Neural Correlates of Working Memory Training for HIV Patients

• Sponsor: University of Hawaii (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02602418
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), University of Maryland, Baltimore (Other)
• Enrollment: 180
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 92
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infection	Other: Adaptive WM CogMed Training; Other: Nonadaptive WM CogMed Training	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2012
• Anticipated Primary Completion Date: May 1, 2020
• Anticipated Study Completion Date: May 1, 2020

Arms and Interventions

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).
Other: 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).

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

3. 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

1. 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

2. 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.

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Linda Chang, MD, University of Maryland Baltimiore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Linda Chang, M.D., Professor, University of Maryland, College Park
• ClinicalTrials.gov Identifier: NCT02602418
• Other Study ID Numbers: 4R01DA035659-04; 4R01DA035659-04
• First Posted: Nov 11, 2015
• Last Update Posted: Oct 2, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Linda Chang, M.D., Professor, University of Maryland, College Park: Human Immunodeficiency Virus (HIV); working memory training; brain function; functional magnetic resonance imaging (fMRI)
• Additional relevant MeSH terms: HIV Infections

Study Results

No Results Posted as of Oct 2, 2019