Improving Lesion Detection in Children With Magnetic Resonance Imaging (MRI)-Negative Partial Epilepsy Using Diffusion Tensor Imaging
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ClinicalTrials.gov Identifier: NCT00894478 |
Recruitment Status
:
Completed
First Posted
: May 7, 2009
Last Update Posted
: September 10, 2013
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Condition or disease | Intervention/treatment |
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Localization-related Epilepsy Partial Epilepsy | Procedure: Diffusion Tensor Imaging (DTI) Procedure: Magnetoencephalography |
Study Type : | Observational |
Actual Enrollment : | 64 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Improving Lesion Detection in Children With MRI-negative Partial Epilepsy Using Diffusion Tensor Imaging |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Group/Cohort | Intervention/treatment |
---|---|
1
12 children with MRI-negative partial epilepsy who are being worked-up for epilepsy surgery
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Procedure: Diffusion Tensor Imaging (DTI)
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.
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.
Other Name: MEG
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2
12 children with MRI-visible FCD who are being worked-up for epilepsy surgery
|
Procedure: Diffusion Tensor Imaging (DTI)
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.
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.
Other Name: MEG
|
3
Control Group- Healthy Volunteers
|
Procedure: Diffusion Tensor Imaging (DTI)
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.
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- 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. [ Time Frame: 1 timepoint; immediately after MRI/DTI ]
- 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. [ Time Frame: 1 timepoint; immediately after MRI/DTI ]

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Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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)
Inclusion Criteria:
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]
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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
- Age ranging from 6-18 years (most children under the age of 6 years are unable to tolerate the MR examination without general anesthesia or sedation).
- No requirement of general anesthesia or sedation
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894478
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada |
Principal Investigator: | Elysa Widjaja, MD | The Hospital for Sick Children |
Responsible Party: | Elysa Widjaja, Staff Neuroradiologist, The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00894478 History of Changes |
Other Study ID Numbers: |
1000013137 |
First Posted: | May 7, 2009 Key Record Dates |
Last Update Posted: | September 10, 2013 |
Last Verified: | September 2013 |
Keywords provided by Elysa Widjaja, The Hospital for Sick Children:
MRI-Negative Diffusion tensor imaging Localization-related epilepsy Partial Epilepsy Children |
Additional relevant MeSH terms:
Epilepsy Epilepsies, Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases |