Trial Outcomes & Findings for Computer Training and Transcranial Direct Current Stimulation for Cognition in HIV (NCT NCT03440840)
NCT ID: NCT03440840
Last Updated: 2023-09-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
3 weeks
Results posted on
2023-09-18
Participant Flow
Participant milestones
| Measure |
Computer Training With Active tDCS
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with active transcranial direct current stimulation (tDCS).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With Sham tDCS
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with sham transcranial direct current stimulation (tDCS).
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With or Without tDCS
Participants in this arm will watch educational videos as a comparator to computer training with the car racing game (watching educational videos).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Watching Educational Videos: Watching educational videos and answering questions about them
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Computer Training and Transcranial Direct Current Stimulation for Cognition in HIV
Baseline characteristics by cohort
| Measure |
Computer Training With Active tDCS
n=16 Participants
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with active transcranial direct current stimulation (tDCS).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With Sham tDCS
n=15 Participants
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with sham transcranial direct current stimulation (tDCS).
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With or Without tDCS
n=15 Participants
Participants in this arm will watch educational videos as a comparator to computer training with the car racing game (watching educational videos).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Watching Educational Videos: Watching educational videos and answering questions about them
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.06 years
STANDARD_DEVIATION 4.99 • n=5 Participants
|
58.80 years
STANDARD_DEVIATION 4.13 • n=7 Participants
|
61.07 years
STANDARD_DEVIATION 6.29 • n=5 Participants
|
58.93 years
STANDARD_DEVIATION 5.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Psychomotor Speed
|
48.94 units on a scale
STANDARD_DEVIATION 9.28 • n=5 Participants
|
51.67 units on a scale
STANDARD_DEVIATION 13.70 • n=7 Participants
|
46.07 units on a scale
STANDARD_DEVIATION 15.52 • n=5 Participants
|
48.89 units on a scale
STANDARD_DEVIATION 12.93 • n=4 Participants
|
|
Functional Status
|
79.75 units on a scale
STANDARD_DEVIATION 10.71 • n=5 Participants
|
80.20 units on a scale
STANDARD_DEVIATION 19.39 • n=7 Participants
|
76.73 units on a scale
STANDARD_DEVIATION 13.72 • n=5 Participants
|
78.91 units on a scale
STANDARD_DEVIATION 13.52 • n=4 Participants
|
|
Participant Assessment of Own Functioning (PAOF)
|
8.18 units on a scale
STANDARD_DEVIATION 2.34 • n=5 Participants
|
7.65 units on a scale
STANDARD_DEVIATION 4.46 • n=7 Participants
|
8.55 units on a scale
STANDARD_DEVIATION 2.49 • n=5 Participants
|
8.13 units on a scale
STANDARD_DEVIATION 2.40 • n=4 Participants
|
|
Center for Epidemiological Studies Depression Scale (CES-D)
|
14.00 units on a scale
STANDARD_DEVIATION 7.55 • n=5 Participants
|
15.27 units on a scale
STANDARD_DEVIATION 9.24 • n=7 Participants
|
15.13 units on a scale
STANDARD_DEVIATION 7.19 • n=5 Participants
|
14.78 units on a scale
STANDARD_DEVIATION 7.87 • n=4 Participants
|
PRIMARY outcome
Timeframe: 3 weeksAbility 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.
Outcome measures
| Measure |
Computer Training With Active tDCS
n=15 Participants
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with active transcranial direct current stimulation (tDCS).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With Sham tDCS
n=14 Participants
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with sham transcranial direct current stimulation (tDCS).
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With or Without tDCS
n=15 Participants
Participants in this arm will watch educational videos as a comparator to computer training with the car racing game (watching educational videos).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Watching Educational Videos: Watching educational videos and answering questions about them
|
|---|---|---|---|
|
Psychomotor Speed
|
54.2 score on a scale
Interval 43.2 to 65.2
|
60.4 score on a scale
Interval 49.4 to 71.4
|
53.4 score on a scale
Interval 42.6 to 64.2
|
SECONDARY outcome
Timeframe: 3 weeksParticipant 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.
Outcome measures
| Measure |
Computer Training With Active tDCS
n=15 Participants
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with active transcranial direct current stimulation (tDCS).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With Sham tDCS
n=14 Participants
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with sham transcranial direct current stimulation (tDCS).
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With or Without tDCS
n=15 Participants
Participants in this arm will watch educational videos as a comparator to computer training with the car racing game (watching educational videos).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Watching Educational Videos: Watching educational videos and answering questions about them
|
|---|---|---|---|
|
Functional Status
|
84.6 score on a scale
Interval 74.8 to 94.5
|
82.8 score on a scale
Interval 72.9 to 92.6
|
84.4 score on a scale
Interval 74.8 to 94.0
|
SECONDARY outcome
Timeframe: 3 weeksParticipant 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.
Outcome measures
| Measure |
Computer Training With Active tDCS
n=15 Participants
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with active transcranial direct current stimulation (tDCS).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With Sham tDCS
n=14 Participants
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with sham transcranial direct current stimulation (tDCS).
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With or Without tDCS
n=15 Participants
Participants in this arm will watch educational videos as a comparator to computer training with the car racing game (watching educational videos).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Watching Educational Videos: Watching educational videos and answering questions about them
|
|---|---|---|---|
|
Participant Assessment of Own Functioning (PAOF)
|
7.98 score on a scale
Interval 6.27 to 9.69
|
7.73 score on a scale
Interval 6.01 to 9.44
|
7.86 score on a scale
Interval 6.19 to 9.52
|
SECONDARY outcome
Timeframe: 3 weeksParticipant 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.
Outcome measures
| Measure |
Computer Training With Active tDCS
n=15 Participants
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with active transcranial direct current stimulation (tDCS).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With Sham tDCS
n=14 Participants
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with sham transcranial direct current stimulation (tDCS).
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With or Without tDCS
n=15 Participants
Participants in this arm will watch educational videos as a comparator to computer training with the car racing game (watching educational videos).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Watching Educational Videos: Watching educational videos and answering questions about them
|
|---|---|---|---|
|
Center for Epidemiological Studies Depression Scale (CES-D)
|
16.5 score on a scale
Interval 9.53 to 23.5
|
16.6 score on a scale
Interval 9.59 to 23.7
|
16.3 score on a scale
Interval 9.54 to 23.1
|
Adverse Events
Computer Training With Active tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Computer Training With Sham tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Computer Training With or Without tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Computer Training With Active tDCS
n=16 participants at risk
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with active transcranial direct current stimulation (tDCS).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With Sham tDCS
n=15 participants at risk
Participants randomized to this arm will receive computer-based cognitive training using a car racing game with sham transcranial direct current stimulation (tDCS).
Computer-based Cognitive Training: Use of computer-delivered games or exercises with the goal of improving cognitive performance.
|
Computer Training With or Without tDCS
n=15 participants at risk
Participants in this arm will watch educational videos as a comparator to computer training with the car racing game (watching educational videos).
Transcranial Direct Current Stimulation (tDCS): Application of a small electrical current (1-2 mA) across the head.
Watching Educational Videos: Watching educational videos and answering questions about them
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • 7 weeks
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
6.7%
1/15 • Number of events 1 • 7 weeks
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/15 • 7 weeks
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Nervous system disorders
Reactivation of traumatic memories
|
6.2%
1/16 • Number of events 1 • 7 weeks
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/15 • 7 weeks
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/15 • 7 weeks
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place