Neural Correlates of Working Memory Training for HIV Patients: A Randomized Control Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Changes in Performances on near transfer working memory tasks
研究概览
简要总结
Despite potent combination antiretroviral therapy, cognitive (memory and concentration) problems continue to occur in up to 50% of HIV-infected individuals, especially in older infected individuals, and those who abuse alcohol, marijuana or psychostimulants. Since no effective treatments are available to these individuals with cognitive problems, conservative estimates indicate that the cost of care for these patients could double in the next two decades. To address this urgent problem, this study will use a comprehensive approach (cognitive tests, functional MRI and several biomarkers) to evaluate whether a novel computer-based training program would improve the brain function, especially working memory and attention, in HIV-infected and infected individuals.
详细描述
The Overall Goals are to perform a double blind placebo-controlled study using Cogmed™ to determine whether this adaptive WM training program will benefit HIV-infected individuals, and whether the investigators can identify individuals who might benefit most from the working memory (WM) training. Lastly, the investigators will explore how brain activation, neuroinflammation and cerebrospinal fluid (CSF) monoamine levels might be related to WM function before and after the training.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
HIV Positive participants
Intervention; 90 HIV positive participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training.
干预措施: Adaptive WM CogMed Training (Other)
HIV Positive participants
Intervention; 90 HIV positive participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training.
干预措施: Nonadaptive WM CogMed Training (Other)
Seronegative particpiants
Intervention; 90 seronegative participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training.
干预措施: Adaptive WM CogMed Training (Other)
Seronegative particpiants
Intervention; 90 seronegative participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training.
干预措施: Nonadaptive WM CogMed Training (Other)
结局指标
主要结局
Changes in Performances on near transfer working memory tasks
时间窗: 1 month after training, and 6 month after training completion
Verbal working memory and spatial working memory tasks
Changes in the Improvement Index on Cogmed™
时间窗: 1 month after training, and 6 month after training completion
This is generated by the computer training program based on the trained tasks.
Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures
时间窗: 1 month after training, and 6 month after training completion
Brain activation during the performance of working memory and attention tasks
次要结局
- Changes in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(1 month after training, and 6 month after training completion)
- Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures based on LMX1A genotypes(1 month after training, and 6 month after training completion)
- Changes in cognitive performance based on LIM homeobox transcription factor 1 alpha (LMX1A) genotypes (AA vs. GA/GG)(Baseline, 1 month after training, and 6 month after training completion)
研究者
Linda Chang, M.D.
Professor
University of Maryland, College Park