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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05252195
Other study ID # HUM00199732
Secondary ID R01HD102337-01
Status Active, not recruiting
Phase
First received
Last updated
Start date May 24, 2022
Est. completion date March 2027

Study information

Verified date March 2024
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date March 2027
Est. primary completion date March 2027
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Are able to fluently converse and read in English. 2. Multiple Sclerosis (MS) diagnosis (confirmed from neurologist, all relapsing and progressive subtypes included) 3. 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: 1. MS relapse within the past 30 days (may become eligible after 30 days; criteria used at T1, T2, and T3). 2. Inability to use study data collection tools (i.e., ActiGraph wrist-worn activity watch, smart phone app).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Wayne State University Detroit Michigan
United States University of Washington Seattle Washington

Sponsors (4)

Lead Sponsor Collaborator
University of Michigan Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Washington, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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