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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Demyelinating Disease Demyelinating Diseases Nervous System Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen's University, Kingston, Ontario, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Electrical potentials initiated by brief visual stimuli

    Time frame: 10 minutes

    Visual Evoked Potentials (VEP)

  3. MRI scans of the brain, including Diffusion Tensor Imagine (DTI)

    Time frame: 90 minutes

  4. Neurocognitive Testing

    Time frame: 90 minutes

    Computerized Penn Neurocognitive Battery

  5. High contrast visual acuity

    Time frame: 10 minutes

  6. Low contrast visual acuity; colour vision; visual fields testing; OCT testing;

    Time frame: 10 minutes

  7. Colour vision testing

    Time frame: 10 minutes

  8. Visual fields testing

    Time frame: 20 minutes

  9. Optical coherence tomography (OCT)

    Time frame: 25 minutes

  10. Neurological Exam - Standard physical exam performed by neurologist to determine the Expanded Disability Status Scale (EDSS) score.

    Time frame: 20 minutes

  11. Clinical Interview

    Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2017
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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