Clinical trial NCT02602418: Neural Correlates of Working Memory Training for HIV Patients
Official title: Neural Correlates of Working Memory Training for HIV Patients: A Randomized Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infection
Keywords: Human Immunodeficiency Virus (HIV)
working memory training
brain function
functional magnetic resonance imaging (fMRI)
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Maryland, Baltimore
First posted: 2015-11-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Changes in the Improvement Index on Cogmed™
timeFrame: 1 month after training, and 6 month after training completion
measure: Changes in Performances on near transfer working memory tasks
timeFrame: 1 month after training, and 6 month after training completion
measure: Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures
timeFrame: 1 month after training, and 6 month after training completion
Secondary outcomes:
measure: Changes in cognitive performance based on LIM homeobox transcription factor 1 alpha (LMX1A) genotypes (AA vs. GA/GG)
timeFrame: Baseline, 1 month after training, and 6 month after training completion
measure: Changes in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
timeFrame: 1 month after training, and 6 month after training completion
measure: Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures based on LMX1A genotypes
timeFrame: 1 month after training, and 6 month after training completion
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: University of Maryland Baltimiore
name: Linda Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.