Neural Correlates of Working Memory Training for HIV Patients

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02602418
• Other study ID #: 4R01DA035659-04
• Secondary ID: 4R01DA035659-04
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2012
• Est. completion date: May 2020

Study information

• Verified date: October 2019
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Hawaii	National Institute on Drug Abuse (NIDA), University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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	Baseline, 1 month after training, and 6 month after training completion
Secondary	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.	1 month after training, and 6 month after training completion
Secondary	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	1 month after training, and 6 month after training completion