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Multi-scale Analysis of Physiological Brain Networks

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ClinicalTrials.gov Identifier: NCT03912155
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease Intervention/treatment
Patients Only Intracerebral EEG 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Multi-scale Analysis of Physiological and Pathological Brain Networks by Simultaneous EEG-MEG-SEEG Recordings
Estimated Study Start Date : May 28, 2019
Estimated Primary Completion Date : May 2, 2024
Estimated Study Completion Date : May 2, 2024

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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912155


Contacts
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Contact: Fabrice Bartolomeï, PU-PH 491384995 ext +33 fabrice.bartolomeï@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Fabrice Bartolomeï, PUPH    491384995 ext +33    fabrice.bartolomeï@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD, Director Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03912155     History of Changes
Other Study ID Numbers: 2018-51
2018-A02363-52 RCB ( Registry Identifier: APHM )
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No