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

March 14, 2024 updated by: Anna Kratz, University of Michigan

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Wayne State University
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Participants include a diverse sample of patients with MS

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Participants
Participants with Multiple Sclerosis who meet eligibility criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline up to year 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).
Baseline up to year 2
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).
Baseline up to year 2
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.
Baseline up to year 2
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.
Baseline up to year 2
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.
Baseline up to year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

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

Investigators

  • Principal Investigator: Nora Fritz, Wayne State University
  • Principal Investigator: Anna Kratz, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 12, 2022

First Submitted That Met QC Criteria

February 12, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00199732
  • R01HD102337-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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