Improving Lesion Detection in Children With Magnetic Resonance Imaging (MRI)-Negative Partial Epilepsy Using Diffusion Tensor Imaging

NCT00894478 | Completed

• 1 other identifier: 1000013137
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Focal cortical dysplasia is one of the most common lesions responsible for medically refractory epilepsy in the pediatric population. In patients with medically intractable epilepsy, surgery is the only treatment that will lead to seizure freedom. The outcome of epilepsy surgery is worse in patients when there is no lesion identified on routine structural MRI, also known as MRI-negative partial epilepsy. Diffusion tensor imaging (DTI), a novel MRI technique, can be used to evaluate the integrity of the microstructure of the white matter, even when the white matter appears normal on routine MRI.

Conditions

Localization-related Epilepsy; Partial Epilepsy

Keywords

MRI-Negative; Diffusion tensor imaging; Localization-related epilepsy; Partial Epilepsy; Children

Outcome Measures

Primary Outcomes (1)

• Identify DTI changes in the white matter of children with MRI-negative partial epilepsy and MRI-visible FCD using voxel-by-voxel analysis of FA and MD maps compared to normal controls.

  1 timepoint; immediately after MRI/DTI

Secondary Outcomes (1)

• Determine if the lobar location of abnormal FA and MD correlate with the lobar location of MEG defined epileptogenic zone in MRI-negative partial epilepsy and MRI-visible FCD.

  1 timepoint; immediately after MRI/DTI

Study Arms (3)

1

12 children with MRI-negative partial epilepsy who are being worked-up for epilepsy surgery

Procedure: Diffusion Tensor Imaging (DTI); Procedure: Magnetoencephalography

2

12 children with MRI-visible FCD who are being worked-up for epilepsy surgery

Procedure: Diffusion Tensor Imaging (DTI); Procedure: Magnetoencephalography

3

Control Group- Healthy Volunteers

Procedure: Diffusion Tensor Imaging (DTI)

Interventions

Diffusion Tensor Imaging (DTI) PROCEDURE

MR and DTI: MRI and DTI will be done using 3.0T Philips MR scanner (Philips Medical Systems, Best, The Netherlands) using an eight channel head coil. DTI and axial 3D T1 will be performed on patients and controls. 1. DTI will be performed using single shot diffusion-weighted echo planar imaging, b=1000s/mm2 and 15 noncollinear directions (TR/TE=10,000/60 ms, slice thickness=2mm, field of view=22cm, matrix=112x112, NEX=2) 2. Axial 3D T1 (TR/TE=4.9/2.3 ms, slice thickness=1 mm, field of view = 24 cm, matrix=220x220, NEX=1) Patients will have additional sequences (axial and coronal T2, proton density and FLAIR) as part of their clinical scan

1; 2; 3

Magnetoencephalography PROCEDURE

MEG will be performed using a whole-head Omega 151-channel gradiometer system (VSM MedTech, Port Coquitalam, BC, Canada). At least 15 2-minute periods of spontaneous data will be recorded with a sampling rate for data acquisition of 625Hz, a bandpass filter of 10 to 70 Hz and a notch filter of 60 Hz.

Also known as: MEG

1; 2

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified from the epilepsy clinic and seizure rounds and who have had previous MRI in an outside institution or prior MRI at least two years ago at the Hospital for Sick Children. Control children will be recruited through hospital publications and from families participating in the study (healthy siblings)

You may qualify if:

• MRI negative partial epilepsy group:
• Patients diagnosed with partial epilepsy according to the International League Against Epilepsy (ILAE) standard \[53\]
• MRI study reported as normal
• Age ranging from 6-18 years (DTI indices alter with myelination and the changes are most marked from birth to 4 years of age)
• MRI-visible FCD group:
• Patients diagnosed with partial epilepsy according to the ILAE standard \[53\]
• Visual assessment of MRI demonstrates one or more features of FCD
• Cortical thickening
• Alteration in sulci and gyri pattern, including deep sulci
• Blurring of gray-white matter transition
• T2 signal prolongation of the cortex and subcortical white matter
• High T1 signal in the cortex
• Age ranging from 6-18 years (DTI indices alter with myelination and the changes are most marked from birth to 4 years of age)
• Normal controls:
• Subjects with no history of neurological diseases

You may not qualify if:

• Subjects with contraindications for MR imaging (i.e. retained foreign bodies, implants)
• Subjects with claustrophobia
• Controls with a prior history of traumatic brain injury, neurological disorder, cerebral palsy, developmental delay or learning disability
• Controls who require general anesthesia or sedation

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Diffusion Tensor Imaging; Magnetoencephalography

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques; Electrodiagnosis; Magnetometry

Study Officials

• Elysa Widjaja, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Neuroradiologist

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 7, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 10, 2013

Record last verified: 2013-09

Locations

CA (1)