Simultaneous MEG or fMRI And INtracranial EEG
SEMAINE
1 other identifier
interventional
47
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 16, 2013
CompletedFirst Submitted
Initial submission to the registry
October 6, 2014
CompletedFirst Posted
Study publicly available on registry
January 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2017
CompletedSeptember 4, 2025
August 1, 2025
3.7 years
October 6, 2014
August 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Month 2
MEG signal, associated with intracranial EEG signal, as determined by simultaneous MEG and icEEG
MEG correlates of epileptic and cognitive-induced high-frequency activities
Month 2
Study Arms (2)
Patient
EXPERIMENTALVolunteers
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospices Civils de Lyonlead
- University of Konstanzcollaborator
Study Sites (1)
Hospices Civils de Lyon
Lyon, 69000, France
Related Publications (1)
Saignavongs M, Ciumas C, Petton M, Bouet R, Boulogne S, Rheims S, Carmichael DW, Lachaux JP, Ryvlin P. Neural Activity Elicited by a Cognitive Task can be Detected in Single-Trials with Simultaneous Intracerebral EEG-fMRI Recordings. Int J Neural Syst. 2017 Feb;27(1):1750001. doi: 10.1142/S0129065717500010. Epub 2016 Aug 22.
PMID: 27718767BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2014
First Posted
January 21, 2015
Study Start
September 16, 2013
Primary Completion
May 18, 2017
Study Completion
May 18, 2017
Last Updated
September 4, 2025
Record last verified: 2025-08