Computer Training and Transcranial Direct Current Stimulation for Cognition in HIV
1 other identifier
interventional
46
1 country
1
Brief Summary
This study investigates the effectiveness of computer-based cognitive training with or without transcranial direct current stimulation (tDCS) in improving the functioning of older individuals with HIV-related cognitive dysfunction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2017
CompletedStudy Start
First participant enrolled
January 16, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2019
CompletedResults Posted
Study results publicly available
September 18, 2023
CompletedSeptember 18, 2023
November 1, 2022
1.8 years
November 8, 2017
April 7, 2022
November 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Psychomotor Speed
Ability of the participant to attend to and use complex stimuli while making a motor response. The Coding subtest of the Wechsler Adult Intelligence Scale, 4th ed. (WAIS-IV) asks that the person assessed insert small geometric drawings with pencil on paper according to a key at the top of the page. One figure corresponds to the numeral 1, another to 2, and so on. The persons is asked to work as quickly as they can, and given a specific period in which to complete the task. Raw scores are the number of boxes correctly filled in during the time allowed and can range from 0 to 155, with higher scores indicating a better performance.
3 weeks
Secondary Outcomes (3)
Functional Status
3 weeks
Participant Assessment of Own Functioning (PAOF)
3 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
3 weeks
Study Arms (3)
Computer Training with active tDCS
EXPERIMENTALParticipants randomized to this arm will receive computer-based cognitive training using a car racing game with active transcranial direct current stimulation (tDCS).
Computer Training with sham tDCS
ACTIVE COMPARATORParticipants randomized to this arm will receive computer-based cognitive training using a car racing game with sham transcranial direct current stimulation (tDCS).
Computer Training with or without tDCS
PLACEBO COMPARATORParticipants in this arm will watch educational videos as a comparator to computer training with the car racing game (watching educational videos).
Interventions
Application of a small electrical current (1-2 mA) across the head.
Use of computer-delivered games or exercises with the goal of improving cognitive performance.
Watching educational videos and answering questions about them
Eligibility Criteria
You may qualify if:
- Treated with antiretroviral medication for at least one month
- Meet criteria for Mild Neurocognitive Disorder
You may not qualify if:
- Seizure disorder
- Recent head injury or surgery
- Personal or family history of bipolar disorder;
- Some medications
- Left handedness
- HIV Dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NSU Psychiatry Research Office
Fort Lauderdale, Florida, 33328, United States
Related Publications (2)
Ownby RL, Acevedo A. A pilot study of cognitive training with and without transcranial direct current stimulation to improve cognition in older persons with HIV-related cognitive impairment. Neuropsychiatr Dis Treat. 2016 Oct 25;12:2745-2754. doi: 10.2147/NDT.S120282. eCollection 2016.
PMID: 27822047BACKGROUNDOwnby RL, Kim J. Computer-Delivered Cognitive Training and Transcranial Direct Current Stimulation in Patients With HIV-Associated Neurocognitive Disorder: A Randomized Trial. Front Aging Neurosci. 2021 Nov 15;13:766311. doi: 10.3389/fnagi.2021.766311. eCollection 2021.
PMID: 34867291RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
In this trial, we were only able to recruit 46 participants, of whom 44 completed the study. The original plan was to recruit 120 individuals, of whom 90 would complete the study. The sample size is thus substantially smaller than planned.
Results Point of Contact
- Title
- Raymond L Ownby, MD, PhD
- Organization
- Nova Southeastern University
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond L Ownby, MD, PhD
Nova Southeastern University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Individuals will receive either active or sham tDCS. The outcomes assessor will be blind to treatment group assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair
Study Record Dates
First Submitted
November 8, 2017
First Posted
February 22, 2018
Study Start
January 16, 2018
Primary Completion
November 6, 2019
Study Completion
November 6, 2019
Last Updated
September 18, 2023
Results First Posted
September 18, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- After study conclusion.
- Access Criteria
- Researchers who indicate an interest in using the data for legitimate purposes.
After the conclusion of the study, de-identified study data will be shared by the study principal investigator with interested individuals.