Brain Aging in Veterans (BRAVE) Training: A Cognitive Training Pilot Trial in Older Veterans With Traumatic Brain Injury
2019年4月26日 更新者：Allison Kaup、San Francisco Veterans Affairs Medical Center
Cognitive Reserve and Training in Older Veterans With Traumatic Brain Injury: Study 2
The purpose of this study is to conduct a pilot trial investigating cognitive training in older Veterans with a history of traumatic brain injury (TBI) to assess training effects, acceptability of training to participants, and to explore whether other factors influence training effects.
研究概览
详细说明
A study of older Veterans (60-85 years old) who have 1) a history of repetitive mild TBI or at least one moderate TBI and 2) subjective cognitive complaints.
Participants will be randomized to one of three conditions for 4 weeks: Project:Evolution (EVO) multitask video game, EVO words video game, or an assessment only control condition.
Participants will complete assessment visits at baseline, post-intervention (1 month after baseline), and 3 months post-intervention (4 months after baseline).
研究类型
介入性
注册 (实际的)
89
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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California
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San Francisco、California、美国、94121
- San Francisco VA Medical Center
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Yountville、California、美国、94599
- Veterans Home of California
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Ages 60-85
- Have experienced more than one mild TBI or at least one moderate TBI over their lifetime
- Have current cognitive problems based on self-report
- Vision adequate to see test stimuli
- Hearing adequate to understand the examiner
- Fluent in English in order to understand task instructions
- Demonstrate capacity to consent to participate in research
- Mini-Mental Status Exam (MMSE) score ≥ 25
Exclusion Criteria:
- History of penetrating brain injury
- Active disabling neurological condition (e.g., stroke, brain tumor, multiple sclerosis)
- History of severe psychiatric illness (i.e., schizophrenia, bipolar disorder, schizoaffective disorder)
- Active drug use or active heavy alcohol use
- History of severe TBI
- History of a dementia diagnosis
- Individuals who are physically unable to use an iPad for 30 minutes at a time per day will be excluded, such as individuals with debilitating arthritis or tremor
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：仅评估
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实验性的：EVO multitask video game
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Participants will play a multitasking game for 4 weeks
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实验性的：EVO words video game
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Participants will play a word puzzle game for 4 weeks
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Acceptability based on participant ratings
大体时间：Acceptability ratings assessed post-intervention (1-month after baseline)
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Acceptability ratings assessed post-intervention (1-month after baseline)
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Participant adherence to game play
大体时间：Total adherence over the 4 week intervention phase
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Total adherence over the 4 week intervention phase
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Change in cognitive functioning based on neurocognitive test battery
大体时间：Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
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Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change in self-reported everyday cognitive functioning [Neuro-QOL (Quality of Life in Neurological Disorders) Cognitive Function inventory]
大体时间：Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
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Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
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Change in everyday functioning [University of California San Diego (UCSD) Performance Based Skills Assessment (UPSA)]
大体时间：Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
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Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
|
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Change in mood symptoms (Geriatric Depression Scale)
大体时间：Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
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Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
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Change in EVO performance (EVO Monitor)
大体时间：Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
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Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Allison Kaup, PhD、San Francisco Veterans Affairs Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年3月1日
初级完成 (实际的)
2019年1月1日
研究完成 (实际的)
2019年1月1日
研究注册日期
首次提交
2015年9月23日
首先提交符合 QC 标准的
2015年9月24日
首次发布 (估计)
2015年9月28日
研究记录更新
最后更新发布 (实际的)
2019年4月29日
上次提交的符合 QC 标准的更新
2019年4月26日
最后验证
2019年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.