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

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Patients for whom implanting intracerebral electrodes is underway

Exclusion Criteria:

  • Patients minors
  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: registration of intracerebral activity
epileptic patient receiving implantation of intracranial electrodes
Implanting electrode to measure brain activity
Implanting electrode to measure brain activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of epileptic discharges
Time Frame: 60 months
Measurement of epileptic activity by electroencephalogram
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimated)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

April 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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