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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03066752
Enrollment
20
Registered
2017-02-28
Start date
2017-03-27
Completion date
2017-11-24
Last updated
2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Multiple Sclerosis

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.

Interventions

None listed

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

(\*applicable to controls): 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

(\*applicable to controls): 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.\*

Design outcomes

Primary

MeasureTime frameDescription
Neuronal responses during simple and choice reaction time tasks60 minutesVideo-based eye tracking in the MEG
MRI scans of the brain, including Diffusion Tensor Imagine (DTI)90 minutes
Neurocognitive Testing90 minutesPenn Computerized Neurocognitive Battery
Neurological Exam - Standard physical exam performed by the neurologist to determine the Expanded Disability Status Scale (EDSS) score.20 minutes
Clinical Interview10 minutesSeries of questions about the participant's demographic and clinical information including, current and past health, family history, and medications.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026