Back to resultsCognitive Remediation for HIV-associated Neurocognitive Dysfunction (HAND)
Primary Purpose
HIV-associated Neurocognitive Dysfunction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized plasticity-based adaptive cognitive training
Sponsored by
About this trial
This is an interventional treatment trial for HIV-associated Neurocognitive Dysfunction
Eligibility 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)
Sites / Locations
- Posit Science Corporation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Computerized Plasticity-based Adaptive Cognitive Training
Arm Description
Outcomes
Primary Outcome Measures
Computerized Exercise-based Assessment
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02671526
First Posted
January 27, 2016
Last Updated
November 22, 2016
Sponsor
Posit Science Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02671526
Brief Title
Cognitive Remediation for HIV-associated Neurocognitive Dysfunction
Acronym
HAND
Official Title
Plasticity-based Adaptive Cognitive Remediation (PACR) for HIV-associated Neurocognitive Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Posit Science Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-associated Neurocognitive Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computerized Plasticity-based Adaptive Cognitive Training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Computerized plasticity-based adaptive cognitive training
Primary Outcome Measure Information:
Title
Computerized Exercise-based Assessment
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Van Vleet, Ph.D.
Organizational Affiliation
Posit Science Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Posit Science Corporation
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive Remediation for HIV-associated Neurocognitive Dysfunction
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