Computer Training and Transcranial Direct Current Stimulation for Cognition in HIV

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-16

Study Completion Date

2019-11-06

Brief Summary

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This study investigates the effectiveness of computer-based cognitive training with or without transcranial direct current stimulation (tDCS) in improving the functioning of older individuals with HIV-related cognitive dysfunction.

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Detailed Description

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In spite of advances in its treatment, persons with HIV continue to develop HIV-associated neurocognitive disorders (HAND) over time. HAND may be an even more significant problem in older persons (age 50+) with HIV who may experience age-related changes in cognition in addition to HAND. Because of HAND's impact on patients' functioning and quality of life, treatments are needed. Pharmacologic treatments have, in general, been ineffective and investigators have argued that computer delivered cognitive training may be an effective alternative. While results of small studies have been encouraging, the effect size of cognitive training may be small and of unclear practical importance. The nature of cognitive training programs, often building on laboratory measures of cognition, may reduce how inherently interesting (i.e., fun) they are, limiting their uptake outside of paid research studies. Others have argued for the use of computer games targeting psychomotor speed, problem solving, and visuospatial skills to improve cognitive function in older adults. Data support the utility of this approach, but again effect sizes may be small.

Transcranial direct current stimulation (tDCS) may be an effective way to enhance the effects of cognitive training. It involves the application of a small electric current (1-2 mA) to the head, inducing small currents within the brain that enhance cognitive training. Multiple studies have shown that tDCS enhances cognition, including attention and psychomotor speed. The investigators previously completed a single-blind pilot study of individuals with HIV-related mild neurocognitive disorder using a high-interest car racing game with or without tDCS. Results were encouraging in showing moderate to large effect sizes consistent with tDCS enhancement of cognitive function after six 20-minute training sessions over two weeks. Participants' subjective reports of cognitive difficulties supported observed effects on objective measures, and their mood improved. The intervention was acceptable to participants, many of whom stated they enjoyed it. Everyone indicated a willingness to participate in a similar study in the future.

In this study the investigators will expand on a pilot-tested training intervention with 120 individuals randomly assigned to an attention control condition or game-based cognitive training with either sham or active tDCS. The investigators will employ a battery of cognitive measures as well as self-report measures of mood, cognitive difficulties, and everyday functioning in order to evaluate the effects of study interventions.

Participants will first be screened for eligibility by telephone, and then scheduled for a visit during which their eligibility will be further assessed. Those who are eligible based on inclusion and exclusion criteria will complete a battery of measures of their cognitive and functional status. They will then complete six training sessions over a period of three weeks, and then once again complete the battery of assessments. Participants will then be asked to return one month after the post-training assessment to evaluate the persistence of training effects.

Conditions

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HIV-related Mild Neurocognitive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized parallel group

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Individuals will receive either active or sham tDCS. The outcomes assessor will be blind to treatment group assignment.

Study Groups

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Computer Training with active tDCS

Participants randomized to this arm will receive computer-based cognitive training using a car racing game with active transcranial direct current stimulation (tDCS).

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type PROCEDURE

Application of a small electrical current (1-2 mA) across the head.

Computer-based Cognitive Training

Intervention Type BEHAVIORAL

Use of computer-delivered games or exercises with the goal of improving cognitive performance.

Computer Training with sham tDCS

Participants randomized to this arm will receive computer-based cognitive training using a car racing game with sham transcranial direct current stimulation (tDCS).

Group Type ACTIVE_COMPARATOR

Computer-based Cognitive Training

Intervention Type BEHAVIORAL

Use of computer-delivered games or exercises with the goal of improving cognitive performance.

Computer Training with or without tDCS

Participants in this arm will watch educational videos as a comparator to computer training with the car racing game (watching educational videos).

Group Type PLACEBO_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type PROCEDURE

Application of a small electrical current (1-2 mA) across the head.

Watching Educational Videos

Intervention Type BEHAVIORAL

Watching educational videos and answering questions about them

Interventions

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Transcranial Direct Current Stimulation (tDCS)

Application of a small electrical current (1-2 mA) across the head.

Intervention Type PROCEDURE

Computer-based Cognitive Training

Use of computer-delivered games or exercises with the goal of improving cognitive performance.

Intervention Type BEHAVIORAL

Watching Educational Videos

Watching educational videos and answering questions about them

Intervention Type BEHAVIORAL

Other Intervention Names

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tDCS Cognitive Training

Eligibility Criteria

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Inclusion Criteria

* Treated with antiretroviral medication for at least one month
* Meet criteria for Mild Neurocognitive Disorder

Exclusion Criteria

* Seizure disorder
* Recent head injury or surgery
* Personal or family history of bipolar disorder;
* Some medications
* Left handedness
* HIV Dementia

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No