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

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ClinicalTrials.gov Identifier: NCT01313260
Recruitment Status : Unknown
Verified January 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : March 11, 2011
Last Update Posted : September 28, 2012
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief 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.


Condition or disease
Epilepsies

Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Structural and Functional Connectivity in Partial Epilepsies Studied With MRI and MEG
Study Start Date : February 2011


Group/Cohort
Epilepsy patients
Epilepsy patients selected before undergoing intracranial EEG recordings
control group
Healthy volunteers



Primary Outcome Measures :
  1. Epileptic network assessed using structural and functional connectivity measures obtained with MRI and MEG [ Time Frame: one year ]

    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.




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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Refractory partial epilepsy patients
Criteria

Inclusion Criteria:

  • intracranial EEG recordings scheduled
  • no neurological or psychiatric disease for healthy volunteers

Exclusion Criteria:

  • contraindication to MRI
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313260


Contacts
Contact: Lionel Thivard, MD, PhD 33 1 57 27 43 64 lionel.thivard@psl.aphp.fr

Locations
France
ICM (Brain and Spine Institute) Recruiting
Paris, France, 75013
Contact: Lionel Thivard, MD, PhD    33 1 57 27 43 64    lionel.thivard@psl.aphp.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

Additional Information:
Publications:
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01313260     History of Changes
Other Study ID Numbers: C09-21
2010-A00399-30 ( Registry Identifier: IDRCB )
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: September 28, 2012
Last Verified: January 2012

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Refractory partial epilepsies

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases