Structural and Functional Connectivity in Partial Epilepsies Studied With MRI and MEG

Epilepsies Clinical Trial

Official title:

Structural and Functional Connectivity in Partial Epilepsies Studied With MRI and MEG

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01313260
• Other study ID #: C09-21
• Secondary ID: 2010-A00399-30
• Status: Recruiting
• Phase: N/A
• First received: February 15, 2011
• Last updated: September 27, 2012
• Start date: February 2011

Study information

• Verified date: January 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Lionel Thivard, MD, PhD
• Phone: 33 1 57 27 43 64
• Email: lionel.thivard[@]psl.aphp.fr
• Is FDA regulated: No
• Health authority: France: French AFSSAPS (French Health Products Safety Agency)
• Study type: Observational

Clinical Trial Summary

Surgery may be an effective therapy for refractory focal epilepsies with a clear delineated focus but surgical benefits are less clear for patients with a poorly defined focus such as non lesional refractory partial epilepsies.

SEEG is considered the criterion standard to localize the epileptogenic zone (EZ) but the procedure is risky with a limited spatial sampling. The development of non-invasive neuroimaging alternatives is thus an important goal to improve EZ delineation and optimize SEEG procedures.

The main hypothesis of this research project is the existence of a network organization specific for each patient which allows the generation and propagation of epileptic activities. The investigators wish to explore this network using diffusion tensor MRI to study structural connectivity and MEG/FMRI to study functional connectivity. The investigators will apply tools from the theories of complex networks and dynamical systems to characterize the network organization of epileptic process.

The investigators aimed to identify and localize differences in connectivity parameters between individual patients and a control group of healthy volunteers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• intracranial EEG recordings scheduled

• no neurological or psychiatric disease for healthy volunteers

Exclusion Criteria:

• contraindication to MRI

• pregnancy

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsies
• Epilepsies, Partial
• Epilepsy

Locations

Country	Name	City	State
France	ICM (Brain and Spine Institute)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Chavez M, Valencia M, Navarro V, Latora V, Martinerie J. Functional modularity of background activities in normal and epileptic brain networks. Phys Rev Lett. 2010 Mar 19;104(11):118701. Epub 2010 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epileptic network assessed using structural and functional connectivity measures obtained with MRI and MEG	Structural connectivity will be assessed using diffusion tensor MRI including the following parameters: mean diffusivity and anisotropy at voxel level, fiber tractography.; Functional connectivity will be assessed using Rs-FMRI or MEG signal correlation measures. Cortical parcellation will allow the location of connectivity parameters calculated using the graph theory.; Structural and functional data from one given patient will be statistically compared those of the control group.	one year	No

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