HIV-associated Neurocognitive Dysfunction
Conditions
Brief summary
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.
Interventions
Sponsors
Posit Science Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Participant is between 25-60 years of age 2. Participant is HIV positive 3. Participant has diagnosis of HIV-associated neurocognitive disorder (HAND), Mild Neurocognitive Disorder (MND) and HIV associated dementia (HAD) 4. Participant is fluent in English 5. Participant is able to use an iPad and have access to wireless internet connection 6. 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) 7. Participant is not enrolled in another research study 8. Participant does not have current or significant past history of substance abuse 9. Participant does not have severe depression or other chronic psychiatric disorder (eg. Schizophrenia or Bipolar Disorder)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Computerized Exercise-based Assessment | 3 months | The primary outcome measure is the useful field of view; change on this measure suggests underlying neural change, and has been shown to predict overall cognitive change. The exercise-based measure serves as a positive control for task learning. The investigators anticipate improvements in this assessment because participants have directly practiced these tasks, as well as tasks within related cognitive domains. The data are relevant because individuals failing to make progress on this assessment may represent a subpopulation not treatable with this program, and individuals making strong progress may represent a subpopulation particularly amenable to treatment with this program. This assessment will be performed on the first day of program use, approximately halfway through program use, and the last day of program use. All participants will access this assessment via Internet portal and study team member may access results via clinician portal. |
Countries
United States
Outcome results
None listed