Combating Age-related Failure of Myelination in Multiple Sclerosis: An Exploratory Study (MAPMyeMS)
20 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Stimato)
14
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Susan R Robles, BS
- Numero di telefono: 206-598-0501
- Email: msstudy@uw.edu
Luoghi di studio
-
-
Washington
-
Seattle, Washington, Stati Uniti, 98133
- Multiple Sclerosis Center at UW Medical Center - Northwest
-
Contatto:
- Susan R Robles, BS
- Numero di telefono: 206-598-0501
- Email: msstudy@uw.edu
-
Investigatore principale:
- Sarah B Simmons, MD, PhD
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Participants will include adults age 50-70 (inclusive) with a diagnosis of multiple sclerosis in the Greater Seattle area.
Descrizione
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.)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
No intervention is administered.
Participants undergo observational assessments including MRI, wearable activity monitoring, and questionnaires.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Quantitative MRI-derived myelin measure
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Total step count
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Baseline and 6 months
|
The LCLA assesses visual function
|
Baseline and 6 months
|
|
Time spent in moderate-to-vigorous physical activity (MVPA)
Lasso di tempo: Throughout the 6-month period
|
MVPA will be measured via wrist-worn physical activity monitor
|
Throughout the 6-month period
|
|
Sedentary Time
Lasso di tempo: Throughout the 6-month period
|
Sedentary Time will be measured via wrist-worn fitness tracker
|
Throughout the 6-month period
|
|
Self-reported sedentary time
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Physical Function
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 agosto 2026
Completamento primario (Stimato)
1 giugno 2027
Completamento dello studio (Stimato)
1 luglio 2027
Date di iscrizione allo studio
Primo inviato
15 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
20 luglio 2026
Primo Inserito (Effettivo)
23 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY00025928
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Study data may be shared in de-identified form with outside researchers and collaborators as requested and deemed acceptable by study investigators.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .