Neural Correlates of Working Memory Training for HIV Patients

NCT02602418 | Unknown DMC

• 1 other identifier: 4R01DA035659-04
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Changes in the Improvement Index on Cogmed™

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

  1 month after training, and 6 month after training completion

• Changes in Performances on near transfer working memory tasks

  Verbal working memory and spatial working memory tasks

  1 month after training, and 6 month after training completion

• Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures

  Brain activation during the performance of working memory and attention tasks

  1 month after training, and 6 month after training completion

Secondary Outcomes (3)

• 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

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

  1 month after training, and 6 month after training completion

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

  1 month after training, and 6 month after training completion

Study Arms (2)

HIV Positive participants

EXPERIMENTAL

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.

Other: Adaptive WM CogMed Training; Other: Nonadaptive WM CogMed Training

Seronegative particpiants

OTHER

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.

Other: Adaptive WM CogMed Training; Other: Nonadaptive WM CogMed Training

Interventions

Adaptive WM CogMed Training OTHER

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.

HIV Positive participants; Seronegative particpiants

Nonadaptive WM CogMed Training OTHER

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).

HIV Positive participants; Seronegative particpiants

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hawaii: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

• Chang L, Liang H, Ernst T, Cunningham E, Wang J, Baptiste J, Lohaugen GCC. LMX1A and APOE varepsilon Genotype Associations With Working Memory Training Effects in HIV and Non-HIV: A Randomized Controlled Trial. Neurol Neuroimmunol Neuroinflamm. 2026 Jan;13(1):e200519. doi: 10.1212/NXI.0000000000200519. Epub 2025 Dec 11.

  PMID: 41380114 DERIVED

• 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.

  PMID: 26833223 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Linda Chang, MD

  University of Maryland Baltimiore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 11, 2015
• Study Start: September 1, 2012
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: October 2, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)