Clinical Trials Directory

Trials / Completed

CompletedNCT00687024

Determining the Extent of Diffusion Tensor Abnormalities in Focal Cortical Dysplasia

Status
Completed
Phase
Study type
Observational
Enrollment
12 (actual)
Sponsor
The Hospital for Sick Children · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREMagnetoencephalographyMEG will be performed on a whole head Omega 151-channel gradiometer system. At least 15 2-minute periods of spontaneous data are recorded. The sampling rate for data acquisition is 625Hz, with a bandpass filter of 3 to 70 Hz and a notch filter of 60Hz.
PROCEDUREMR imagingMR imaging will be performed on a GE 1.5T system using a variety of sequences, including sagittal T1, axial T2, axial FLAIR, coronal dual echo, coronal FLAIR, axial 3D T2 frFSE and axial SPGR.
PROCEDUREDiffusion Tensor ImagingDiffusion tensor imaging will be performed on the same scanner, using single shot diffusion-weighted echo planar imaging. Twenty-five 'xial contiguous slices are obtained aligned to the anterior commissure line to cover the whole brain, giving a total imaging time of 4min 40sec.

Timeline

Start date
2007-05-01
Primary completion
2013-06-01
Completion
2013-06-01
First posted
2008-05-30
Last updated
2013-09-05

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00687024. Inclusion in this directory is not an endorsement.