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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 16, 2018

Arms, Groups and Cohorts

  • 40 Demyelinating Disease patients
  • 40 Non-patient participants

Clinical Trial Outcome Measures

Primary Measures

  • Neuronal responses during pro/anti-saccade eye movements
    • Time Frame: 60 minutes
    • Video-based eye tracking monocularly in the MEG and binocularly outside the MEG
  • Electrical potentials initiated by brief visual stimuli
    • Time Frame: 10 minutes
    • Visual Evoked Potentials (VEP)
  • MRI scans of the brain, including Diffusion Tensor Imagine (DTI)
    • Time Frame: 90 minutes
  • Neurocognitive Testing
    • Time Frame: 90 minutes
    • Computerized Penn Neurocognitive Battery
  • High contrast visual acuity
    • Time Frame: 10 minutes
  • Low contrast visual acuity; colour vision; visual fields testing; OCT testing;
    • Time Frame: 10 minutes
  • Colour vision testing
    • Time Frame: 10 minutes
  • Visual fields testing
    • Time Frame: 20 minutes
  • Optical coherence tomography (OCT)
    • Time Frame: 25 minutes
  • Neurological Exam – Standard physical exam performed by neurologist to determine the Expanded Disability Status Scale (EDSS) score.
    • Time Frame: 20 minutes
  • Clinical Interview
    • Time Frame: 10 minutes

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The Hospital for Sick Children
  • Provider of Information About this Clinical Study
    • Principal Investigator: E. Ann Yeh, Associate Scientist, Research Institute – The Hospital for Sick Children

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