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

20 juli 2026 bijgewerkt door: Sarah Simmons, MD, PhD, University of Washington

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

14

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Susan R Robles, BS
  • Telefoonnummer: 206-598-0501
  • E-mail: msstudy@uw.edu

Studie Locaties

  • Verenigde Staten
    • Washington
      • Seattle, Washington, Verenigde Staten, 98133
        • Multiple Sclerosis Center at UW Medical Center - Northwest
        • Contact:
          • Susan R Robles, BS
          • Telefoonnummer: 206-598-0501
          • E-mail: msstudy@uw.edu
        • Hoofdonderzoeker:
          • Sarah B Simmons, MD, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Participants will include adults age 50-70 (inclusive) with a diagnosis of multiple sclerosis in the Greater Seattle area.

Beschrijving

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.)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Adults With Multiple Sclerosis
Participants with multiple sclerosis, age 50-70 (inclusive) will undergo quantitative MRI assessments, wearable activity monitoring, and questionnaire-based assessments over the study period.
Ander: Observation
No intervention is administered. Participants undergo observational assessments including MRI, wearable activity monitoring, and questionnaires.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quantitative MRI-derived myelin measure
Tijdsspanne: 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.
Baseline and 6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Total step count
Tijdsspanne: Continuously collected during the 6-month study period
Total step count will measured using wrist-worn activity tracker.
Continuously collected during the 6-month study period
Self-reported physical activity
Tijdsspanne: 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.
Baseline and monthly for the 6-month study period
Multiple Sclerosis Functional Composite (MSFC)
Tijdsspanne: baseline and 6 months
The MSFC assesses walking function, hand function, and cognitive function and gives a composite score.
baseline and 6 months
Low Contrast Letter Acuity
Tijdsspanne: Baseline and 6 months
The LCLA assesses visual function
Baseline and 6 months
Time spent in moderate-to-vigorous physical activity (MVPA)
Tijdsspanne: Throughout the 6-month period
MVPA will be measured via wrist-worn physical activity monitor
Throughout the 6-month period
Sedentary Time
Tijdsspanne: Throughout the 6-month period
Sedentary Time will be measured via wrist-worn fitness tracker
Throughout the 6-month period
Self-reported sedentary time
Tijdsspanne: 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.
Baseline and monthly throughout the 6-month period

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Physical Function
Tijdsspanne: 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.
Baseline and 6 months
Diet Quality
Tijdsspanne: 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.
Baseline and monthly for the 6-month study period.
Sleep Quality
Tijdsspanne: 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.
Baseline and monthly for the 6-month study period.
Stress
Tijdsspanne: 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.
Baseline and monthly for the 6-month study period.
Depressive Symptom Severity
Tijdsspanne: 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.
Baseline and monthly for the 6-month study period.
Fatigue Severity
Tijdsspanne: 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.
Baseline and monthly for the 6-month study period.
Alcohol Use
Tijdsspanne: 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.
Baseline and monthly for the 6-month study period.
Cannabis Use
Tijdsspanne: 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.
Baseline and monthly for the 6-month study period.
Tobacco Use
Tijdsspanne: 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.
Baseline and monthly for the 6-month study period.
Comorbidity Burden
Tijdsspanne: 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.
Baseline and 6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Washington

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 juli 2027

Studieregistratiedata

Eerst ingediend

15 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 juli 2026

Eerst geplaatst (Werkelijk)

23 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

20 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY00025928

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Study data may be shared in de-identified form with outside researchers and collaborators as requested and deemed acceptable by study investigators.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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