Speed of Processing Training to Improve Cognitive Functioning and Driving Performance in Head and Neck Cancer Survivors
研究概览
详细说明
If participants agree to participate in the study by signing the informed consent, participants will be randomly assigned (similar to flipping a coin) to one of the two video game cognitive exercise groups. The only difference between these two groups is the intensity of training on reaction time to video game events.
participants will complete questionnaires (socio-demographic information, four short cognitive assessments) and a driving assessment using a high-fidelity motion-based virtual reality driving simulator in the UAB Driver Simulation Lab at baseline. After completing the baseline cognitive and driving evaluations, participants will receive an electronic tablet loaded with access to the assigned video game program and a workbook with instructions and explanations. A staff member will assist participants in logging in, demonstrate the video game cognitive exercises, and show participants how to play a trial game session.
At home, participants will complete 30-minute video game-based cognitive exercises twice weekly for 10 weeks (20 sessions, totaling 10 hours). The software will automatically record the actual session duration. One week after the baseline appointment, the staff will contact participants to address any technical problems. The staff will then contact participants monthly to monitor progress and answer study-related questions.
After the 10-week video game cognitive exercise program, participants will be invited to the UAB Driver Simulation Lab to complete the four short cognitive assessments and a driving assessment as participants did 10 weeks ago.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Hon Yuen
- 电话号码：12059346301
- 邮箱：yuen@uab.edu
研究联系人备份
- 姓名：Adrian Smith
- 电话号码：2059348931
- 邮箱：adrian02@uab.edu
学习地点
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama at Birmingham
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接触：
- Yuen
- 电话号码：2059345266
- 邮箱：honkeungyuen@gmail.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- confirmed HNC diagnosis
- aged ≥ 18 years of all racial, ethnic, and sex/gender categories
- ≥ 6 months post radiation or chemoradiation
- self-reported CRCI, defined as a score of ≥ 60 in the FACT-Cog Perceived Cognitive Impairment subscale
- thyroid-stimulating hormone levels within normal limits
- visual acuity of at least 20/40 using a Snellen eye chart
- functional peripheral vision as indicated by the confrontation field test
- functional hearing sufficient to engage in daily conversation in English for ≥ 15 minutes
- intact lower extremity function (Rapid Pace Walk test ≤ 9 sec)
- stable home internet
- sufficient English proficiency to read and understand informed consent materials
Exclusion Criteria:
- significant neurologic or psychiatric comorbidities, including psychotic disorders, bipolar disorders, Alzheimer's disease or related dementias, developmental disorders, seizure disorders, vestibular disorders, prior brain tumor or brain surgery, or poorly controlled metabolic disease
- current use of antipsychotic or mood-stabilizing medications due to potential effects on driving performance
- anticipated life expectancy of < 6 months based on physician prognosis.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 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 |
|---|---|
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实验性的：Speed of Processing Training
The training is the game-based cognitive exercises that involve the speed and accuracy of visual information processing and enhance divided attention between central and peripheral stimuli and among peripheral stimuli when distractors are present.
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The training is the game-based cognitive exercises that involve the speed and accuracy of visual information processing and enhance divided attention between central and peripheral stimuli and among peripheral stimuli when distractors are present.
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假比较器：Home-Based Sham Training
The sham condition includes five interactive video game activities that are self-paced, non-adaptive, and not designed to affect processing speed.
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The sham condition includes five interactive video game activities that are self-paced, non-adaptive, and not designed to affect processing speed.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Useful Field of View
大体时间：change from baseline in speed of processing at 10 weeks
|
Useful Field of View (UFOV) examines visual attention and memory that require rapid recognition and response to simultaneous demands in both the central and peripheral visual fields.
The test consists of four increasingly complex subtests.
In each subtest, stimulus presentations ranging from 17-500 milliseconds are displayed to determine the speed at which visual information is processed.
In each subtest, a double staircase method is used to determine the presentation speed at which participants correctly complete the task 75% of the time.
Lower scores (fewer milliseconds to correctly perceive the target) reflect faster SOP.
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change from baseline in speed of processing at 10 weeks
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合作者和调查者
调查人员
- 首席研究员：Hon Yuen、University of Alabama at Birmingham
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IRB-300017007
- UAB (其他标识符：UAB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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