FCP: Determining the Extent of Diffusion Tensor Abnormalities in Focal Cortical Dysplasia

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Completed
CT.gov ID
NCT00687024
Collaborator
(none)
12
1
73
0.2

Study Details

Study Description

Brief Summary

Focal cortical dysplasia (FCD) is a common finding in epilepsy surgery in pediatric patients. Children with intractable epilepsy would have extensive tests to identify the cause of epilepsy; this includes MR brain, video EEG and magnetoencephalography (MEG). The white matter next to FCD is frequently found to be abnormal on pathology. Diffusion tensor imaging (DTI) can be used to study the abnormal white matter and the area that often extends beyond the area that is visible.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Magnetoencephalography
  • Procedure: MR imaging
  • Procedure: Diffusion Tensor Imaging

Detailed Description

Focal cortical dysplasia (FCD) is a highly epileptogenic form of malformation of cortical development that may require surgical resection for epilepsy control. With abnormal development and organization of neurons within the cortex, the white matter projecting from the abnormal cortex is likely to be abnormal as well. The abnormality in the white matter involves not only the subcortical white matter, but also the long tracts in the deep white matter associated with the dysplastic cortex. Histologically, the subcortical white matter adjacent to the dysplastic cortex has been found to be abnormal. Studies using diffusion tensor imaging (DTI) to investigate the white matter adjacent to the MR visible abnormality have demonstrated reduced fractional anisotropy. However, electrographic abnormality in FCD often extends beyond the visible MR abnormality and surgical outcome of epilepsy surgery in FCD is dependent on excising the MR visible abnormality as well as electrographically abnormal area beyond the MR visible abnormality. The cortical and white matter abnormalities are therefore assumed to extend beyond the MR visible lesion. The short-term goal of this study is to determine whether quantitative measures of the abnormal white matter using DTI are able to provide surrogate markers for the extent of FCD. Whilst surgical outcome data is not available for the purpose of this study, these children will be followed up and in the longer term, the extent of FCD as determined by DTI will be compared with clinical outcome post surgery. This study will help determine the potential value of this technique in identifying areas of FCD that appear normal on structural MR. In the long term, this technique can be extended to study children with intractable epilepsy with (i) MR occult lesion and (ii) developmental tumor with MR occult FCD adjacent to the tumor.

Study Design

Study Type:
Observational
Actual Enrollment :
12 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Determining the Extent of Diffusion Tensor Abnormalities in Focal Cortical Dysplasia
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Outcome Measures

Primary Outcome Measures

  1. Evaluate the subcortical white matter in the visualized MR abnormality as well as beyond the visualized MR abnormality but subjacent to the MEG dipoles [Immediately after MEG]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Children with intractable epilepsy with suspected FCD for MRI & MEG
Exclusion Criteria:
  • Children with contraindications to MRI such as those with pacemaker

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8

Sponsors and Collaborators

  • The Hospital for Sick Children

Investigators

  • Principal Investigator: Charles Raybaud, M.D., The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Charles Raybaud, Division Head, Neuroradiology, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00687024
Other Study ID Numbers:
  • 1000010634
First Posted:
May 30, 2008
Last Update Posted:
Sep 5, 2013
Last Verified:
Sep 1, 2013
Keywords provided by Charles Raybaud, Division Head, Neuroradiology, The Hospital for Sick Children
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2013