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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01313260
First received: February 15, 2011
Last updated: September 27, 2012
Last verified: January 2012
  Purpose

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
Epilepsies

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Structural and Functional Connectivity in Partial Epilepsies Studied With MRI and MEG

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Epileptic network assessed using structural and functional connectivity measures obtained with MRI and MEG [ Time Frame: one year ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 45
Study Start Date: February 2011
Groups/Cohorts
Epilepsy patients
Epilepsy patients selected before undergoing intracranial EEG recordings
control group
Healthy volunteers

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: February 15, 2011
Last Updated: September 27, 2012
Health Authority: France: French AFSSAPS (French Health Products Safety Agency)

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

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

ClinicalTrials.gov processed this record on November 19, 2014