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Determining the Extent of Diffusion Tensor Abnormalities in Focal Cortical Dysplasia

NCT ID: NCT00687024

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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

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Focal Cortical Dysplasia Epilepsy

Keywords

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Epilepsy Magnetic Resonance Imaging Magnetoencephalography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Magnetoencephalography

MEG 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.

Intervention Type PROCEDURE

MR imaging

MR 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.

Intervention Type PROCEDURE

Diffusion Tensor Imaging

Diffusion 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children with intractable epilepsy with suspected FCD for MRI \& MEG

Exclusion Criteria

* Children with contraindications to MRI such as those with pacemaker
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Charles Raybaud

Division Head, Neuroradiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charles Raybaud, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000010634

Identifier Type: -

Identifier Source: org_study_id