Optimizing Detection and Prediction of Changes in Cognitive Function in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Change in Cognitive Function - clinic-based neurocognitive measurement via Symbol Digit Modalities test
研究概览
简要总结
The researchers will use technology-assisted ambulatory assessment techniques to examine cognitive dysfunction in people with Multiple Sclerosis (MS).
The researchers will determine if ambulatory assessments are sensitive to subtle declines in cognitive functioning. They will also explore the impact of modifiable factors, such as sleep, physical activity, mood, and somatic symptoms on cognitive function. These efforts will uncover behavioral and medical intervention methods. Finally, they will explore whether variability in cognitive functioning predicts short- and long-term changes in other patient-centered functional domains, social participation and physical functioning.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are able to fluently converse and read in English.
- •Multiple Sclerosis (MS) diagnosis (confirmed from neurologist, all relapsing and progressive subtypes included)
- •Ambulate either independently or with the use of a cane or walker (or similar device) for at least 50% of the time at baseline
排除标准
- •MS relapse within the past 30 days (may become eligible after 30 days; criteria used at T1, T2, and T3).
- •Inability to use study data collection tools (i.e., ActiGraph wrist-worn activity watch, smart phone app).
结局指标
主要结局
Change in Cognitive Function - clinic-based neurocognitive measurement via Symbol Digit Modalities test
时间窗: Baseline up to year 2
Covariates may include: age, sex, disease duration, MS subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary). The score is the number of correct answers in 90 seconds. Higher scores indicates better attention and processing speed.
Change in Cognitive Function - Ambulatory measurement via Dot Memory Test
时间窗: Baseline up to year 2
Reported in terms of Euclidian distance/error Cognition Covariates may include: age, sex, disease duration, Multiple Sclerosis (MS) subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary).
Change in Cognitive Function - Ambulatory measurement via Symbol Search Test
时间窗: Baseline up to year 2
Reported in Reaction Time (milliseconds) Cognition Covariates may include: age, sex, disease duration, Multiple Sclerosis (MS) subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary).
Change in Cognitive Function - clinic-based neurocognitive measurement via Paced Auditory Serial Addition Test
时间窗: Baseline up to year 2
Covariates may include: age, sex, disease duration, MS subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary). The score range is 0-60 and higher numbers indicate better sustained attention, speed of information processing, and working memory.
Change in Cognitive Function - clinic-based neurocognitive measurement via NIH Toolbox Cognitive Battery
时间窗: Baseline up to year 2
Test Battery reported in T-scores. Covariates may include: age, sex, disease duration, MS subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary).
Change in Cognitive Function - clinic-based neurocognitive measurement via Rey Auditory Verbal Learning Test
时间窗: Baseline up to year 2
Covariates may include: age, sex, disease duration, MS subtype (relapsing vs. progressive subtypes combined), personality variables, and cognitive reserve (education plus scores on test of vocabulary). The scores from the test represent the total immediate recall (over 5 learning trials), delayed recall, and recognition. Higher scores indicate better verbal learning and memory.
次要结局
未报告次要终点
研究者
Anna Kratz
Associate Professor of Physical Medicine and Rehabilitation
University of Michigan