Cognitive Training With and Without tDCS to Improve Cognition in HIV

NCT ID: NCT02647645

Last Updated: 2021-06-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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HIV Mild Neurocognitive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cognitive Training

Cognitive training Sham tDCS

Group Type ACTIVE_COMPARATOR

Cognitive training

Intervention Type PROCEDURE

Computer delivered intervention designed to improve cognitive speed and executive functioning for a period of 20 minutes each for 6 sessions over two weeks.

Sham transcranial direct current stimulation

Intervention Type DEVICE

Direct current stimulation at a current of 1.5 mA with anode at F3 (left dorsolateral prefrontal cortex) and cathode at Fp2 (right frontal pole) for a period of one minute to simulate active treatment applied in 6 sessions over two weeks.

Cognitive Training with tDCS

Cognitive training Active tDCS

Group Type EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type DEVICE

Direct current stimulation at a current of 1.5 mA with anode at F3 (left dorsolateral prefrontal cortex) and cathode at Fp2 (right frontal pole) for a period of 20 minutes each for 6 sessions over two weeks simultaneously with cognitive training.

Cognitive training

Intervention Type PROCEDURE

Computer delivered intervention designed to improve cognitive speed and executive functioning for a period of 20 minutes each for 6 sessions over two weeks.

Interventions

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Transcranial direct current stimulation

Direct current stimulation at a current of 1.5 mA with anode at F3 (left dorsolateral prefrontal cortex) and cathode at Fp2 (right frontal pole) for a period of 20 minutes each for 6 sessions over two weeks simultaneously with cognitive training.

Intervention Type DEVICE

Cognitive training

Computer delivered intervention designed to improve cognitive speed and executive functioning for a period of 20 minutes each for 6 sessions over two weeks.

Intervention Type PROCEDURE

Sham transcranial direct current stimulation

Direct current stimulation at a current of 1.5 mA with anode at F3 (left dorsolateral prefrontal cortex) and cathode at Fp2 (right frontal pole) for a period of one minute to simulate active treatment applied in 6 sessions over two weeks.

Intervention Type DEVICE

Other Intervention Names

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tDCS Transcranial electric stimulation Brain training Sham tDCS Sham transcranial electric stimulation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nova Southeastern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raymond L Ownby, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

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NSU Psychiatry Research Office

Fort Lauderdale, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1203142F

Identifier Type: -

Identifier Source: org_study_id

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