Combating Age-related Failure of Myelination in Multiple Sclerosis: an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Quantitative MRI-derived myelin measure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
结局指标
主要结局
Quantitative MRI-derived myelin measure
时间窗: 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.
次要结局
- Total step count(Continuously collected during the 6-month study period)
- Self-reported physical activity(Baseline and monthly for the 6-month study period)
- Multiple Sclerosis Functional Composite (MSFC)(baseline and 6 months)
- Low Contrast Letter Acuity(Baseline and 6 months)
- Time spent in moderate-to-vigorous physical activity (MVPA)(Throughout the 6-month period)
- Sedentary Time(Throughout the 6-month period)
- Self-reported sedentary time(Baseline and monthly throughout the 6-month period)
研究者
Sarah Simmons, MD, PhD
Assistant Professor, Rehabilitation Medicine
University of Washington