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NCT Number: NCT03912155

Multi-scale Analysis of Physiological Brain Networks

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location status: Recruiting

Location contact

Fabrice Bartolomei, PUPH

CONTACT

[email protected]

491384995 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-scale analysis of physiological brain networks

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.

Primary outcomes

  1. Rate of epileptic discharges

    Time frame: 2 hours

    Measurement of epileptic activity by electroencephalogram

  2. Rate of epileptic discharges

    Time frame: 2 hours

    Measurement of epileptic activity by magneto-encephalography

  3. Rate of epileptic discharges

    Time frame: 2 hours

    Measurement of epileptic activity by intracerebral stereotactic electroencephalogram

Study contacts

Contact information is provided by the study sponsor or research team.

Fabrice Bartolomei, PU-PH

CONTACT

[email protected]

491384995 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: SCALES

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2019
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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