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Simultaneous MEG or fMRI And INtracranial EEG (SEMAINE)

Primary Purpose

Epilepsy, Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MEG or fMRI And INtracranial EEG
fMRI
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy focused on measuring Epilepsy surgery, High frequency activity, icEEG, fMRI, MEG

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients aged between 18 and 60 years, not subject of any measure of legal protection
  • Patients suffering from drug resistant partial epilepsy
  • Patient undergoing intracranial video EEG
  • Patients with electrodes implanted in orthogonal
  • no MRI cons-indication
  • Patients who signed a consent form
  • Intellectual capacity to perform cognitive tasks and to sign an informed consent.
  • Affiliation to social security

Exclusion Criteria:

  • Pregnant women
  • Elderly patients under 18 or over 60 years Patient not suffering from drug resistant partial epilepsy, or not scheduled for a SEEG
  • MRI cons-indication
  • Patients taking psychotropics drugs
  • Claustrophobia
  • Inability to perform cognitive tasks or to give informed consent.

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient

Volunteers

Arm Description

Outcomes

Primary Outcome Measures

Blood Oxygenation Level Dependent changes, associated with intracranial EEG signal, as determined by simultaneous fMRI and icEEG
fMRI correlates of epileptic and cognitive-induced high-frequency activities
MEG signal, associated with intracranial EEG signal, as determined by simultaneous MEG and icEEG
MEG correlates of epileptic and cognitive-induced high-frequency activities

Secondary Outcome Measures

Full Information

First Posted
October 6, 2014
Last Updated
February 1, 2018
Sponsor
Hospices Civils de Lyon
Collaborators
University of Konstanz
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1. Study Identification

Unique Protocol Identification Number
NCT02342938
Brief Title
Simultaneous MEG or fMRI And INtracranial EEG
Acronym
SEMAINE
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 16, 2013 (Actual)
Primary Completion Date
May 18, 2017 (Actual)
Study Completion Date
May 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
Collaborators
University of Konstanz

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The SEMAINE project will investigate intracranial EEG (icEEG) simultaneously recorded with either fMRI or MEG to 1) improve identification of the epileptogenic zone in patients suffering from drug-resistant partial epilepsy, and 2) define the functional organization of neural networks underlying human perception and cognition in order to prevent inadvertent deficits resulting from neurosurgical resection. In particular, high-frequency activity (HFA), as measured with icEEG, has been demonstrated in recent years as a relevant index for both epileptogenic tissue and healthy cortical processing, but its correlates in fMRI and MEG require further investigation. This will be a pioneering effort in several respects, as the first to directly measure high-frequency neural activity in tandem with fMRI, and among the first to do so with MEG. In addition to their attractiveness as noninvasive imaging techniques, fMRI and MEG have the potential to examine whole-brain networks that are not accessible to icEEG's necessarily limited spatial coverage. Furthermore, such a campaign of simultaneous recordings will take unprecedented advantage of icEEG as the bridge between the two noninvasive techniques, providing compelling evidence for the links between all three measurements with respect to underlying high-frequency neural activity in both health and disease. This project will therefore lead to improved selection of epilepsy surgery candidates and improved neurosurgical outcomes from the precise mapping of epileptogenic and healthy brain networks. The same techniques will be immediately applicable to functional mapping of other types of neurosurgery populations as well as diagnostic neuroimaging of neurological and psychiatric populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Healthy Volunteers
Keywords
Epilepsy surgery, High frequency activity, icEEG, fMRI, MEG

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Experimental
Arm Title
Volunteers
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MEG or fMRI And INtracranial EEG
Intervention Type
Procedure
Intervention Name(s)
fMRI
Primary Outcome Measure Information:
Title
Blood Oxygenation Level Dependent changes, associated with intracranial EEG signal, as determined by simultaneous fMRI and icEEG
Description
fMRI correlates of epileptic and cognitive-induced high-frequency activities
Time Frame
Month 2
Title
MEG signal, associated with intracranial EEG signal, as determined by simultaneous MEG and icEEG
Description
MEG correlates of epileptic and cognitive-induced high-frequency activities
Time Frame
Month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients aged between 18 and 60 years, not subject of any measure of legal protection Patients suffering from drug resistant partial epilepsy Patient undergoing intracranial video EEG Patients with electrodes implanted in orthogonal no MRI cons-indication Patients who signed a consent form Intellectual capacity to perform cognitive tasks and to sign an informed consent. Affiliation to social security Exclusion Criteria: Pregnant women Elderly patients under 18 or over 60 years Patient not suffering from drug resistant partial epilepsy, or not scheduled for a SEEG MRI cons-indication Patients taking psychotropics drugs Claustrophobia Inability to perform cognitive tasks or to give informed consent.
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69000
Country
France

12. IPD Sharing Statement

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Simultaneous MEG or fMRI And INtracranial EEG

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