Cognitive Reserve and Training in Older Veterans With Traumatic Brain Injury: Study 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 4
- 主要终点
- Acceptability based on participant ratings
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
EVO multitask video game
干预措施: EVO multitask video game (Behavioral)
EVO words video game
干预措施: EVO words video game (Behavioral)
Assessment Only
结局指标
主要结局
Acceptability based on participant ratings
时间窗: Acceptability ratings assessed post-intervention (1-month after baseline)
Participant adherence to game play
时间窗: Total adherence over the 4 week intervention phase
Change in cognitive functioning based on neurocognitive test battery
时间窗: Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline)
次要结局
- Change in self-reported everyday cognitive functioning [Neuro-QOL (Quality of Life in Neurological Disorders) Cognitive Function inventory](Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline))
- Change in everyday functioning [University of California San Diego (UCSD) Performance Based Skills Assessment (UPSA)](Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline))
- Change in mood symptoms (Geriatric Depression Scale)(Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline))
- Change in EVO performance (EVO Monitor)(Baseline, post-intervention (1-month after baseline), and 3-months post-intervention (4-months after baseline))
研究者
Allison Kaup
Clinical Research Psychologist
San Francisco Veterans Affairs Medical Center