Multi-scale Analysis of Physiological Brain Networks

Epilepsy Clinical Trial

— SCALES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03912155
• Other study ID #: 2018-51
• Secondary ID: 2018-A02363-52 R
• Status: Recruiting
• Start date: April 15, 2019
• Est. completion date: May 2, 2024

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Fabrice Bartolomei, PU-PH
• Phone: 491384995
• Email: fabrice.bartolomei[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 2, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of epileptic discharges	Measurement of epileptic activity by electroencephalogram	2 hours
Primary	Rate of epileptic discharges	Measurement of epileptic activity by magneto-encephalography	2 hours
Primary	Rate of epileptic discharges	Measurement of epileptic activity by intracerebral stereotactic electroencephalogram	2 hours