NCT01313260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
25 days until next milestone

Study Start

First participant enrolled

April 5, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

2.5 years

First QC Date

February 15, 2011

Last Update Submit

January 21, 2025

Conditions

Keywords

Refractory partial epilepsies

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Epilepsy patients

Epilepsy patients selected before undergoing intracranial EEG recordings

control group

Healthy volunteers

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Refractory partial epilepsy patients

You may qualify if:

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

You may not qualify if:

  • contraindication to MRI
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICM (Brain and Spine Institute)

Paris, 75013, France

Location

Related 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. doi: 10.1103/PhysRevLett.104.118701. Epub 2010 Mar 18.

    PMID: 20366507BACKGROUND

Related Links

MeSH Terms

Conditions

EpilepsyEpilepsies, Partial

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2011

First Posted

March 11, 2011

Study Start

April 5, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 23, 2025

Record last verified: 2025-01

Locations