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

NCT03066752 | Completed

• 1 other identifier: 1000054117
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Multiple Sclerosis

Outcome Measures

Primary Outcomes (5)

• Neuronal responses during simple and choice reaction time tasks

  Video-based eye tracking in the MEG

  60 minutes

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

  90 minutes

• Neurocognitive Testing

  Penn Computerized Neurocognitive Battery

  90 minutes

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

  20 minutes

• Clinical Interview

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

  10 minutes

Study Arms (2)

7 pediatric-onset multiple sclerosis

7 non-patient healthy volunteers

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Seven patients who have pediatric-onset multiple sclerosis and 7 healthy (non-patient) children are expected to participate in this study.

You may qualify if:

• 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).\*

You may not qualify if:

• 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.\*

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

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: February 28, 2017
• Study Start: March 27, 2017
• Primary Completion: November 24, 2017
• Study Completion: November 24, 2017
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)