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Clinical Trials/NCT02647645
NCT02647645
Terminated
Not Applicable

Cognitive Training With and Without tDCS to Improve Cognition in HIV

Nova Southeastern University1 site in 1 country21 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
Nova Southeastern University
Enrollment
21
Locations
1
Primary Endpoint
Working Memory: Participants' Rate of Improvement
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
May 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Working Memory: Participants' Rate of Improvement

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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