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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Charles Raybaud, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00687024
First received: May 26, 2008
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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 Intervention
Focal Cortical Dysplasia
Epilepsy
Procedure: Magnetoencephalography
Procedure: MR imaging
Procedure: Diffusion Tensor Imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining the Extent of Diffusion Tensor Abnormalities in Focal Cortical Dysplasia

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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.

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00687024

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: Charles Raybaud, Division Head, Neuroradiology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00687024     History of Changes
Other Study ID Numbers: 1000010634
Study First Received: May 26, 2008
Last Updated: September 4, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Epilepsy
Magnetic Resonance Imaging
Magnetoencephalography

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

ClinicalTrials.gov processed this record on September 18, 2014