- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00894478
Improving Lesion Detection in Children With Magnetic Resonance Imaging (MRI)-Negative Partial Epilepsy Using Diffusion Tensor Imaging
Improving Lesion Detection in Children With MRI-negative Partial Epilepsy Using Diffusion Tensor Imaging
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- The Hospital for Sick Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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)
Description
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]
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
12 children with MRI-negative partial epilepsy who are being worked-up for epilepsy surgery
|
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 Names:
|
2
12 children with MRI-visible FCD who are being worked-up for epilepsy surgery
|
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 Names:
|
3
Control Group- Healthy Volunteers
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 timepoint; immediately after MRI/DTI
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 timepoint; immediately after MRI/DTI
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elysa Widjaja, MD, The Hospital for Sick Children
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000013137
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Partial Epilepsy
-
SK Life Science, Inc.CompletedEpilepsy, Complex Partial | Epilepsy, Partial, Motor | Epilepsy, Simple Partial | Focal Motor Epilepsy
-
SK Life Science, Inc.CompletedEpilepsy, Complex Partial | Epilepsy, Partial, Motor | Epilepsy, Simple Partial | Focal Motor Epilepsy
-
Bial - Portela C S.A.CompletedEfficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial SeizuresRefractory Partial EpilepsyPortugal
-
University Hospital, LilleUnknownFocal Epilepsy | Epilepsy IntractableFrance
-
Northeast Regional Epilepsy GroupPfizerTerminatedEpilepsy, Complex PartialUnited States
-
Bial - Portela C S.A.CompletedPartial Epilepsy in Children and AdolescentsUnited Kingdom, Spain, Serbia, Italy, Austria, Bosnia and Herzegovina, Croatia, Czechia, France, Germany, Hungary, Malaysia, Moldova, Republic of, Philippines, Poland, Portugal, Romania, Russian Federation, Slovakia, Taiwan, Ukr...
-
Hospices Civils de LyonCompletedDrug-resistant Partial EpilepsyFrance
-
Emory UniversityPatient-Centered Outcomes Research InstituteTerminatedEpilepsy, Partial | Epilepsy, Localization RelatedUnited States
-
Atlantic UniversityA.T. Still University of Health SciencesCompletedPartial Epilepsy | Focal Onset EpilepsyUnited States
-
Xuanwu Hospital, BeijingPeking University; Beijing Tiantan Hospital; Qilu Hospital of Shandong University and other collaboratorsNot yet recruitingEpilepsy, Drug ResistantChina
Clinical Trials on Diffusion Tensor Imaging (DTI)
-
CCTU- Cancer ThemeCambridge University Hospitals NHS Foundation Trust; Cancer Research UK; Experimental...Active, not recruitingHigh Grade GliomaUnited Kingdom
-
Second Affiliated Hospital, School of Medicine,...RecruitingANCA Associated VasculitisChina
-
Washington University School of MedicineCompletedUterine Cervical NeoplasmsUnited States
-
University of Michigan Rogel Cancer CenterTerminated
-
University of MichiganWithdrawn
-
Swiss Paraplegic Research, NottwilCompletedParalysis | Functional Neurological Symptom Disorder | Conversion Disorder With Weakness/ParalysisSwitzerland
-
Assistance Publique - Hôpitaux de ParisCompletedCervical SpondylosisFrance
-
TC Erciyes UniversityThe Scientific and Technological Research Council of TurkeyUnknownWound, Healed (Morphologic Abnormality) | Injury of Median NerveTurkey