Optimizing Detection and Prediction of Changes in Cognitive Function in Multiple Sclerosis (MS)

Study Overview
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Brief Summary
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The researchers will use technology-assisted ambulatory assessment techniques to examine cognitive dysfunction in people with Multiple Sclerosis (MS). The researchers will determine if ambulatory assessments are sensitive to subtle declines in cognitive functioning. They will also explore the impact of modifiable factors, such as sleep, physical activity, mood, and somatic symptoms on cognitive function. These efforts will uncover behavioral and medical intervention methods. Finally, they will explore whether variability in cognitive functioning predicts short- and long-term changes in other patient-centered functional domains, social participation and physical functioning.

Official Title
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Optimizing Detection and Prediction of Changes in Cognitive Function in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are able to fluently converse and read in English. Multiple Sclerosis (MS) diagnosis (confirmed from neurologist, all relapsing and progressive subtypes included) Ambulate either independently or with the use of a cane or walker (or similar device) for at least 50% of the time at baseline Exclusion Criteria: MS relapse within the past 30 days (may become eligible after 30 days; criteria used at T1, T2, and T3). Inability to use study data collection tools (i.e., ActiGraph wrist-worn activity watch, smart phone app).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>Participants with Multiple Sclerosis who meet eligibility criteria. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive Function - Ambulatory measurement via Dot Memory Test | Reported in terms of Euclidian distance/error Cognition Covariates may include: age, sex, disease duration, Multiple Sclerosis (MS) subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary). | Baseline up to year 2 | 
| Change in Cognitive Function - Ambulatory measurement via Symbol Search Test | Reported in Reaction Time (milliseconds) Cognition Covariates may include: age, sex, disease duration, Multiple Sclerosis (MS) subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary). | Baseline up to year 2 | 
| Change in Cognitive Function - clinic-based neurocognitive measurement via NIH Toolbox Cognitive Battery | Test Battery reported in T-scores. Covariates may include: age, sex, disease duration, MS subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary). | Baseline up to year 2 | 
| Change in Cognitive Function - clinic-based neurocognitive measurement via Symbol Digit Modalities test | Covariates may include: age, sex, disease duration, MS subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary). The score is the number of correct answers in 90 seconds. Higher scores indicates better attention and processing speed. | Baseline up to year 2 | 
| Change in Cognitive Function - clinic-based neurocognitive measurement via Paced Auditory Serial Addition Test | Covariates may include: age, sex, disease duration, MS subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary). The score range is 0-60 and higher numbers indicate better sustained attention, speed of information processing, and working memory. | Baseline up to year 2 | 
| Change in Cognitive Function - clinic-based neurocognitive measurement via Rey Auditory Verbal Learning Test | Covariates may include: age, sex, disease duration, MS subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary). The scores from the test represent the total immediate recall (over 5 learning trials), delayed recall, and recognition. Higher scores indicate better verbal learning and memory. | Baseline up to year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive dysfunction