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Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings. (MEG-SEEG)

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electroencephalogram
magnetoencephalogram
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients for whom implanting intracerebral electrodes is underway

Exclusion Criteria:

  • Patients minors
  • Pregnant or lactating women

Sites / Locations

  • Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

registration of intracerebral activity

Arm Description

epileptic patient receiving implantation of intracranial electrodes

Outcomes

Primary Outcome Measures

The number of epileptic discharges
Measurement of epileptic activity by electroencephalogram

Secondary Outcome Measures

Full Information

First Posted
August 12, 2016
Last Updated
April 10, 2019
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02875964
Brief Title
Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings.
Acronym
MEG-SEEG
Official Title
Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Presurgical evaluation of epileptic patients require a precise mapping of cerebral regions implied in epileptic discharges and in normal function. The current practice in most cases is to implant intracerebral electrodes in order to localize these regions in a reliable manner. However, non-invasive methods have been developed in order to record brain activity with no risk for the patient. Still, it is necessary to validate and improve the signal processing methods and the underlying models these methods in order to optimize their use in clinical practice. To do so, it is necessary to record simultaneously electroencephalogram (EEG) and magnetoencephalogram (MEG) and stereo encephalogram SEEG (intracerebral). Such simultaneous recordings will permit to confront the exact same activity recorded non-invasively at the surface of the head, and represented on the brain thanks to the model and directly within the brain. The objective is to define the conditions under which one can represent faithfully the activity measured intracerebrally from the surface measurements. It will be record simultaneously MEG, scalp EEG and intracerebral EEG on a series of 60 patients. It will be record resting state signals, as well as stimulation protocols. The interictal epileptic discharges will be marked on the different modalities, and evoked potentials/fields computed in response to protocols. Sensitivity of recordings to activity visible on depth recordings will be evaluated as a function of localization of brain generators. Advanced signal processing methods will be used such as source localization and independent component analysis, in order to increase sensitivity of measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
registration of intracerebral activity
Arm Type
Experimental
Arm Description
epileptic patient receiving implantation of intracranial electrodes
Intervention Type
Device
Intervention Name(s)
electroencephalogram
Intervention Description
Implanting electrode to measure brain activity
Intervention Type
Device
Intervention Name(s)
magnetoencephalogram
Intervention Description
Implanting electrode to measure brain activity
Primary Outcome Measure Information:
Title
The number of epileptic discharges
Description
Measurement of epileptic activity by electroencephalogram
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients for whom implanting intracerebral electrodes is underway Exclusion Criteria: Patients minors Pregnant or lactating women
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings.

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