Neural Correlates of Working Memory Training for HIV Patients

Not Applicable

• Conditions: HIV Infection
• Interventions: Other: Adaptive WM CogMed Training; Other: Nonadaptive WM CogMed Training

• Registration Number: NCT02602418
• Lead Sponsor: University of Hawaii

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-02
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seronegative particpiants	Nonadaptive 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.
HIV Positive participants	Adaptive WM CogMed Training	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.
Seronegative particpiants	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.
HIV Positive participants	Nonadaptive WM CogMed Training	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.

Primary Outcome Measures

Name	Time	Method
Changes in Performances on near transfer working memory tasks	1 month after training, and 6 month after training completion	Verbal working memory and spatial working memory tasks
Changes in the Improvement Index on Cogmed™	1 month after training, and 6 month after training completion	This is generated by the computer training program based on the trained tasks.
Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures	1 month after training, and 6 month after training completion	Brain activation during the performance of working memory and attention tasks

Secondary Outcome Measures

Name	Time	Method
Changes in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)	1 month after training, and 6 month after training completion	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	1 month after training, and 6 month after training completion	Brain activation during working memory performance may vary at baseline, 1-month or 6-months based on the different LMX1A genotypes
Changes in cognitive performance based on LIM homeobox transcription factor 1 alpha (LMX1A) genotypes (AA vs. GA/GG)	Baseline, 1 month after training, and 6 month after training completion	Performance and improvements on cognitive tests may vary at baseline and after training based on LMX1A genotypes

Trial Locations

Locations (1)

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States