NCT02342938

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2017

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

3.7 years

First QC Date

October 6, 2014

Last Update Submit

August 27, 2025

Conditions

Keywords

Epilepsy surgeryHigh frequency activityicEEGfMRIMEG

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

EXPERIMENTAL
Procedure: fMRI

Volunteers

EXPERIMENTAL
Procedure: MEG or fMRI And INtracranial EEG

Interventions

fMRIPROCEDURE
Patient

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69000, France

Location

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

Epilepsy

Interventions

Magnetoencephalography

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative Techniques

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

Locations