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Completed

NCT Number: NCT02342938

Simultaneous MEG or fMRI And INtracranial EEG

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Lyon, 69000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MEG or fMRI And INtracranial EEG

Procedure

fMRI

Procedure

Primary outcomes

  1. Blood Oxygenation Level Dependent changes, associated with intracranial EEG signal, as determined by simultaneous fMRI and icEEG

    Time frame: Month 2

    fMRI correlates of epileptic and cognitive-induced high-frequency activities

  2. MEG signal, associated with intracranial EEG signal, as determined by simultaneous MEG and icEEG

    Time frame: Month 2

    MEG correlates of epileptic and cognitive-induced high-frequency activities

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • University of Konstanz

Registry information

Acronym: SEMAINE

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 21, 2015
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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