Combating Age-related Failure of Myelination in Multiple Sclerosis: An Exploratory Study (MAPMyeMS)
2026년 7월 20일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (추정된)
14
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Susan R Robles, BS
- 전화번호: 206-598-0501
- 이메일: msstudy@uw.edu
연구 장소
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Washington
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Seattle, Washington, 미국, 98133
- Multiple Sclerosis Center at UW Medical Center - Northwest
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연락하다:
- Susan R Robles, BS
- 전화번호: 206-598-0501
- 이메일: msstudy@uw.edu
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수석 연구원:
- Sarah B Simmons, MD, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
Participants will include adults age 50-70 (inclusive) with a diagnosis of multiple sclerosis in the Greater Seattle area.
설명
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.)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quantitative MRI-derived myelin measure
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total step count
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical Function
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2027년 6월 1일
연구 완료 (추정된)
2027년 7월 1일
연구 등록 날짜
최초 제출
2026년 7월 15일
QC 기준을 충족하는 최초 제출
2026년 7월 20일
처음 게시됨 (실제)
2026년 7월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 20일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00025928
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Study data may be shared in de-identified form with outside researchers and collaborators as requested and deemed acceptable by study investigators.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .