NCT00687024

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

6.1 years

First QC Date

May 26, 2008

Last Update Submit

September 4, 2013

Conditions

Keywords

EpilepsyMagnetic Resonance ImagingMagnetoencephalography

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 imagingPROCEDURE

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

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

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

Location

MeSH Terms

Conditions

Focal Cortical DysplasiaEpilepsy

Interventions

MagnetoencephalographyMagnetic Resonance SpectroscopyDiffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Malformations of Cortical Development, Group IMalformations of Cortical DevelopmentNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative TechniquesSpectrum AnalysisChemistry Techniques, AnalyticalNeuroimagingDiagnostic ImagingDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomography

Study Officials

  • Charles Raybaud, M.D.

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

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

Locations