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临床试验/NCT02647645
NCT02647645终止不适用

Cognitive Training With and Without tDCS to Improve Cognition in HIV

Nova Southeastern University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
21
试验地点
2
主要终点
Working Memory: Participants' Rate of Improvement

研究概览

简要总结

The purpose of this study is to develop pilot data on the potential efficacy of computer-based cognitive training or the combination of computer-based cognitive training with transcranial direct current stimulation (tDCS) in improving cognitive function in persons with HIV-related mild neurocognitive disorder (MND).

详细描述

The purpose of this study is to develop pilot data on the potential efficacy of computer-based cognitive training or the combination of computer-based cognitive training with transcranial direct current stimulation (tDCS) in improving cognitive function in persons with HIV-related mild neurocognitive disorder (MND). tDCS is a noninvasive brain stimulation technique in which a small direct current (1-2 mA) is applied to the scalp during a cognitive or motor activity, inducing a very small current that affects specific neural circuits related to the site at which electrodes are placed. tDCS has been judged safe and has shown significant treatment effects in studies with other populations, but has not been extensively studied in individuals with HIV infection. tDCS has been shown to facilitate learning in a number of studies, suggesting that it may improve or enhance learning in those with cognitive problems. As HIV infection is associated with decrements in a number of cognitive skills, including working memory, executive functions, and psychomotor speed that are related to individuals' functional status and medication adherence, the demonstration of a technique to enhance the effects of cognitive training in this population would have substantial clinical benefits as well as scientific value.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Fluent in English
  • Meets Frascati criteria for mild neurocognitive disorder

排除标准

  • Left handed
  • Presence of dementia
  • Use of specific psychotropic medications including antidepressants, antipsychotics, and sleep-promoting medications

结局指标

主要结局

Working Memory: Participants' Rate of Improvement

时间窗: 3 weeks

Participants' rate of improvement on a verbal working memory task. Participants completed a battery of cognitive measures administered by an evaluator blind to treatment assignment. We used the Digits Backward trial of the Digit Span subtest of the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV; Pearson Assessment) to measure working memory. We used raw scores for analyses. These are the largest number of digits the participant could remember and repeat in reverse order. Possible range of scores is from zero to 10. Normal persons typically remember from 5 to 7 digits. Higher scores are considered better. Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, helper T cell count, and log viral load as covariates.

次要结局

  • Center for Epidemiological Studies Depression Scale (CES-D)(3 weeks)
  • Patient's Own Assessment of Function (PAOF)(3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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