Cognitive Remediation for HIV-associated Neurocognitive Dysfunction
NCT02671526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2016-11-23
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.
Conditions
- HIV-associated Neurocognitive Dysfunction
Interventions
- OTHER
-
Computerized plasticity-based adaptive cognitive training
Sponsors & Collaborators
-
Posit Science Corporation
lead INDUSTRY
Principal Investigators
-
Thomas Van Vleet, Ph.D. · Posit Science Corporation
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 25 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-31
- Primary Completion
- 2016-11-30
- Completion
- 2016-11-30
Countries
- United States
Study Locations
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