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Neural Correlates of Working Memory Training for HIV Patients

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ClinicalTrials.gov Identifier: NCT02602418
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of Maryland
Information provided by (Responsible Party):
Linda Chang, M.D., University of Maryland

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.

Condition or disease Intervention/treatment Phase
HIV Infection Other: Adaptive WM CogMed Training Other: Nonadaptive WM CogMed Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neural Correlates of Working Memory Training for HIV Patients: A Randomized Control Clinical Trial
Actual Study Start Date : September 2012
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Memory

Arm Intervention/treatment
Experimental: HIV Positive participants
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
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.

Other: Nonadaptive WM CogMed Training
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).

Seronegative particpiants
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
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.

Other: Nonadaptive WM CogMed Training
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 Measures :
  1. Changes in the Improvement Index on Cogmed™ [ Time Frame: 1 month after training, and 6 month after training completion ]
    This is generated by the computer training program based on the trained tasks.

  2. Changes in Performances on near transfer working memory tasks [ Time Frame: 1 month after training, and 6 month after training completion ]
    Verbal working memory and spatial working memory tasks

  3. Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures [ Time Frame: 1 month after training, and 6 month after training completion ]
    Brain activation during the performance of working memory and attention tasks


Secondary Outcome Measures :
  1. Changes in cognitive performance based on LIM homeobox transcription factor 1 alpha (LMX1A) genotypes (AA vs. GA/GG) [ Time Frame: 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

  2. Changes in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) [ Time Frame: 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.

  3. Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures based on LMX1A genotypes [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for HIV-infected participants :

  1. Men or women of any ethnicity, ages>18 years and able to provide informed consent,
  2. HIV seropositive (with documentation from medical records),
  3. 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 :

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

Exclusion criteria :

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602418


Contacts
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Contact: Linda Chang, MD 410-706-1036 Linda.Chang@umm.edu
Contact: Christine Cloak, PhD 410-706-1032 Christine.Cloak@umm.edu

Locations
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United States, Maryland
University of Maryland School of Medicine Recruiting
Baltimore, Maryland, United States, 21201
Contact: HuaJun Liang, PhD    410-706-1032    HuaJun.Liang@umm.edu   
Principal Investigator: Linda Chang, MD         
Sponsors and Collaborators
University of Hawaii
National Institute on Drug Abuse (NIDA)
University of Maryland
Investigators
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Principal Investigator: Linda Chang, MD University of Maryland Baltimiore

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Linda Chang, M.D., Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT02602418     History of Changes
Other Study ID Numbers: 4R01DA035659-04 ( U.S. NIH Grant/Contract )
4R01DA035659-04 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Linda Chang, M.D., University of Maryland:
Human Immunodeficiency Virus (HIV)
working memory training
brain function
functional magnetic resonance imaging (fMRI)

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases