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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (推定)

14

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Susan R Robles, BS
  • 電話番号：206-598-0501
  • メール：msstudy@uw.edu

研究場所

  • アメリカ
    • Washington
      • Seattle、Washington、アメリカ、98133
        • Multiple Sclerosis Center at UW Medical Center - Northwest
        • コンタクト：
          • Susan R Robles, BS
          • 電話番号：206-598-0501
          • メール：msstudy@uw.edu
        • 主任研究者：
          • Sarah B Simmons, MD, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
他の：Observation
No intervention is administered. Participants undergo observational assessments including MRI, wearable activity monitoring, and questionnaires.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Quantitative MRI-derived myelin measure
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Total step count
時間枠：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
時間枠：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)
時間枠：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
時間枠：Baseline and 6 months
The LCLA assesses visual function
Baseline and 6 months
Time spent in moderate-to-vigorous physical activity (MVPA)
時間枠：Throughout the 6-month period
MVPA will be measured via wrist-worn physical activity monitor
Throughout the 6-month period
Sedentary Time
時間枠：Throughout the 6-month period
Sedentary Time will be measured via wrist-worn fitness tracker
Throughout the 6-month period
Self-reported sedentary time
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Physical Function
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Washington

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2027年7月1日

試験登録日

最初に提出

2026年7月15日

QC基準を満たした最初の提出物

2026年7月20日

最初の投稿 (実際)

2026年7月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月23日

QC基準を満たした最後の更新が送信されました

2026年7月20日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • STUDY00025928

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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いいえ

米国FDA規制機器製品の研究

いいえ

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