Determining the Extent of Diffusion Tensor Abnormalities in Focal Cortical Dysplasia
FCP
1 other identifier
observational
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 26, 2008
CompletedFirst Posted
Study publicly available on registry
May 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedSeptember 5, 2013
September 1, 2013
6.1 years
May 26, 2008
September 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Interventions
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.
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.
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.
Eligibility Criteria
Children with suspected FCD presenting with intractable epilepsy for MRI \& MEG. The children will be identified from referral for clinical MRI scans.
You may qualify if:
- Children with intractable epilepsy with suspected FCD for MRI \& MEG
You may not qualify if:
- Children with contraindications to MRI such as those with pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Raybaud, M.D.
The Hospital for Sick Children
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division Head, Neuroradiology
Study Record Dates
First Submitted
May 26, 2008
First Posted
May 30, 2008
Study Start
May 1, 2007
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
September 5, 2013
Record last verified: 2013-09