Computerized Cognitive Treatment of Vigilance Deficits in Individuals With Acquired Brain Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Attention and Memory
研究概览
简要总结
Problems with attention are a common and debilitating consequence of brain injury. Studies show that poor attention is the number one predictor of poor cognitive functioning one year post-injury. This is due to the fact that attention is a necessary component of more complex cognitive functions such as learning & memory, multi-tasking and problem solving. In many cases, individuals may exhibit problems with spatial attention known as 'hemi-spatial neglect syndrome' or simply 'neglect'. Many studies now show that the processing machinery of the brain is plastic and remodeled throughout life by learning and experience, enabling the strengthening of cognitive skills or abilities. The investigators own research has shown that brief, daily computerized cognitive training that is sufficiently challenging, goal-directed and adaptive enables intact brain structures to restore balance in attention and compensate for disruptions in cognitive functioning.
详细描述
Participants will first engage in an assessment process to determine current level of cognitive function. This process consists of paper-pencil surveys and computerized tests. Following the assessment process, participants will engage in Internet browser-delivered training sessions conducted on any internet-accessible computer. These trainings can be done up to 7 times a week (once a day) or at participant's convenience (the investigators recommend 4-5 times a week). Following the completion of training, participant's cognitive function will be re-assessed. Participation is voluntary and participants may withdraw from the study at any time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must 21 years or older and not pregnant as indicated by self-report
- •Participant must be fluent in English (indicated by self-report)
- •Participant must be able to engage with computerized cognitive tasks as indicated by investigator's opinion after 30 minutes of computer interaction
- •Participants should have no history of chronic psychiatric or neurological condition (preceding the current insult) as indicated by self-report
- •Normal vision (or corrected to normal vision) as indicated by self-report
- •Participants must be willing to commit to the time requirements of the study as evidenced by written, informed consent.
- •Evidence of hemispatial neglect and/ or vigilance decline on at least one standard measure (e.g., A-SCAN).
排除标准
- •Participants report or present a hand tremor that prevents the use of a computer mouse or keyboard, in the opinion of the evaluating Principal or Sub-Investigator.
- •Unable to perform neuropsychological evaluations in the opinion of the evaluating Principal or Sub-Investigator.
- •In the opinion of the consenting staff person, the participant cannot comprehend, follow instructions, or is incapable of providing written, informed consent.
- •In the opinion of the consenting staff person, participant is not capable of giving informed consent and does not have a Legal Authorized Representative.
- •History of recurrent psychiatric impairment as indicated by self-report.
- •History of drug or alcohol abuse as indicated by self-report.
- •History of significant medical diseases or multiple neurological events of the head as indicated by self-report.
研究组 & 干预措施
TAPAT
Computerized Tonic and Phasic Attention training consisting of visual, auditory, and spatial stimuli that requires sustained attention (24 minutes). Training is followed by a computerized cognitive exercise (12 minutes).
干预措施: Tonic and Phasic Attention Training (Behavioral)
Active Comparator
Computerized conventional board-games that lack the therapeutic effect of the TAPAT exercises. Active control has stimulus parameters similar to the TAPAT exercises (eg. stimuli is presented on the computer, participant responses are collected, session time and improvement is measured).
干预措施: Active Comparator (Behavioral)
结局指标
主要结局
Attention and Memory
时间窗: 6 months
Percent change on standardized measures of attention and executive function (all participants) using the ASCAN, Attentional Blink, Attention Capture Task, Landmark task, Conjunction Search task, SART, Verbal Fluency, CVLT-II, D-KEFS Stroop, and LNS assessments.
次要结局
未报告次要终点