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

January 6, 2020 updated by: E. Ann Yeh, The Hospital for Sick 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
        • Queen's University
      • Toronto, Ontario, Canada, M5G1X8
        • Hospital For Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
40 Demyelinating Disease patients
40 Non-patient participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 minutes
Electrical potentials initiated by brief visual stimuli
Time Frame: 10 minutes
Visual Evoked Potentials (VEP)
10 minutes
MRI scans of the brain, including Diffusion Tensor Imagine (DTI)
Time Frame: 90 minutes
90 minutes
Neurocognitive Testing
Time Frame: 90 minutes
Computerized Penn Neurocognitive Battery
90 minutes
High contrast visual acuity
Time Frame: 10 minutes
10 minutes
Low contrast visual acuity; colour vision; visual fields testing; OCT testing;
Time Frame: 10 minutes
10 minutes
Colour vision testing
Time Frame: 10 minutes
10 minutes
Visual fields testing
Time Frame: 20 minutes
20 minutes
Optical coherence tomography (OCT)
Time Frame: 25 minutes
25 minutes
Neurological Exam - Standard physical exam performed by neurologist to determine the Expanded Disability Status Scale (EDSS) score.
Time Frame: 20 minutes
20 minutes
Clinical Interview
Time Frame: 10 minutes
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

November 16, 2018

Study Completion (Actual)

November 16, 2018

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000053920

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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