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Neural Correlates of Working Memory Training for HIV Patients

Primary Purpose

HIV Infection

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Adaptive WM CogMed Training

Nonadaptive WM CogMed Training

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring Human Immunodeficiency Virus (HIV), working memory training, brain function, functional magnetic resonance imaging (fMRI)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for HIV-infected participants :

Men or women of any ethnicity, ages>18 years and able to provide informed consent,
HIV seropositive (with documentation from medical records),
Stable on an antiretroviral regimen for 6 months or will remain without antiretroviral treatment during the duration of the study.

Inclusion Criteria for Seronegative (SN) healthy participants :

Men or women of any ethnicity, ages > 18 years and able to give informed consent,
Seronegative for HIV

Exclusion criteria :

Confounding co-morbid psychiatric illness
Confounding neurological disorders
Abnormal screening laboratory tests (>2 SD) that might indicate a chronic medical condition (e.g. diabetes, severe cardiac, renal or liver disorders)
Medications that might influence outcome measures
Current or history of drug dependence within the past two years
Positive urine toxicology screen
Inability to read at an 8th grade level
Other contraindications for MR studies

Sites / Locations

University of Maryland School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

HIV Positive participants

Seronegative particpiants

Arm Description

Intervention; 90 HIV positive participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training.

Intervention; 90 seronegative participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training.

Outcomes

Primary Outcome Measures

Changes in the Improvement Index on Cogmed™

This is generated by the computer training program based on the trained tasks.

Changes in Performances on near transfer working memory tasks

Verbal working memory and spatial working memory tasks

Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures

Brain activation during the performance of working memory and attention tasks

Secondary Outcome Measures

Changes in cognitive performance based on LIM homeobox transcription factor 1 alpha (LMX1A) genotypes (AA vs. GA/GG)

Performance and improvements on cognitive tests may vary at baseline and after training based on LMX1A genotypes

Changes in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)

Improvement on BRIEF-A, a self-reported evaluation of the person's executive function during their activities of daily living.

Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures based on LMX1A genotypes

Brain activation during working memory performance may vary at baseline, 1-month or 6-months based on the different LMX1A genotypes

Full Information

NCT ID

NCT02602418

First Posted

November 5, 2015

Last Updated

October 1, 2019

Sponsor

University of Hawaii

Collaborators

National Institute on Drug Abuse (NIDA), University of Maryland, Baltimore

1. Study Identification

Unique Protocol Identification Number

NCT02602418

Brief Title

Neural Correlates of Working Memory Training for HIV Patients

Official Title

Neural Correlates of Working Memory Training for HIV Patients: A Randomized Control Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (Actual)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Hawaii

Collaborators

National Institute on Drug Abuse (NIDA), University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Despite potent combination antiretroviral therapy, cognitive (memory and concentration) problems continue to occur in up to 50% of HIV-infected individuals, especially in older infected individuals, and those who abuse alcohol, marijuana or psychostimulants. Since no effective treatments are available to these individuals with cognitive problems, conservative estimates indicate that the cost of care for these patients could double in the next two decades. To address this urgent problem, this study will use a comprehensive approach (cognitive tests, functional MRI and several biomarkers) to evaluate whether a novel computer-based training program would improve the brain function, especially working memory and attention, in HIV-infected and infected individuals.

Detailed Description

The Overall Goals are to perform a double blind placebo-controlled study using Cogmed™ to determine whether this adaptive WM training program will benefit HIV-infected individuals, and whether the investigators can identify individuals who might benefit most from the working memory (WM) training. Lastly, the investigators will explore how brain activation, neuroinflammation and cerebrospinal fluid (CSF) monoamine levels might be related to WM function before and after the training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection

Keywords

Human Immunodeficiency Virus (HIV), working memory training, brain function, functional magnetic resonance imaging (fMRI)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HIV Positive participants

Arm Type

Experimental

Arm Description

Intervention; 90 HIV positive participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training.

Arm Title

Seronegative particpiants

Arm Type

Other

Arm Description

Intervention; 90 seronegative participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training.

Intervention Type

Other

Intervention Name(s)

Adaptive WM CogMed Training

Intervention Description

12 different computerized visual and spatial Working Memory tasks will be presented at each sessoin. Each session will involve 8 of the 12 tasks, and each subject is required to complete 25 training sessions, 30-40 minutes per day, 4-5 days per week over a 5-8 week period (minimum 20 sessions). The tasks will become more difficult in an "adaptive" manner, which is hypothesized as optimal for learning and training effects.

Intervention Type

Other

Intervention Name(s)

Nonadaptive WM CogMed Training

Intervention Description

The same 12 computerized visual and spatial working memory tasks will be presented, but at a fixed ("non-adaptive") and low difficulty level. 5 sessions per week x 5 weeks fora total of 25 sessions (minimum 20 sessions).

Primary Outcome Measure Information:

Title

Changes in the Improvement Index on Cogmed™

Description

This is generated by the computer training program based on the trained tasks.

Time Frame

1 month after training, and 6 month after training completion

Title

Changes in Performances on near transfer working memory tasks

Description

Verbal working memory and spatial working memory tasks

Time Frame

1 month after training, and 6 month after training completion

Title

Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures

Description

Brain activation during the performance of working memory and attention tasks

Time Frame

1 month after training, and 6 month after training completion

Secondary Outcome Measure Information:

Title

Changes in cognitive performance based on LIM homeobox transcription factor 1 alpha (LMX1A) genotypes (AA vs. GA/GG)

Description

Performance and improvements on cognitive tests may vary at baseline and after training based on LMX1A genotypes

Time Frame

Baseline, 1 month after training, and 6 month after training completion

Title

Changes in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)

Description

Improvement on BRIEF-A, a self-reported evaluation of the person's executive function during their activities of daily living.

Time Frame

1 month after training, and 6 month after training completion

Title

Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures based on LMX1A genotypes

Description

Brain activation during working memory performance may vary at baseline, 1-month or 6-months based on the different LMX1A genotypes

Time Frame

1 month after training, and 6 month after training completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for HIV-infected participants : Men or women of any ethnicity, ages>18 years and able to provide informed consent, HIV seropositive (with documentation from medical records), Stable on an antiretroviral regimen for 6 months or will remain without antiretroviral treatment during the duration of the study. Inclusion Criteria for Seronegative (SN) healthy participants : Men or women of any ethnicity, ages > 18 years and able to give informed consent, Seronegative for HIV Exclusion criteria : Confounding co-morbid psychiatric illness Confounding neurological disorders Abnormal screening laboratory tests (>2 SD) that might indicate a chronic medical condition (e.g. diabetes, severe cardiac, renal or liver disorders) Medications that might influence outcome measures Current or history of drug dependence within the past two years Positive urine toxicology screen Inability to read at an 8th grade level Other contraindications for MR studies

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda Chang, MD

Organizational Affiliation

University of Maryland Baltimiore

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Maryland School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26833223

Citation

Chang L, Lohaugen GC, Douet V, Miller EN, Skranes J, Ernst T. Neural correlates of working memory training in HIV patients: study protocol for a randomized controlled trial. Trials. 2016 Feb 2;17:62. doi: 10.1186/s13063-016-1160-4.

Results Reference

derived

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Neural Correlates of Working Memory Training for HIV Patients

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