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Cognitive Training With and Without tDCS to Improve Cognition in HIV

Primary Purpose

HIV, Mild Neurocognitive Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Cognitive training
Sham transcranial direct current stimulation
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NSU Psychiatry Research Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cognitive Training

Cognitive Training with tDCS

Arm Description

Cognitive training Sham tDCS

Cognitive training Active tDCS

Outcomes

Primary Outcome Measures

Working Memory: Participants' Rate of Improvement
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 Outcome Measures

Center for Epidemiological Studies Depression Scale (CES-D)
Participants' mood over the course of the study. We used the Center for Epidemiological Studies--Depression scale (CES-D) to measure mood. This measure includes 20 items that ask the person assessed to report his or her experience of mood symptoms over the past two weeks. Participants completed this measure before and after the study intervention. Scores can range from zero to 60, with most persons attaining a score of 15 or less. Higher scores are considered worse as they indicate more frequent or more severe mood symptoms.
Patient's Own Assessment of Function (PAOF)
Patient report of cognitive difficulties on the Patient Assessment of Own Functioning. This scale comprises 33 items describing problems in thinking, language, and memory. Participants rate each items according to how often they experience each problem on a six-point scale from "almost never" (score of 0) to "almost always" (score of 5). The participant's score is the sum of ratings on all items. The range of possible scores on each item is from 0 to 5, with most persons achieving a score of 1.5 or lower. Higher scores represent more frequent report of cognitive difficulties and thus are considered worse. The range of all possible scores for the full scale of 33 items is is 0 to 165.

Full Information

First Posted
January 5, 2016
Last Updated
June 10, 2021
Sponsor
Nova Southeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT02647645
Brief Title
Cognitive Training With and Without tDCS to Improve Cognition in HIV
Official Title
Cognitive Training With and Without tDCS to Improve Cognition in HIV
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Pilot study protocol terminated to begin expanded study.
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Southeastern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Mild Neurocognitive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Training
Arm Type
Active Comparator
Arm Description
Cognitive training Sham tDCS
Arm Title
Cognitive Training with tDCS
Arm Type
Experimental
Arm Description
Cognitive training Active tDCS
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Other Intervention Name(s)
tDCS, Transcranial electric stimulation
Intervention Description
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
Procedure
Intervention Name(s)
Cognitive training
Other Intervention Name(s)
Brain training
Intervention Description
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
Device
Intervention Name(s)
Sham transcranial direct current stimulation
Other Intervention Name(s)
Sham tDCS, Sham transcranial electric stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Working Memory: Participants' Rate of Improvement
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Center for Epidemiological Studies Depression Scale (CES-D)
Description
Participants' mood over the course of the study. We used the Center for Epidemiological Studies--Depression scale (CES-D) to measure mood. This measure includes 20 items that ask the person assessed to report his or her experience of mood symptoms over the past two weeks. Participants completed this measure before and after the study intervention. Scores can range from zero to 60, with most persons attaining a score of 15 or less. Higher scores are considered worse as they indicate more frequent or more severe mood symptoms.
Time Frame
3 weeks
Title
Patient's Own Assessment of Function (PAOF)
Description
Patient report of cognitive difficulties on the Patient Assessment of Own Functioning. This scale comprises 33 items describing problems in thinking, language, and memory. Participants rate each items according to how often they experience each problem on a six-point scale from "almost never" (score of 0) to "almost always" (score of 5). The participant's score is the sum of ratings on all items. The range of possible scores on each item is from 0 to 5, with most persons achieving a score of 1.5 or lower. Higher scores represent more frequent report of cognitive difficulties and thus are considered worse. The range of all possible scores for the full scale of 33 items is is 0 to 165.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond L Ownby, MD, PhD
Organizational Affiliation
Nova Southeastern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NSU Psychiatry Research Office
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33328
Country
United States

12. IPD Sharing Statement

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Cognitive Training With and Without tDCS to Improve Cognition in HIV

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