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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00687024
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : September 5, 2013
Information provided by (Responsible Party):
Charles Raybaud, The Hospital for Sick Children

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
Focal Cortical Dysplasia Epilepsy 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 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 2007
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Intervention Details:
    Procedure: 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.
    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.
    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.

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 [ Time Frame: Immediately after MEG ]

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with suspected FCD presenting with intractable epilepsy for MRI & MEG. The children will be identified from referral for clinical MRI scans.

Inclusion Criteria:

  • Children with intractable epilepsy with suspected FCD for MRI & MEG

Exclusion Criteria:

  • Children with contraindications to MRI such as those with pacemaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00687024

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Charles Raybaud, M.D. The Hospital for Sick Children

Responsible Party: Charles Raybaud, Division Head, Neuroradiology, The Hospital for Sick Children Identifier: NCT00687024     History of Changes
Other Study ID Numbers: 1000010634
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Keywords provided by Charles Raybaud, The Hospital for Sick Children:
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Malformations of Cortical Development
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nervous System Malformations
Congenital Abnormalities