Cognitive Remediation for HIV-associated Neurocognitive Dysfunction (HAND)

Posit Science

Status

Completed

Conditions

HIV-associated Neurocognitive Dysfunction

Treatments

Other: Computerized plasticity-based adaptive cognitive training

Study type

Interventional

Funder types

Industry

Identifiers

NCT02671526

PSC-1005-14

Details and patient eligibility

About

This study is a validation study to document the acceptability of the revised Plasticity-based Adaptive Cognitive Remediation (PACR) program to patients with HIV-associated Neurocognitive Dysfunction (HAND). The primary objective of this study is to evaluate the effects of the revised PACR program on the cognitive abilities (e.g., attention, executive function), functional status and quality of life of individuals diagnosed with HAND. The secondary objective of the study is to collect relevant data to support a pre-investigational device exemption (IDE) submission to the FDA required before the pivotal randomized, controlled trial planned for Phase II.

Enrollment

19 patients

Sex

All

Ages

25 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Participant is between 25-60 years of age
Participant is HIV positive
Participant has diagnosis of HIV-associated neurocognitive disorder (HAND), Mild Neurocognitive Disorder (MND) and HIV associated dementia (HAD)
Participant is fluent in English
Participant is able to use an iPad and have access to wireless internet connection
Participant does not have a history of other conditions (other that from HAND), including mental illness, cancer, or other neurological conditions (multiple sclerosis, seizure disorder)
Participant is not enrolled in another research study
Participant does not have current or significant past history of substance abuse
Participant does not have severe depression or other chronic psychiatric disorder (eg. Schizophrenia or Bipolar Disorder)