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CompletedNCT00687024FCPUpdated Sep 5, 2013

Determining the Extent of Diffusion Tensor Abnormalities in Focal Cortical Dysplasia

An observational study in Focal Cortical Dysplasia and Epilepsy, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2013-09-05.

Sponsored by The Hospital for Sick Children · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
Up to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Focal Cortical Dysplasia
  • Epilepsy

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Keywords

  • Epilepsy
  • Magnetic Resonance Imaging
  • Magnetoencephalography
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In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 12 is below the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
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

Exclusion Criteria:

  • Children with contraindications to MRI such as those with pacemaker
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)

Interventions

  • ProcedureMagnetoencephalography

    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.

  • ProcedureMR 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.

  • ProcedureDiffusion 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.

06

What researchers measure

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

    Time frame: Immediately after MEG

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Study locations

1 site
  • The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00687024
Lead sponsor
The Hospital for Sick Children
Responsible party
Charles Raybaud (Division Head, Neuroradiology, The Hospital for Sick Children) — Principal investigator
First posted
May 30, 2008
Start date
May 2007
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Sep 5, 2013

Study contacts

Charles Raybaud, M.D.
principal investigator · The Hospital for Sick Children

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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