Multiple SclerosisNCT05252195
Optimizing Detection and Prediction of Changes in Cognitive Function in Multiple Sclerosis (MS)
An observational study of Multiple Sclerosis, run by University of Michigan at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 May 2022to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants include a diverse sample of patients with MS
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
Wayne State University
Detroit, Michigan, 48202
University of Washington
Seattle, Washington, 98195
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Cognitive dysfunction
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Participants with Multiple Sclerosis who meet eligibility criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start24 May 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Wayne State University, University of Washington
- Responsible party
- Principal investigator, Anna Kratz, University of Michigan
- Investigators
- Anna Kratz, Principal investigator, University of MichiganNora Fritz, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252195
- Sponsor's protocol ID
- HUM00199732
- Other IDs
- 5R01HD102337-04
- Status last verified
- Mar 2025
- First submitted
- 12 Feb 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39325510
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Detection and Prediction of Changes in Cognitive Function in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05252195
- Acronym / sponsor ID
- HUM00199732
- Conditions
- Multiple Sclerosis
- Keywords
- Cognitive dysfunction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Wayne State University, University of Washington
- Study start
- 24 May 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –Participants with Multiple Sclerosis who meet eligibility criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants include a diverse sample of patients with MS
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
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).
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Derived from this study: PubMed 39325510Kratz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Kratz principal investigator
University of Michigan
Nora Fritz principal investigator
Wayne State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of Michigan at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function - Ambulatory measurement via Dot Memory Test (time frame: Baseline up to year 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05252195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.