Clinical trial NCT05252195: Optimizing Detection and Prediction of Changes in Cognitive Function in Multiple Sclerosis (MS)
Official title: Optimizing Detection and Prediction of Changes in Cognitive Function in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Keywords: Cognitive dysfunction
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Wayne State University
name: University of Washington
First posted: 2022-02-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants include a diverse sample of patients with MS

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.


Eligibility 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).

Primary outcomes:
measure: Change in Cognitive Function - Ambulatory measurement via Dot Memory Test
timeFrame: Baseline up to year 2
measure: Change in Cognitive Function - Ambulatory measurement via Symbol Search Test
timeFrame: Baseline up to year 2
measure: Change in Cognitive Function - clinic-based neurocognitive measurement via NIH Toolbox Cognitive Battery
timeFrame: Baseline up to year 2
measure: Change in Cognitive Function - clinic-based neurocognitive measurement via Symbol Digit Modalities test
timeFrame: Baseline up to year 2
measure: Change in Cognitive Function - clinic-based neurocognitive measurement via Paced Auditory Serial Addition Test
timeFrame: Baseline up to year 2
measure: Change in Cognitive Function - clinic-based neurocognitive measurement via Rey Auditory Verbal Learning Test
timeFrame: Baseline up to year 2
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Michigan
name: Anna Kratz
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Nora Fritz
role: PRINCIPAL_INVESTIGATOR
References: