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OpenTrials
Completed

NCT Number: NCT02671526

Cognitive Remediation for HIV-associated Neurocognitive Dysfunction

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.

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Key information

Conditions

HIV-associated Neurocognitive Dysfunction

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Posit Science Corporation

San Francisco, California, 94108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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)

Treatment and study plan

Computerized plasticity-based adaptive cognitive training

Other

Primary outcomes

  1. Computerized Exercise-based Assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Posit Science Corporation

Industry

Registry information

Official study title

Plasticity-based Adaptive Cognitive Remediation (PACR) for HIV-associated Neurocognitive Dysfunction

Acronym: HAND

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2016
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.