Computer Training and Transcranial Direct Current Stimulation for Cognition in HIV

November 22, 2022 updated by: Raymond Ownby, M.D., Nova Southeastern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33328
        • NSU Psychiatry Research Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Procedure: Transcranial Direct Current Stimulation (tDCS)
Application of a small electrical current (1-2 mA) across the head.
Other Names:
  • tDCS
Behavioral: Computer-based Cognitive Training
Use of computer-delivered games or exercises with the goal of improving cognitive performance.
Other Names:
  • Cognitive Training
Active Comparator: 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).
Behavioral: Computer-based Cognitive Training
Use of computer-delivered games or exercises with the goal of improving cognitive performance.
Other Names:
  • Cognitive Training
Placebo Comparator: 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).
Procedure: Transcranial Direct Current Stimulation (tDCS)
Application of a small electrical current (1-2 mA) across the head.
Other Names:
  • tDCS
Behavioral: Watching Educational Videos
Watching educational videos and answering questions about them

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychomotor Speed
Time Frame: 3 weeks
Ability of the participant to attend to and use complex stimuli while making a motor response. The Coding subtest of the Wechsler Adult Intelligence Scale, 4th ed. (WAIS-IV) asks that the person assessed insert small geometric drawings with pencil on paper according to a key at the top of the page. One figure corresponds to the numeral 1, another to 2, and so on. The persons is asked to work as quickly as they can, and given a specific period in which to complete the task. Raw scores are the number of boxes correctly filled in during the time allowed and can range from 0 to 155, with higher scores indicating a better performance.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Status
Time Frame: 3 weeks
Participant performance on observed tasks of daily living. Participants completed the University of California--San Diego Performance Based Skills Assessment, version B. The person assessed is asked to complete several functional tasks, including pretending to make a call on a telephone to change a medical appointment and paying an electric bill by filling out a check. Scores on the first task range form 0 to 9, and from 0 to 11 on the second. These raw scores are then converted to create a final combined score that ranges from 0 to 100, with higher scores indicating a better performance.
3 weeks
Participant Assessment of Own Functioning (PAOF)
Time Frame: 3 weeks
Participant self-report of problems related to cognitive and sensory functioning on the Participant Assessment of Own Functioning (PAOF). This is a self-report measure of the frequency with which a person experiences difficulties with various mental and sensory tasks, such as remembering what is said to them, understanding or expressing themselves in language, and thinking about complex problems. The PAOF includes 33 items ranged from 0 to 5, allowing a total score from 0 to 165. A higher score on this measure means that the person is reporting greater frequency with some mental activities.
3 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame: 3 weeks
Participant self-report of mood. The Center for Epidemiological Studies Depression scale (CES-D) is a self-report measure of symptoms of and related to depressed mood. It includes 20 items that are scored from 0 to 3 and summed for an overall score ranging from 0 to 60. Higher scores on this measure indicate that the person assessed is reporting a greater frequency or severity of depressive symptoms.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Investigators

  • Principal Investigator: Raymond L Ownby, MD, PhD, Nova Southeastern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2018

Primary Completion (Actual)

November 6, 2019

Study Completion (Actual)

November 6, 2019

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

February 19, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG056256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the conclusion of the study, de-identified study data will be shared by the study principal investigator with interested individuals.

IPD Sharing Time Frame

After study conclusion.

IPD Sharing Access Criteria

Researchers who indicate an interest in using the data for legitimate purposes.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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