Simultaneous MEG or fMRI And INtracranial EEG

Healthy Volunteers Clinical Trial

— SEMAINE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342938
• Other study ID #: 2011.698
• Status: Completed
• Phase: N/A
• First received: October 6, 2014
• Last updated: February 1, 2018
• Start date: September 16, 2013
• Est. completion date: May 18, 2017

Study information

• Verified date: February 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 18, 2017
• Est. primary completion date: May 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Healthy Volunteers

Intervention

Procedure:
• MEG or fMRI And INtracranial EEG

• fMRI

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	University of Konstanz

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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