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临床试验/NCT03836963
NCT03836963已完成不适用

Cognitive Rehabilitation for Veterans With Parkinson's Disease

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
Change in NIH Sponsored Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH-EXAMINER) Executive Composite Score

研究概览

简要总结

This study will examine the feasibility of an at-home cognitive training program that incorporates both memory training and online computerized cognitive training (CCT) software. Data will also be collected to determine if this program improves thinking and memory as well as everyday function. The hypothesis is that memory and cognitive training combined , compared to memory training alone or will lead to greater improvements in cognitive performance and daily function.

详细描述

The objective of this study is to examine feasibility of an at-home cognitive rehabilitation program that incorporates both prospective implementation intentions strategies (PRIIS) and an existing web-based executive function (EF) computerized cognitive training (CCT) software for Veterans with Parkinson's disease (PD) and to collect pilot data to determine the impact of this program on cognition and everyday function. The central hypothesis is that CCT+PRIIS, compared to CCT alone and an active control group, will lead to greater improvements in cognitive performance and daily function. This innovative study uses a set of on-line training games that target aspects of EF susceptible in PD and trains the transfer of cognitive benefits to everyday function, using PRIIS, for Veterans with PD and mild cognitive impairment in executive function. Additionally, training is conducted at home allowing for convenience and flexibility for participants.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Veterans who seek services at Hines VA Hospital
  • Diagnosis of PD as determined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
  • Meet criteria for having mild cognitive impairment
  • Receiving stable (i.e., no changes in medication and medication dose) medication and who are expected to remain on stable medication for the duration of the RCT
  • 50 years or older
  • Speak and read English

排除标准

  • Failure to demonstrate decision making capacity
  • Cholinesterase inhibitor medication
  • History of deep brain stimulation surgery
  • Severe depression
  • Severe anxiety
  • Severe apathy

结局指标

主要结局

Change in NIH Sponsored Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH-EXAMINER) Executive Composite Score

时间窗: week 0 (before intervention begins), 8 weeks

The NIH-EXAMINER has an established 3-factor model defined by (1) cognitive control, (2) working memory (3) fluency. A confirmatory factor analysis indicates these 3-factors load on to 1-factor: executive composite score. Seven tests in the NIH-EXAMINER is used to compute the composite score. -3 and +3 are the minimum and maximum values. Higher scores indicated better performance.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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