Allocentric Memory as a Novel Measure of Cognitive Inefficiency: Sensitivity in Multiple Sclerosis (MS) Subjects and Relationship With Resting State Functional MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Minimal Assessment of Cognitive Function in MS (MACFIMS)
研究概览
简要总结
The goals of this study are to 1. Investigate the sensitivity of allocentric visual memory when compared to more established measures of cognition in identifying cognitive difficulties among MS subjects when compared to controls. 2. Determine which cognitive test variable will be most strongly associated with self and informant reports of cognition. 3. Determine which MRI metric will be most strongly related to neuropsychological test performance 4. Determine the degree to which allocentric visual memory is related to functional connectivity on fMRI.
详细描述
This is a cross-sectional, case-control, observational experimental design. The study will enroll subjects with multiple sclerosis (MS) and age/gender matched on a battery of neuropsychological cognitive tests and self-report measures of cognition.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-55 years old
- •Right handed
- •Capacity to provide informed consent and sign consent
- •Diagnosis of Relapsing Remitting MS that meets the revised McDonald Criteria (2010) within the last 10 years
- •EDSS 0- 5.5
排除标准
- •Diagnosis of primary progressive MS
- •Contraindications for MRI
- •Subjects required to take medications known to either benefit or adversely affect cognition at the time of testing and impact neuroimaging
- •Non-MS neurological disorders
- •Other medical or psychiatric disorders likely to affect cognitive performance
- •Active immunodeficiency, chronic infections, or history or progressive multifocal leukoencephalopathy
- •Individuals with severe level of depression on the BDI-II or severe anxiety on the BAI
- •MS subjects who are actively experiencing acute exacerbation in symptoms and they must be at least 4 weeks free of steroid medication, are currently taking a chemotherapy agent, or have changed medication in the last two months
- •Subjects who fail symptom validity measures during neuropsychological testing will be excluded
结局指标
主要结局
Minimal Assessment of Cognitive Function in MS (MACFIMS)
时间窗: Baseline
The MACFIMS is composed of seven neuropsychological tests, covering five cognitive domains commonly impaired in MS (processing speed/working memory, learning and memory, executive function, visual-spatial processing and word retrieval)
次要结局
未报告次要终点