Computerized Cognitive Rehabilitation in MS Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cognitive Functioning
研究概览
简要总结
This study examines a home-based computerized cognitive rehabilitation intervention in adults with multiple sclerosis compared to placebo (videogame). Patients are assessed through pre-and post neuropsychological testing.
详细描述
Patients will be randomized to enter a 6 week course of computer based cognitive rehabilitation focused on improving attention, learning, and memory. Control patients will receive an alternative home-based computer program not designed for cognitive remediation but of the same duration.
The primary outcome will be performance on neuropsychological testing in the intervention sample compared to controls. Secondary outcomes will be the measures of self-efficacy, work productivity, quality of life, fatigue, depression, anxiety, and healthcare utilization. Healthcare utilization variables include annual total cost (current year and prior), number and cost of ER/hospital/outpatient visits, number of hospital visits, hospital length of stay, number preventive visits, total number claims, and number of new medications initiated. In addition, acute changes in neuropsychological testing induced by a bout of physical activity (i.e. self-paced walking during the Six-Minute Walk Test) will be examined, and that pattern of change will be compared between intervention and control groups at each data collection point.
Each subject will participate for a total of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple sclerosis with cognitive complaint
排除标准
- •Patients unwilling to participate
- •Patients who cannot attend NPT sessions
- •Patients with severe cognitive impairment
- •Non-English speaking patients (testing materials are in English)
- •Patients with intact neuropsychological functioning at baseline on testing
结局指标
主要结局
Cognitive Functioning
时间窗: 6 Months
Compare between groups differences in attention (auditory and visual working memory), processing speed (automatic and controlled speed), executive functioning (verbal fluency and mental flexibility), and memory (immediate and delayed verbal and visual modalities) at completion of intervention, 3 months and 6 months using standardized scores.
次要结局
- Hospital Anxiety and Depression Scale(6 months)
- Healthcare Utilization(12 Months)
- Multiple Sclerosis Self-Efficacy Scale(6 Months)
- Work Productivity and Activity Impairment Instrument(6 months)
- Multiple Sclerosis Quality of Life Inventory(6 months)
研究者
Vikram Bhise, MD
Associate Professor
Rutgers, The State University of New Jersey