Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
研究概览
简要总结
Multiple sclerosis (MS) is the most common progressive neurologic disorder to occur in adults of working-age. Despite longstanding recognition of cognitive impairment as a symptom of MS, two obstacles in measurement have limited understanding its biological basis, and therefore identifying targeted options for management. First is the absence of a sensitive and precise measure of cognitive impairment. Second is the absence of an index of disease status linked to brain pathophysiology and cognitive performance. This project overcomes both obstacles to link cognitive impairment to MS disease biomarkers. The absence of a sensitive and precise measure of cognitive impairment, along with the absence of an index of disease status linked to brain pathophysiology and cognitive performance, limits the understanding of the biological basis for multiple sclerosis (MS). This project overcomes both obstacles to link cognitive function to MS disease biomarkers, and provides preliminary evaluation of a disease modifying therapy (Tecfidera) for preserving cognitive function.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •Male and Female subjects between 18 and 45 years
- •WRAT-4 Reading [127] standard score > 85
- •Able to undergo neuroimaging data collection procedures. For MS Participants
- •Definite diagnosis of RRMS [128]
- •EDSS of 0 to 6.0
- •Adequate vision as as reported by the participant (with correction if applicable)
- •Clinically prescribed Tecfidera, Tysabri or Ocrevus therapy by treating neurologist, with first dose being within 3 months + 14 days from baseline visit
- •At baseline visit, concurrent medications to be kept constant over three months prior to data collection visits
- •No relapse or steroids in previous month
排除标准
- •Unable or unwilling to provide informed consent.
- •Beck Depression Inventory-Fast Screen (BDI-FS) [129, 130] score of 4 or more
- •Current alcohol or other substance use disorder
- •Primary psychiatric disorder that would adversely influence ability to participate
- •Other neurological condition associated with cognitive impairment (e.g., epilepsy, brain injury)
- •Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
- •Learned English language after 12 years of age
- •For low absolute low lymphocyte count (ALC), USPI guidance will be utilized.
- •For MS participants:
- •Lemtrada, Cladribine, Mitoxantrone
结局指标
主要结局
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
时间窗: 12 Months
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
次要结局
未报告次要终点