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NCT Number: NCT07723599

Combating Age-related Failure of Myelination in Multiple Sclerosis: An Exploratory Study

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.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Sclerosis Center at UW Medical Center - Northwest

Seattle, Washington, 98133, United States

Location contact

Sarah B Simmons, MD, PhD

PRINCIPAL_INVESTIGATOR

Susan R Robles, BS

CONTACT

[email protected]

206-598-0501

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

observation

Other

No intervention is administered. Participants undergo observational assessments including MRI, wearable activity monitoring, and questionnaires.

Primary outcomes

  1. Quantitative MRI-derived myelin measure

    Time frame: Baseline and 6 months

    Change in MRI-derived measures of myelin content within the central nervous system. Specifically, the investigators will use macromolecular proton fraction (MPF), a quantitative MRI parameter which describes the magnetization transfer effect and defined as the relative amount of protons bound to biological macromolecules with restricted molecular motion.

Secondary outcomes

  1. Total step count

    Time frame: Continuously collected during the 6-month study period

    Total step count will measured using wrist-worn activity tracker.

  2. Self-reported physical activity

    Time frame: Baseline and monthly for the 6-month study period

    Physical activity will be measured with the International Physical Activity Questionnaire-Short Form (IPAQ-SF). This questionnaire will ask participants about their moderate and vigorous physical activity and time spent walking, to give a total sum score of Metabolic Equivalent of Task (MET). Higher calculated (MET) scores indicate greater physical activity.

  3. Multiple Sclerosis Functional Composite (MSFC)

    Time frame: baseline and 6 months

    The MSFC assesses walking function, hand function, and cognitive function and gives a composite score.

  4. Low Contrast Letter Acuity

    Time frame: Baseline and 6 months

    The LCLA assesses visual function

  5. Time spent in moderate-to-vigorous physical activity (MVPA)

    Time frame: Throughout the 6-month period

    MVPA will be measured via wrist-worn physical activity monitor

  6. Sedentary Time

    Time frame: Throughout the 6-month period

    Sedentary Time will be measured via wrist-worn fitness tracker

  7. Self-reported sedentary time

    Time frame: Baseline and monthly throughout the 6-month period

    Self-reported sedentary time will be measured with the International Physical Activity Questionnaire-Short Form (IPAQ-SF). This questionnaire will ask participants about their time spent sitting over the past 7 days, as an estimate of sedentary time.

Other outcomes

  1. Physical Function

    Time frame: Baseline and 6 months

    Physical function will be measured using the PROMIS Physical Function-MS 15a. This self-report questionnaire assesses participants' physical functioning and ability to perform everyday activities.

  2. Diet Quality

    Time frame: Baseline and monthly for the 6-month study period.

    Diet will be measured using the Dietary Screener Questionnaire (DSQ), a self-report questionnaire that assesses the frequency of consumption of selected foods and beverages during the previous month to estimate intake of key dietary components, including fruits, vegetables, whole grains, dairy products, fiber, and added sugars. The outcome measure will be the total DSQ-derived diet quality score.

  3. Sleep Quality

    Time frame: Baseline and monthly for the 6-month study period.

    Sleep quality will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8a, version 1.0. Responses from each item will be summed to form a total raw score ranging from 8-40. Higher scores indicate higher self-reported levels of sleep disturbance.

  4. Stress

    Time frame: Baseline and monthly for the 6-month study period.

    Stress will be measured using the Perceived Stress Scale, a 10-item self-report questionnaire that measures the degree to which situations in an individual's life are appraised as stressful during the previous month. Higher scores indicate greater perceived stress. Raw scores range from 0 to 40 and use reverse scoring for some items.

  5. Depressive Symptom Severity

    Time frame: Baseline and monthly for the 6-month study period.

    This outcome will be measured using the Patient Health Questionnaire- 8 (PHQ-8), a 8-item self-report measure that assesses the frequency and severity of depressive symptoms experienced during the previous 2 weeks. Higher scores indicate greater depressive symptom burden.

  6. Fatigue Severity

    Time frame: Baseline and monthly for the 6-month study period.

    Fatigue will be measured using the Fatigue Severity Scale, a 9-item self-report questionnaire that evaluates the severity of fatigue and its impact on daily activities, work, family, and social functioning. Higher scores indicate greater fatigue severity.

  7. Alcohol Use

    Time frame: Baseline and monthly for the 6-month study period.

    This will be measured via the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), a 3-item screening measure that assesses alcohol consumption patterns, including drinking frequency, quantity, and frequency of heavy drinking episodes. Higher scores indicate greater alcohol use and risk for hazardous drinking.

  8. Cannabis Use

    Time frame: Baseline and monthly for the 6-month study period.

    This information will be collected through an adapted version of the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU), a self-report measure that assesses cannabis use history and patterns, including age of initiation, frequency of use, quantity consumed, and methods of administration.

  9. Tobacco Use

    Time frame: Baseline and monthly for the 6-month study period.

    This information will be collected through a self-developed questionnaire detailing self-reported tobacco and nicotine product use, including current use status, frequency of use, duration of use, and product type.

  10. Comorbidity Burden

    Time frame: Baseline and 6 months

    This information will be collected using a self-reported questionnaire of presence of physician-diagnosed medical and psychiatric comorbid conditions. Comorbidity burden may be summarized as the total number of reported comorbidities.

Study contacts

Contact information is provided by the study sponsor or research team.

Susan R Robles, BS

CONTACT

[email protected]

206-598-0501

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Acronym: MAPMyeMS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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