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

2026年7月20日更新者：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.

研究概览

地位

尚未招聘

条件

多发性硬化症

干预/治疗

其他：Observation

详细说明

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.

研究类型

观察性的

注册 (估计的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Susan R Robles, BS
电话号码：206-598-0501
邮箱：msstudy@uw.edu

学习地点

美国
- Washington
  - Seattle、Washington、美国、98133
    - Multiple Sclerosis Center at UW Medical Center - Northwest
    - 接触：
      
      Susan R Robles, BS
      
      电话号码：206-598-0501
      
      邮箱：msstudy@uw.edu
    - 首席研究员：
      
      Sarah B Simmons, MD, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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

描述

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.)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列	干预/治疗
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.	其他：Observation No intervention is administered. Participants undergo observational assessments including MRI, wearable activity monitoring, and questionnaires.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Quantitative MRI-derived myelin measure 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Total step count 大体时间：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 大体时间：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) 大体时间：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 大体时间：Baseline and 6 months	The LCLA assesses visual function	Baseline and 6 months
Time spent in moderate-to-vigorous physical activity (MVPA) 大体时间：Throughout the 6-month period	MVPA will be measured via wrist-worn physical activity monitor	Throughout the 6-month period
Sedentary Time 大体时间：Throughout the 6-month period	Sedentary Time will be measured via wrist-worn fitness tracker	Throughout the 6-month period
Self-reported sedentary time 大体时间：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

其他结果措施

结果测量	措施说明	大体时间
Physical Function 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Washington

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2026年7月15日

首先提交符合 QC 标准的

2026年7月20日

首次发布 (实际的)

2026年7月23日

研究记录更新

最后更新发布 (实际的)

2026年7月23日

上次提交的符合 QC 标准的更新

2026年7月20日

最后验证

2026年7月1日

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