Plasticity-based, Adaptive, Computerized Cognitive Remediation Treatment (PACR) for Adults With Multiple Sclerosis (MS)
试验速览
- 阶段
- 不适用
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- A composite derived from a standardized battery of neuropsychological tests
研究概览
简要总结
Cognitive impairment remains a major disability for individuals with multiple sclerosis (MS). The primary objective of this study is to evaluate the efficacy for treating MS-associated cognitive deficits using a unique computer-based plasticity-based and adaptive cognitive remediation treatment (PACR) compared to a computer-based control. This novel cognitive remediation approach has led to striking improvements in cognitive functioning in other disorders (schizophrenia, traumatic brain injury, aging, and dementia) but has never been applied to individuals with MS. The investigators will enroll 136 MS participants who will be randomized in a 2:1 pattern to complete either the treatment or control condition for 60 hours across a 12-week treatment period. Both the treatment and control conditions will be accessed remotely by the subjects from a study-provided laptop computer. Study outcomes will include program compliance, performance on study tasks and neuropsychological measures, quality of life and functional status. Given the success of this program with other disorders and strong preliminary data from our feasibility study, the investigators believe PACR is an exciting untapped opportunity to improve cognition in individuals with MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-70
- •Definite MS Diagnosis, any subtype [83]
- •Probable cognitive impairment as defined by a score ≤ 1 SD below the mean of normative data on the SDMT
- •Concurrent medications to be kept constant over three months (as possible)
- •No relapse or steroids in previous month
- •Reading score on WRAT-3 of 37 or greater
- •Visual, auditory and motor capacity to operate computer software, as judged by treating neurologist or study staff
- •Willing to sign Agreement to Borrow Laptop
排除标准
- •History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
- •Primary psychiatric disorder that would influence ability to participate
- •Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
- •Alcohol or other substance use disorder
- •History of computer-based training manufactured by Posit Science
- •Learned English language after 12 years of age
结局指标
主要结局
A composite derived from a standardized battery of neuropsychological tests
时间窗: 12weeks
Covariates will include baseline cognitive status, PACR program compliance, PACR task improvement, and participant-reported outcomes
次要结局
- A timed measure based on direct observation of functional performance(12 weeks)
研究者
Lauren Krupp
Professor
Stony Brook University