An interventional study of Transcranial Direct Current Stimulation (tDCS) and Computer-based Cognitive Training in HIV-related Mild Neurocognitive Disorder, sponsored by Nova Southeastern University. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by Nova Southeastern University · Not applicable, Interventional, and Treatment
Among 76 studies in Neurocognitive Disorders with a site in United States — 17 open to participants now, 21 under way, 1 of them phase 3. Neurocognitive Disorders · United States.
Among the 76 studies in Neurocognitive Disorders with a site in United States, this one is the 41st largest by enrollment of the 60 interventional ones that give a count, is one of 7 that started in 2018, is one of 31 with no phase, and was the 23rd registered.
274 studies on the registry are indexed under Neurocognitive Disorders; 90 are open to participants now.
Browse Neurocognitive Disorders studies →17 of the 76 studies in Neurocognitive Disorders with a site in United States are open now. Recruiting first, the newest first:
University of Pittsburgh · Sites in United States
Ages 65+
Eli Lilly and Company · Sites in United States, Japan, Korea, Republic of and 1 more country
Ages 55–85
Texas Tech University · Sites in United States
Ages 18+ · Healthy volunteers
Medical University of South Carolina · Sites in United States
Ages 60–85
MapLight Therapeutics · Sites in United States, Argentina, Bulgaria and 12 more countries
Ages 55–90
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 60 Neurocognitive Disorders studies recruiting now, 37 (62%) set no upper age limit and 2 (3%) stop at 75 or younger; 4 take children under 18; 17 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
76 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 16 · Phase 3 6 · Phase 4 2
First in 2003; this study’s year is marked. 7 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 46 is below the median of 80 across 175 interventional studies indexed under Neurocognitive Disorders.
Median enrollment 80 across the 60 interventional studies, 48 across the 15 observational. Of the 48 that completed or were terminated, 23 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
19 of 76 have an industry lead sponsor. The 10 most frequent:
Nova Southeastern University is the lead sponsor of 80 studies on the registry; 18 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Nova Southeastern University has 2 studies filed under Neurocognitive Disorders — fewer than ten, so there is no comparison to draw.
7 of the studies in Neurocognitive Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06718140Medical University of South CarolinatFUS for Memory in mNCD and Healthy Adults | 2026-12-01 |
| NCT06036095Oregon Health and Science UniversityTotal Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study | 2027-03-15 |
| NCT05457725University of FloridaModulating Neurocognitive Processes of Learning to Trust and Distrust in Aging | 2027-04-30 |
| NCT05929703University of MichiganEvaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders | 2027-05 |
| NCT06042413University of PittsburghPrediction and Prevention of Postoperative Mortality and Morbidity | 2027-10 |
Add all 7 to your calendar (.ics) → With an account.
Among the 76 studies in Neurocognitive Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with active transcranial direct current stimulation (tDCS).
Procedure: Transcranial Direct Current Stimulation (tDCS) · Behavioral: Computer-based Cognitive Training
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with sham transcranial direct current stimulation (tDCS).
Behavioral: Computer-based Cognitive Training
Participants in this arm will watch educational videos as a comparator to computer training with the car racing game (watching educational videos).
Procedure: Transcranial Direct Current Stimulation (tDCS) · Behavioral: Watching Educational Videos
Application of a small electrical current (1-2 mA) across the head.
Also known as: tDCS
Use of computer-delivered games or exercises with the goal of improving cognitive performance.
Also known as: Cognitive Training
Watching educational videos and answering questions about them
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.
Time frame: 3 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 weeks
| Milestone | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS |
|---|---|---|---|
| Started | 16 | 15 | 15 |
| Completed | 15 | 14 | 15 |
| Not completed | 1 | 1 | 0 |
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.
| score on a scale | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS |
|---|---|---|---|
| Psychomotor Speed | 54.2 (43.2 to 65.2) | 60.4 (49.4 to 71.4) | 53.4 (42.6 to 64.2) |
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.
| score on a scale | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS |
|---|---|---|---|
| Functional Status | 84.6 (74.8 to 94.5) | 82.8 (72.9 to 92.6) | 84.4 (74.8 to 94.0) |
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.
| score on a scale | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS |
|---|---|---|---|
| Participant Assessment of Own Functioning (PAOF) | 7.98 (6.27 to 9.69) | 7.73 (6.01 to 9.44) | 7.86 (6.19 to 9.52) |
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.
| score on a scale | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS |
|---|---|---|---|
| Center for Epidemiological Studies Depression Scale (CES-D) | 16.5 (9.53 to 23.50) | 16.6 (9.59 to 23.70) | 16.3 (9.54 to 23.10) |
Collected over 7 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Computer Training With Active tDCS | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) |
| Computer Training With Sham tDCS | 0/15 (0%) | 0/15 (0%) | 1/15 (6.7%) |
| Computer Training With or Without tDCS | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Event | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS |
|---|---|---|---|
| DizzinessNervous system disorders | 0/16 | 1/15 | 0/15 |
| Reactivation of traumatic memoriesNervous system disorders | 1/16 | 0/15 | 0/15 |
| Age, Continuous(years) | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS | Total |
|---|---|---|---|---|
| Mean | 57.06 ± 4.99 | 58.80 ± 4.13 | 61.07 ± 6.29 | 58.93 ± 5.35 |
| Sex: Female, Male(Participants) | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS | Total |
|---|---|---|---|---|
| Female | 3 | 2 | 4 | 9 |
| Male | 13 | 13 | 11 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS | Total |
|---|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 0 | 6 |
| Not Hispanic or Latino | 13 | 12 | 15 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 11 | 8 | 10 | 29 |
| White | 5 | 7 | 5 | 17 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS | Total |
|---|---|---|---|---|
| United States | 16 | 15 | 15 | 46 |
| Psychomotor Speed(units on a scale) | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS | Total |
|---|---|---|---|---|
| Mean | 48.94 ± 9.28 | 51.67 ± 13.70 | 46.07 ± 15.52 | 48.89 ± 12.93 |
| Functional Status(units on a scale) | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS | Total |
|---|---|---|---|---|
| Mean | 79.75 ± 10.71 | 80.20 ± 19.39 | 76.73 ± 13.72 | 78.91 ± 13.52 |
| Participant Assessment of Own Functioning (PAOF)(units on a scale) | Computer Training With Active tDCS | Computer Training With Sham tDCS | Computer Training With or Without tDCS | Total |
|---|---|---|---|---|
| Mean | 8.18 ± 2.34 | 7.65 ± 4.46 | 8.55 ± 2.49 | 8.13 ± 2.40 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — After the conclusion of the study, de-identified study data will be shared by the study principal investigator with interested individuals.
Supporting information: Study protocol
Time frame: After study conclusion.
Access criteria: Researchers who indicate an interest in using the data for legitimate purposes.
Ran from Jan 2018 to primary completion in Nov 2019, 21 months.
Results were first posted in Sep 2023, 3 years 10 months after primary completion.
Of 80 non-industry interventional studies with no phase under Neurocognitive Disorders, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 46. This study's 21 months is below that.
Counting every sponsor, half of 83 studies reached it within 32 months; a quarter within 17 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nova Southeastern University