Clinical trial NCT03010826: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Demyelinating Disease
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 78
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: There will be a total of 80 participants in this study. The study population consists of both patients (demyelinating disease) and non-patient participants (healthy volunteers).

Brief summary: The neural circuits in our brains require a layer of insulation in order to transmit signals in a rapid and efficient fashion. This insulation is called White Matter and is comprised of a specific type of brain cell called an oligodendrocytes. Damage to brain white matter occurs following injury and in disorders like Multiple Sclerosis and results in sensory, motor, and cognitive problems. Currently there are no effective medical therapies to promote brain repair and reduce disability following damage to white matter. In this project, we hope to change the situation by encouraging the brain itself to generate new oligodendrocytes and thus new white matter. Our first step is to find measures sensitive to white matter growth.


Eligibility criteria: 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

Primary outcomes:
measure: Neuronal responses during pro/anti-saccade eye movements
timeFrame: 60 minutes
measure: Electrical potentials initiated by brief visual stimuli
timeFrame: 10 minutes
measure: MRI scans of the brain, including Diffusion Tensor Imagine (DTI)
timeFrame: 90 minutes
measure: Neurocognitive Testing
timeFrame: 90 minutes
measure: High contrast visual acuity
timeFrame: 10 minutes
measure: Low contrast visual acuity; colour vision; visual fields testing; OCT testing;
timeFrame: 10 minutes
measure: Colour vision testing
timeFrame: 10 minutes
measure: Visual fields testing
timeFrame: 20 minutes
measure: Optical coherence tomography (OCT)
timeFrame: 25 minutes
measure: Neurological Exam - Standard physical exam performed by neurologist to determine the Expanded Disability Status Scale (EDSS) score.
timeFrame: 20 minutes
measure: Clinical Interview
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
References: