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

Demyelinating Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010826
• Other study ID #: 1000053920
• Status: Completed
• Start date: December 2016
• Est. completion date: November 16, 2018

Study information

• Verified date: January 2020
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 16, 2018
• Est. primary completion date: November 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Demyelinating Disease
• Demyelinating Diseases

Locations

Country	Name	City	State
Canada	Queen`s University	Kingston	Ontario
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

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