Combating Age-related Failure of Myelination in Multiple Sclerosis: An Exploratory Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observation.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 50 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Combating Age-related Failure of Myelination in Multiple Sclerosis: an Exploratory Study
Overview
This observational, longitudinal study will examine whether physical activity and other potentially modifiable lifestyle factors are associated with changes in myelin, the protective coating around nerve fibers, in older adults with multiple sclerosis (MS). Participants will undergo magnetic resonance imaging (MRI) scans to measure myelin throughout the central nervous system and will wear wrist-worn activity trackers to assess physical activity over time.
Detailed description
The primary aim of this study is to explore clinical variables and potentially modifiable risk factors that are associated with improved myelination (both enhanced remyelination and reduced demyelination) in older adults living with multiple sclerosis. The emphasis here will be on discovery and generation of pilot data to support further definitive longitudinal observational studies, and ultimately, clinical trials on behavioral and/or pharmaceutical interventions to prevent demyelination and promote remyelination in people living with MS.
Participants will be categorized based on whether they meet or exceed the current physical activity guidelines of at least 150 minutes per week of moderate-intensity aerobic physical activity, 75 minutes per week of vigorous-intensity aerobic physical activity, or an equivalent combination.
At both baseline and 6 months, MRI and clinical assessments will be obtained, and chart review will be performed. Participants will wear a wrist-worn physical activity monitor and answer monthly questionnaires (assessed via REDCap survey) throughout the study period.
Linear regression will be performed to estimate the effect size of various physical activity variables (step count, sedentary time, and time spent in light/moderate/vigorous physical activity, aerobic capacity and overall strength) with 6-month change in myelination.
Interventions
- Other Observation
No intervention is administered. Participants undergo observational assessments including MRI, wearable activity monitoring, and questionnaires.
Primary outcome measures
- Quantitative MRI-derived myelin measure [Time frame: Baseline and 6 months]
Secondary outcome measures (7)
- Total step count [Time frame: Continuously collected during the 6-month study period]
- Self-reported physical activity [Time frame: Baseline and monthly for the 6-month study period]
- Multiple Sclerosis Functional Composite (MSFC) [Time frame: baseline and 6 months]
- Low Contrast Letter Acuity [Time frame: Baseline and 6 months]
- Time spent in moderate-to-vigorous physical activity (MVPA) [Time frame: Throughout the 6-month period]
- Sedentary Time [Time frame: Throughout the 6-month period]
- Self-reported sedentary time [Time frame: Baseline and monthly throughout the 6-month period]
Eligibility criteria
Inclusion criteria
- Diagnosis of multiple sclerosis
- Independent with ambulation (able to walk 500m without aid)
- Disease duration >10 years
- Age 50 to 70 years (inclusive)
- Be able to read, speak, and understand English
Exclusion criteria
- Diagnosis of other neurologic disease that would interfere with interpretation such as stroke, myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), neuromyelitis optica (NMO), and sarcoidosis.
- Inability to complete study procedures (including obtaining MRI at BMIC and using Fitbit connected to smartphone)
- Currently participating in another clinical trial on remyelination
- Pregnancy. (Pregnancy status will be asked at screening and before each MRI. Pregnancy testing will not be offered as part of this study.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Multiple Sclerosis Center at UW Medical Center - Northwest — Seattle
Identifiers
NCT: NCT07723599 · STUDY00025928