Cognitive Dysfunction in MS: Using Altered Brain Oscillation to Link Molecular Mechanisms With Clinical Outcomes

Up to 65% of patients with multiple sclerosis (MS) experience cognitive dysfunction. Diminution of mental capacity has a pervasive and profound impact on their quality of life. Subtle changes in white matter predict cognitive changes in these patients but how this disrupts brain function remains unclear. Development of effective therapeutics to restore normal cognition hinges on elucidating these functional changes. The investigators seek to uncover the patho-physiological basis for cognitive decline in MS. The investigators hypothesize that cognitive decline originates from disrupted gamma oscillations and that gamma oscillations are disrupted by molecular changes triggered by demyelination.

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Key information

Conditions

Pediatric Multiple Sclerosis

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

(*applicable to controls):

Must be between 6 and 17 years and 11 months of age*;
Have a diagnosis of MS according to the revised McDonald diagnostic criteria and/or International Pediatric MS Study Group criteria;
Has English language knowledge at the level needed to complete clinical questionnaires (4th grade level).*

Exclusion criteria

(*applicable to controls):

Neurological comorbidity.*;
Relapses or requires treatment with steroids within 30 days from enrollment;
Is pregnant at the time of enrollment.*;
Has any metal parts in their body (i.e. Cochlear (ear) implant, metal braces (dental fillings are o.k.).*;
Is younger than 6 years of age.*;
Is older than 18 years of age.*;
Has 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

Neuronal responses during simple and choice reaction time tasks

Time frame: 60 minutes

Video-based eye tracking in the MEG
MRI scans of the brain, including Diffusion Tensor Imagine (DTI)

Time frame: 90 minutes
Neurocognitive Testing

Time frame: 90 minutes

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

Time frame: 20 minutes
Clinical Interview

Time frame: 10 minutes

Series of questions about the participant's demographic and clinical information including, current and past health, family history, and medications.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Feb 28, 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.

Published trials that share one or more normalized conditions with this study.

Completed