Combating Age-related Failure of Myelination in Multiple Sclerosis: An Exploratory Study (MAPMyeMS)
20 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
De observación
Inscripción (Estimado)
14
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Susan R Robles, BS
- Número de teléfono: 206-598-0501
- Correo electrónico: msstudy@uw.edu
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98133
- Multiple Sclerosis Center at UW Medical Center - Northwest
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Contacto:
- Susan R Robles, BS
- Número de teléfono: 206-598-0501
- Correo electrónico: msstudy@uw.edu
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Investigador principal:
- Sarah B Simmons, MD, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Participants will include adults age 50-70 (inclusive) with a diagnosis of multiple sclerosis in the Greater Seattle area.
Descripción
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.)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quantitative MRI-derived myelin measure
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total step count
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physical Function
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de junio de 2027
Finalización del estudio (Estimado)
1 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
15 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de julio de 2026
Publicado por primera vez (Actual)
23 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Comportamiento
- Esclerosis múltiple
- Enfermedades desmielinizantes
- Actividad del motor
- Técnicas de investigación
- Métodos
- Observación
Otros números de identificación del estudio
- STUDY00025928
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Study data may be shared in de-identified form with outside researchers and collaborators as requested and deemed acceptable by study investigators.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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