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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03010826 |
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Date of registration:
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03/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacological Recruitment of Endogenous Neural Precursors to Promote Pediatric White Matter Repair: Establishing Correlations Between Visual Outcomes, Saccadic Function and MEG Oscillations in Children With Demyelinating Disorders in Comparison to Healthy Control Children
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Scientific title:
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Pharmacological Recruitment of Endogenous Neural Precursors to Promote Pediatric White Matter Repair: Establishing Correlations Between Visual Outcomes, Saccadic Function and MEG Oscillations in Children With Demyelinating Disorders in Comparison to Healthy Control Children |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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78 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03010826 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Experienced a demyelinating event (Only applicable to patient subjects)
- Between the ages of 5 years to 18 years and 11 months of age
- Has either English as his or her native language or has had at least two years of
schooling in English
Exclusion Criteria:
- Children with non-demyelinating etiologies of white matter dysfunction (i.e.,
metabolic disorders, vasculitis, and non-specific MRI abnormalities
- Is younger than 5 years of age
- Is 18 years and 11 of age or older
- Has a prior history of traumatic brain injury, neurological disorder, cerebral palsy,
developmental delay, or learning disability
- Requires sedation for brain scanning
- Is claustrophobic, as brain scanning requires children to enter a tunnel in the MRI
machine
Age minimum:
5 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Demyelinating Disease
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Primary Outcome(s)
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Optical coherence tomography (OCT)
[Time Frame: 25 minutes]
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Neuronal responses during pro/anti-saccade eye movements
[Time Frame: 60 minutes]
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Colour vision testing
[Time Frame: 10 minutes]
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Low contrast visual acuity; colour vision; visual fields testing; OCT testing;
[Time Frame: 10 minutes]
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MRI scans of the brain, including Diffusion Tensor Imagine (DTI)
[Time Frame: 90 minutes]
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Neurocognitive Testing
[Time Frame: 90 minutes]
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Electrical potentials initiated by brief visual stimuli
[Time Frame: 10 minutes]
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High contrast visual acuity
[Time Frame: 10 minutes]
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Neurological Exam - Standard physical exam performed by neurologist to determine the Expanded Disability Status Scale (EDSS) score.
[Time Frame: 20 minutes]
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Clinical Interview
[Time Frame: 10 minutes]
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Visual fields testing
[Time Frame: 20 minutes]
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Secondary ID(s)
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1000053920
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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