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

Active, not recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT05252195
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-12
• Study First Submitted QC: 2022-02-12
• Study First Posted: 2022-02-23
• Study Start: 2022-05-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Cognitive Function - clinic-based neurocognitive measurement via Symbol Digit Modalities test	Baseline up to year 2	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.
Change in Cognitive Function - Ambulatory measurement via Dot Memory Test	Baseline up to year 2	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).
Change in Cognitive Function - Ambulatory measurement via Symbol Search Test	Baseline up to year 2	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).
Change in Cognitive Function - clinic-based neurocognitive measurement via Paced Auditory Serial Addition Test	Baseline up to year 2	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.
Change in Cognitive Function - clinic-based neurocognitive measurement via NIH Toolbox Cognitive Battery	Baseline up to year 2	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).
Change in Cognitive Function - clinic-based neurocognitive measurement via Rey Auditory Verbal Learning Test	Baseline up to year 2	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.

Trial Locations

Locations (3)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

University of Washington; 🇺🇸 Seattle, Washington, United States