Neural Correlates of Working Memory Training for HIV Patients

University of Hawaii

Status: Unknown

Conditions: HIV Infection

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02602418

4R01DA035659-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

180 participants in 2 patient groups

HIV Positive participants

Experimental group

Description:

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.

Treatment:

Other: Adaptive WM CogMed Training

Other: Nonadaptive WM CogMed Training

Seronegative particpiants

Other group

Description:

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.

Treatment:

Other: Adaptive WM CogMed Training

Other: Nonadaptive WM CogMed Training