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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05252195
• Other study ID #: HUM00199732
• Secondary ID: R01HD102337-01
• Status: Active, not recruiting
• Start date: May 24, 2022
• Est. completion date: March 2027

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Wayne State University	Detroit	Michigan
United States	University of Washington	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Washington, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline up to year 2
Primary	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).	Baseline up to year 2
Primary	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).	Baseline up to year 2
Primary	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.	Baseline up to year 2
Primary	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.	Baseline up to year 2
Primary	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.	Baseline up to year 2