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

NCT ID: NCT05252195

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-24

Study Completion Date

2027-03-31

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants

Participants with Multiple Sclerosis who meet eligibility criteria.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Wayne State University

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Anna Kratz

Associate Professor of Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Kratz

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Nora Fritz

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39325510 (View on PubMed)

Other Identifiers

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5R01HD102337-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00199732

Identifier Type: -

Identifier Source: org_study_id

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