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

NCT03010826 | Completed

• 1 other identifier: 1000053920
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Demyelinating Disease

Outcome Measures

Primary Outcomes (11)

• Neuronal responses during pro/anti-saccade eye movements

  Video-based eye tracking monocularly in the MEG and binocularly outside the MEG

  60 minutes

• Electrical potentials initiated by brief visual stimuli

  Visual Evoked Potentials (VEP)

  10 minutes

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

  90 minutes

• Neurocognitive Testing

  Computerized Penn Neurocognitive Battery

  90 minutes

• High contrast visual acuity

  10 minutes

• Low contrast visual acuity; colour vision; visual fields testing; OCT testing;

  10 minutes

• Colour vision testing

  10 minutes

• Visual fields testing

  20 minutes

• Optical coherence tomography (OCT)

  25 minutes

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

  20 minutes

• Clinical Interview

  10 minutes

Study Arms (2)

40 Demyelinating Disease patients

40 Non-patient participants

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (2)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Demyelinating Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist, Research Institute

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 5, 2017
• Study Start: December 1, 2016
• Primary Completion: November 16, 2018
• Study Completion: November 16, 2018
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

CA (2)