Combating Age-related Failure of Myelination in Multiple Sclerosis: An Exploratory Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Observation.
- Кому может быть актуально
- Состояния в реестре: Multiple Sclerosis. Базовые параметры: 50 лет — 70 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Combating Age-related Failure of Myelination in Multiple Sclerosis: an Exploratory Study
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Observation
No intervention is administered. Participants undergo observational assessments including MRI, wearable activity monitoring, and questionnaires.
Первичные конечные точки
- Quantitative MRI-derived myelin measure [Срок оценки: Baseline and 6 months]
Вторичные конечные точки (7)
- Total step count [Срок оценки: Continuously collected during the 6-month study period]
- Self-reported physical activity [Срок оценки: Baseline and monthly for the 6-month study period]
- Multiple Sclerosis Functional Composite (MSFC) [Срок оценки: baseline and 6 months]
- Low Contrast Letter Acuity [Срок оценки: Baseline and 6 months]
- Time spent in moderate-to-vigorous physical activity (MVPA) [Срок оценки: Throughout the 6-month period]
- Sedentary Time [Срок оценки: Throughout the 6-month period]
- Self-reported sedentary time [Срок оценки: Baseline and monthly throughout the 6-month period]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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.)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Multiple Sclerosis Center at UW Medical Center - Northwest — Seattle
Идентификаторы
NCT: NCT07723599 · STUDY00025928