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

NCT ID: NCT03066752

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-27
• Study Completion Date: 2017-11-24

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

7 pediatric-onset multiple sclerosis

No interventions assigned to this group

7 non-patient healthy volunteers

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Must be between 6 and 17 years and 11 months of age*;

2. Have a diagnosis of MS according to the revised McDonald diagnostic criteria and/or International Pediatric MS Study Group criteria;

3. Has English language knowledge at the level needed to complete clinical questionnaires (4th grade level).*

Exclusion Criteria

1. Neurological comorbidity.*;

2. Relapses or requires treatment with steroids within 30 days from enrollment;

3. Is pregnant at the time of enrollment.*;

4. Has any metal parts in their body (i.e. Cochlear (ear) implant, metal braces (dental fillings are o.k.).*;

5. Is younger than 6 years of age.*;

6. Is older than 18 years of age.*;

7. Has prior history of traumatic brain injury, neurological disorder, cerebral palsy, developmental delay or learning disability.*;

8. Requires sedation for brain scanning.*;

9. Is claustrophobic, as brain scanning requires children to enter a tunnel in the MRI machine.*

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

E. Ann Yeh

Associate Scientist, Research Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000054117

Identifier Type: -

Identifier Source: org_study_id