Number: +33 491384995; Email: fabrice.bartolomei@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: Fabrice Bartolomei, PUPH; Phone Number: +33 491384995; Email: fabrice.bartolomei@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The patients will be recruited in the Service of Epileptology and Cerebral Rhythmology of the Timone. Only major and minor control subjects will be recruited following the announcement of the experience by posting on different sites or other appropriate means of communication.

Description

Inclusion Criteria:

• Inclusion criteria for patients

  • 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

• Inclusion criteria for control subjects

  • 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of epileptic discharges	Measurement of epileptic activity by electroencephalogram	2 hours
Rate of epileptic discharges	Measurement of epileptic activity by magneto-encephalography	2 hours
Rate of epileptic discharges	Measurement of epileptic activity by intracerebral stereotactic electroencephalogram	2 hours

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Jean-Olivier ARNAUD, Director, Assistance Publique Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Estimated): April 15, 2024
• Study Completion (Estimated): May 2, 2024

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: EEG; MEG; SEEG
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 2018-51; 2018-A02363-52 RCB (Registry Identifier: APHM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No