HIV-related Mild Neurocognitive DisorderNCT03440840
Computer Training and Transcranial Direct Current Stimulation for Cognition in HIV
A study testing Transcranial Direct Current Stimulation (tDCS), Computer-based Cognitive Training and Watching Educational Videos in people with HIV-related Mild Neurocognitive Disorder, run by Nova Southeastern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV-related Mild Neurocognitive Disorder
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS), Computer-based Cognitive Training and Watching Educational Videos
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2018to 6 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated with antiretroviral medication for at least one month
- Meet criteria for Mild Neurocognitive Disorder
Who cannot join
- Seizure disorder
- Recent head injury or surgery
- Personal or family history of bipolar disorder;
- Some medications
- Left handedness
- HIV Dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
NSU Psychiatry Research Office
Fort Lauderdale, Florida, 33328
About this study
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.
Read the detailed description
In spite of advances in its treatment, persons with HIV continue to develop HIV-associated neurocognitive disorders (HAND) over time. HAND may be an even more significant problem in older persons (age 50+) with HIV who may experience age-related changes in cognition in addition to HAND. Because of HAND's impact on patients' functioning and quality of life, treatments are needed. Pharmacologic treatments have, in general, been ineffective and investigators have argued that computer delivered cognitive training may be an effective alternative. While results of small studies have been encouraging, the effect size of cognitive training may be small and of unclear practical importance. The nature of cognitive training programs, often building on laboratory measures of cognition, may reduce how inherently interesting (i.e., fun) they are, limiting their uptake outside of paid research studies. Others have argued for the use of computer games targeting psychomotor speed, problem solving, and visuospatial skills to improve cognitive function in older adults. Data support the utility of this approach, but again effect sizes may be small.
Transcranial direct current stimulation (tDCS) may be an effective way to enhance the effects of cognitive training. It involves the application of a small electric current (1-2 mA) to the head, inducing small currents within the brain that enhance cognitive training. Multiple studies have shown that tDCS enhances cognition, including attention and psychomotor speed. The investigators previously completed a single-blind pilot study of individuals with HIV-related mild neurocognitive disorder using a high-interest car racing game with or without tDCS. Results were encouraging in showing moderate to large effect sizes consistent with tDCS enhancement of cognitive function after six 20-minute training sessions over two weeks. Participants' subjective reports of cognitive difficulties supported observed effects on objective measures, and their mood improved. The intervention was acceptable to participants, many of whom stated they enjoyed it. Everyone indicated a willingness to participate in a similar study in the future.
In this study the investigators will expand on a pilot-tested training intervention with 120 individuals randomly assigned to an attention control condition or game-based cognitive training with either sham or active tDCS. The investigators will employ a battery of cognitive measures as well as self-report measures of mood, cognitive difficulties, and everyday functioning in order to evaluate the effects of study interventions.
Participants will first be screened for eligibility by telephone, and then scheduled for a visit during which their eligibility will be further assessed. Those who are eligible based on inclusion and exclusion criteria will complete a battery of measures of their cognitive and functional status. They will then complete six training sessions over a period of three weeks, and then once again complete the battery of assessments. Participants will then be asked to return one month after the post-training assessment to evaluate the persistence of training effects.
- Conditions
- HIV-related Mild Neurocognitive Disorder
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Computer-based Cognitive Training, Watching Educational Videos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Procedure or surgery
Also called tDCS
Application of a small electrical current (1-2 mA) across the head.
Computer-based Cognitive TrainingBehavioural
Also called Cognitive Training
Use of computer-delivered games or exercises with the goal of improving cognitive performance.
Watching Educational VideosBehavioural
Watching educational videos and answering questions about them
| Study group | Role | What they receive |
|---|---|---|
| Computer Training with active tDCS | Experimental | Participants randomized to this arm will receive computer-based cognitive training using a car racing game with active transcranial direct current stimulation (tDCS). Receives: Procedure: Transcranial Direct Current Stimulation (tDCS); Behavioral: Computer-based Cognitive Training |
| Computer Training with sham tDCS | Active comparator | Participants randomized to this arm will receive computer-based cognitive training using a car racing game with sham transcranial direct current stimulation (tDCS). Receives: Behavioral: Computer-based Cognitive Training |
| Computer Training with or without tDCS | Placebo comparator | Participants in this arm will watch educational videos as a comparator to computer training with the car racing game (watching educational videos). Receives: Procedure: Transcranial Direct Current Stimulation (tDCS); Behavioral: Watching Educational Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (3)
Functional Status
Participant performance on observed tasks of daily living. Participants completed the University of California--San Diego Performance Based Skills Assessment, version B. The person assessed is asked to complete several functional tasks, including pretending to make a call on a telephone to change a medical appointment and paying an electric bill by filling out a check. Scores on the first task range form 0 to 9, and from 0 to 11 on the second. These raw scores are then converted to create a final combined score that ranges from 0 to 100, with higher scores indicating a better performance.
Measured: 3 weeks
Participant Assessment of Own Functioning (PAOF)
Participant self-report of problems related to cognitive and sensory functioning on the Participant Assessment of Own Functioning (PAOF). This is a self-report measure of the frequency with which a person experiences difficulties with various mental and sensory tasks, such as remembering what is said to them, understanding or expressing themselves in language, and thinking about complex problems. The PAOF includes 33 items ranged from 0 to 5, allowing a total score from 0 to 165. A higher score on this measure means that the person is reporting greater frequency with some mental activities.
Measured: 3 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
Participant self-report of mood. The Center for Epidemiological Studies Depression scale (CES-D) is a self-report measure of symptoms of and related to depressed mood. It includes 20 items that are scored from 0 to 3 and summed for an overall score ranging from 0 to 60. Higher scores on this measure indicate that the person assessed is reporting a greater frequency or severity of depressive symptoms.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start16 Jan 2018
- Primary completion6 Nov 2019
- Study completion6 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-related Mild Neurocognitive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Ownby, M.D., Nova Southeastern University
- Investigators
- Raymond L Ownby, MD, PhD, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440840
- Sponsor's protocol ID
- AG056256
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2017
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the conclusion of the study, de-identified study data will be shared by the study principal investigator with interested individuals.
Publications
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.
PubMed 27822047Ownby 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.
PubMed 34867291
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Training and Transcranial Direct Current Stimulation for Cognition in HIV
- ClinicalTrials.gov ID
- NCT03440840
- Acronym / sponsor ID
- AG056256
- Conditions
- HIV-related Mild Neurocognitive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 6 Nov 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 18 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In spite of advances in its treatment, persons with HIV continue to develop HIV-associated neurocognitive disorders (HAND) over time. HAND may be an even more significant problem in older persons (age 50+) with HIV who may experience age-related changes in cognition in addition to HAND. Because of HAND's impact on patients' functioning and quality of life, treatments are needed. Pharmacologic treatments have, in general, been ineffective and investigators have argued that computer delivered cognitive training may be an effective alternative. While results of small studies have been encouraging, the effect size of cognitive training may be small and of unclear practical importance. The nature of cognitive training programs, often building on laboratory measures of cognition, may reduce how inherently interesting (i.e., fun) they are, limiting their uptake outside of paid research studies. Others have argued for the use of computer games targeting psychomotor speed, problem solving, and visuospatial skills to improve cognitive function in older adults. Data support the utility of this approach, but again effect sizes may be small.
Transcranial direct current stimulation (tDCS) may be an effective way to enhance the effects of cognitive training. It involves the application of a small electric current (1-2 mA) to the head, inducing small currents within the brain that enhance cognitive training. Multiple studies have shown that tDCS enhances cognition, including attention and psychomotor speed. The investigators previously completed a single-blind pilot study of individuals with HIV-related mild neurocognitive disorder using a high-interest car racing game with or without tDCS. Results were encouraging in showing moderate to large effect sizes consistent with tDCS enhancement of cognitive function after six 20-minute training sessions over two weeks. Participants' subjective reports of cognitive difficulties supported observed effects on objective measures, and their mood improved. The intervention was acceptable to participants, many of whom stated they enjoyed it. Everyone indicated a willingness to participate in a similar study in the future.
In this study the investigators will expand on a pilot-tested training intervention with 120 individuals randomly assigned to an attention control condition or game-based cognitive training with either sham or active tDCS. The investigators will employ a battery of cognitive measures as well as self-report measures of mood, cognitive difficulties, and everyday functioning in order to evaluate the effects of study interventions.
Participants will first be screened for eligibility by telephone, and then scheduled for a visit during which their eligibility will be further assessed. Those who are eligible based on inclusion and exclusion criteria will complete a battery of measures of their cognitive and functional status. They will then complete six training sessions over a period of three weeks, and then once again complete the battery of assessments. Participants will then be asked to return one month after the post-training assessment to evaluate the persistence of training effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized parallel group
| Arm | Type | Receives |
|---|---|---|
| Computer Training with active tDCS | Experimental | Procedure: Transcranial Direct Current Stimulation (tDCS), Behavioral: Computer-based Cognitive TrainingParticipants 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 comparator | Behavioral: Computer-based Cognitive TrainingParticipants 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 comparator | Procedure: Transcranial Direct Current Stimulation (tDCS), Behavioral: Watching Educational VideosParticipants in this arm will watch educational videos as a comparator to computer training with the car racing game (watching educational videos). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Treated with antiretroviral medication for at least one month
- Meet criteria for Mild Neurocognitive Disorder
Key exclusion criteria (6 listed)
- Seizure disorder
- Recent head injury or surgery
- Personal or family history of bipolar disorder;
- Some medications
- Left handedness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Also: tDCSApplication of a small electrical current (1-2 mA) across the head. | Procedure or surgery | Computer Training with active tDCS, Computer Training with or without tDCS |
| Computer-based Cognitive TrainingAlso: Cognitive TrainingUse of computer-delivered games or exercises with the goal of improving cognitive performance. | Behavioural | Computer Training with active tDCS, Computer Training with sham tDCS |
| Watching Educational VideosWatching educational videos and answering questions about them | Behavioural | Computer Training with or without tDCS |
Primary outcome
Psychomotor Speed
Time frame: 3 weeks
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 secondary outcomes
Functional Status
Time frame: 3 weeks
Participant Assessment of Own Functioning (PAOF)
Time frame: 3 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27822047Ownby 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.
- Results publication: PubMed 34867291Ownby 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.
- Individual participant dataSharing planned: Yes. After the conclusion of the study, de-identified study data will be shared by the study principal investigator with interested individuals.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond L Ownby, MD, PhD principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS), Computer-based Cognitive Training and Watching Educational Videos in people with HIV-related Mild Neurocognitive Disorder, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychomotor Speed (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03440840, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.