Clinical trial NCT03066752: Cognitive Dysfunction in MS: Using Altered Brain Oscillation to Link Molecular Mechanisms With Clinical Outcomes
Official title: Cognitive Dysfunction in MS: Using Altered Brain Oscillation to Link Molecular Mechanisms With Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Multiple Sclerosis
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.\*

Primary outcomes:
measure: Neuronal responses during simple and choice reaction time tasks
timeFrame: 60 minutes
measure: MRI scans of the brain, including Diffusion Tensor Imagine (DTI)
timeFrame: 90 minutes
measure: Neurocognitive Testing
timeFrame: 90 minutes
measure: Neurological Exam - Standard physical exam performed by the neurologist to determine the Expanded Disability Status Scale (EDSS) score.
timeFrame: 20 minutes
measure: Clinical Interview
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
References: