We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05252195
Recruitment Status : Recruiting
First Posted : February 23, 2022
Last Update Posted : August 15, 2022
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Wayne State University
University of Washington
Information provided by (Responsible Party):
Anna Kratz, University of Michigan

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Multiple Sclerosis

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimizing Detection and Prediction of Changes in Cognitive Function in Multiple Sclerosis
Actual Study Start Date : May 24, 2022
Estimated Primary Completion Date : March 2027
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Participants include a diverse sample of patients with MS
Criteria

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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05252195


Contacts
Layout table for location contacts
Contact: Kristi Pickup 734-764-4072 knpicku@umich.edu

Locations
Layout table for location information
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Kristi Pickup         
Principal Investigator: Anna Kratz         
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Nora Fritz         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: Kevin Alschuler         
Sponsors and Collaborators
University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Wayne State University
University of Washington
Investigators
Layout table for investigator information
Principal Investigator: Anna Kratz University of Michigan
Principal Investigator: Nora Fritz Wayne State University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Anna Kratz, Associate Professor of Physical Medicine and Rehabilitation, University of Michigan
ClinicalTrials.gov Identifier: NCT05252195    
Other Study ID Numbers: HUM00199732
R01HD102337-01 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2022    Key Record Dates
Last Update Posted: August 15, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Kratz, University of Michigan:
Cognitive dysfunction
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases