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

NCT05252195 | Active Not Recruiting

• 2 other identifiers: HUM001997325R01HD102337-04
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Sclerosis

Keywords

Cognitive dysfunction

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Participants

Participants with Multiple Sclerosis who meet eligibility criteria.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants include a diverse sample of patients with MS

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (3)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Kratz AL, Ehde DM, Alschuler KN, Pickup K, Ginell K, Fritz NE. Optimizing Detection and Prediction of Cognitive Function in Multiple Sclerosis With Ambulatory Cognitive Tests: Protocol for the Longitudinal Observational CogDetect-MS Study. JMIR Res Protoc. 2024 Sep 26;13:e59876. doi: 10.2196/59876.

  PMID: 39325510 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Anna Kratz

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Nora Fritz

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: February 12, 2022
• First Posted: February 23, 2022
• Study Start: May 24, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)