Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05252195

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cognition Disorders Cognitive Dysfunction Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan, Ann Arbor, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Change in Cognitive Function - Ambulatory measurement via Dot Memory Test

    Time frame: 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).

  2. Change in Cognitive Function - Ambulatory measurement via Symbol Search Test

    Time frame: 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).

  3. Change in Cognitive Function - clinic-based neurocognitive measurement via NIH Toolbox Cognitive Battery

    Time frame: 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).

  4. Change in Cognitive Function - clinic-based neurocognitive measurement via Symbol Digit Modalities test

    Time frame: 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.

  5. Change in Cognitive Function - clinic-based neurocognitive measurement via Paced Auditory Serial Addition Test

    Time frame: 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.

  6. Change in Cognitive Function - clinic-based neurocognitive measurement via Rey Auditory Verbal Learning Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Washington
  • Wayne State University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2022
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.