Combating Age-related Failure of Myelination in Multiple Sclerosis: An Exploratory Study (MAPMyeMS)
20. července 2026 aktualizováno: 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.
Přehled studie
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Odhadovaný)
14
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Susan R Robles, BS
- Telefonní číslo: 206-598-0501
- E-mail: msstudy@uw.edu
Studijní místa
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Washington
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Seattle, Washington, Spojené státy, 98133
- Multiple Sclerosis Center at UW Medical Center - Northwest
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Kontakt:
- Susan R Robles, BS
- Telefonní číslo: 206-598-0501
- E-mail: msstudy@uw.edu
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Vrchní vyšetřovatel:
- Sarah B Simmons, MD, PhD
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Participants will include adults age 50-70 (inclusive) with a diagnosis of multiple sclerosis in the Greater Seattle area.
Popis
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.)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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.
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No intervention is administered.
Participants undergo observational assessments including MRI, wearable activity monitoring, and questionnaires.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Quantitative MRI-derived myelin measure
Časové okno: Baseline and 6 months
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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.
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Baseline and 6 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Total step count
Časové okno: Continuously collected during the 6-month study period
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Total step count will measured using wrist-worn activity tracker.
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Continuously collected during the 6-month study period
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Self-reported physical activity
Časové okno: Baseline and monthly for the 6-month study period
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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.
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Baseline and monthly for the 6-month study period
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Multiple Sclerosis Functional Composite (MSFC)
Časové okno: baseline and 6 months
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The MSFC assesses walking function, hand function, and cognitive function and gives a composite score.
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baseline and 6 months
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Low Contrast Letter Acuity
Časové okno: Baseline and 6 months
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The LCLA assesses visual function
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Baseline and 6 months
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Time spent in moderate-to-vigorous physical activity (MVPA)
Časové okno: Throughout the 6-month period
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MVPA will be measured via wrist-worn physical activity monitor
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Throughout the 6-month period
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Sedentary Time
Časové okno: Throughout the 6-month period
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Sedentary Time will be measured via wrist-worn fitness tracker
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Throughout the 6-month period
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Self-reported sedentary time
Časové okno: Baseline and monthly throughout the 6-month period
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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.
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Baseline and monthly throughout the 6-month period
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Physical Function
Časové okno: Baseline and 6 months
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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.
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Baseline and 6 months
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Diet Quality
Časové okno: Baseline and monthly for the 6-month study period.
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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.
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Baseline and monthly for the 6-month study period.
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Sleep Quality
Časové okno: Baseline and monthly for the 6-month study period.
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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.
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Baseline and monthly for the 6-month study period.
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Stress
Časové okno: Baseline and monthly for the 6-month study period.
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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.
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Baseline and monthly for the 6-month study period.
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Depressive Symptom Severity
Časové okno: Baseline and monthly for the 6-month study period.
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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.
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Baseline and monthly for the 6-month study period.
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Fatigue Severity
Časové okno: Baseline and monthly for the 6-month study period.
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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.
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Baseline and monthly for the 6-month study period.
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Alcohol Use
Časové okno: Baseline and monthly for the 6-month study period.
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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.
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Baseline and monthly for the 6-month study period.
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Cannabis Use
Časové okno: Baseline and monthly for the 6-month study period.
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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.
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Baseline and monthly for the 6-month study period.
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Tobacco Use
Časové okno: Baseline and monthly for the 6-month study period.
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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.
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Baseline and monthly for the 6-month study period.
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Comorbidity Burden
Časové okno: Baseline and 6 months
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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.
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Baseline and 6 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. srpna 2026
Primární dokončení (Odhadovaný)
1. června 2027
Dokončení studie (Odhadovaný)
1. července 2027
Termíny zápisu do studia
První předloženo
15. července 2026
První předloženo, které splnilo kritéria kontroly kvality
20. července 2026
První zveřejněno (Aktuální)
23. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
23. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STUDY00025928
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Study data may be shared in de-identified form with outside researchers and collaborators as requested and deemed acceptable by study investigators.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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