Trial Outcomes & Findings for At-home Transcranial Alternating Current Stimulation During Multitasking (NCT NCT04231825)
NCT ID: NCT04231825
Last Updated: 2022-03-21
Results Overview
Assessment of multitasking ability using change from baseline scores in d' cost (metric of discriminability). Discrimination performance (d') was measured for each participant by comparing hit (correct responses to target signs) rates and false alarm (responses to non-targets) rates and calculated as d' = Z (hits) - Z (false alarms). d' cost was then calculated as the ratio of d' during single task target discrimination task to multitask target discrimination, expressed as percentage cost.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Pre-tACS and post-tACS (1 week later)
Results posted on
2022-03-21
Participant Flow
Participant milestones
| Measure |
Verum Stimulation
This group will receive 6-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
Frequency Control
This group will receive 1-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Verum Stimulation
This group will receive 6-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
Frequency Control
This group will receive 1-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Only data from participants who completed the full protocol were analyzed
Baseline characteristics by cohort
| Measure |
Verum Stimulation
n=23 Participants
This group will receive 6-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
Frequency Control
n=24 Participants
This group will receive 1-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
1 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
2 Participants
n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
19 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
38 Participants
n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
0 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
0 Participants
n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Age, Continuous
|
25.8 years
STANDARD_DEVIATION 4.6 • n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
24.6 years
STANDARD_DEVIATION 4.2 • n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
25.2 years
STANDARD_DEVIATION 4.4 • n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Sex: Female, Male
Female
|
12 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
13 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
25 Participants
n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
7 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
15 Participants
n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
0 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
0 Participants
n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
4 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
7 Participants
n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
0 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
0 Participants
n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
2 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
3 Participants
n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Race (NIH/OMB)
White
|
15 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
12 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
27 Participants
n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
2 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
3 Participants
n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
0 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
0 Participants
n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Region of Enrollment
United States
|
20 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
20 Participants
n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
40 Participants
n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Single Task Performance
|
1.73 d'
STANDARD_DEVIATION 0.63 • n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
2.01 d'
STANDARD_DEVIATION 0.63 • n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
1.87 d'
STANDARD_DEVIATION 0.63 • n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Multitask performance
|
1.03 d'
STANDARD_DEVIATION 0.63 • n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
1.20 d'
STANDARD_DEVIATION 0.58 • n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
1.12 d'
STANDARD_DEVIATION 0.60 • n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Multitasking Cost Performance
|
45.8 Percent change
STANDARD_DEVIATION 0.40 • n=20 Participants • Only data from participants who completed the full protocol were analyzed.
|
40.5 Percent change
STANDARD_DEVIATION 0.22 • n=20 Participants • Only data from participants who completed the full protocol were analyzed.
|
43.2 Percent change
STANDARD_DEVIATION 0.31 • n=40 Participants • Only data from participants who completed the full protocol were analyzed.
|
|
Continuous Performance Task RT
|
322 milliseconds
STANDARD_DEVIATION 43 • n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
322 milliseconds
STANDARD_DEVIATION 34 • n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
322 milliseconds
STANDARD_DEVIATION 39 • n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
|
Continuous Performance Task RTV
|
76 milliseconds
STANDARD_DEVIATION 7 • n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
65 milliseconds
STANDARD_DEVIATION 5 • n=20 Participants • Only data from participants who completed the full protocol were analyzed
|
71 milliseconds
STANDARD_DEVIATION 6 • n=40 Participants • Only data from participants who completed the full protocol were analyzed
|
PRIMARY outcome
Timeframe: Pre-tACS and post-tACS (1 week later)Population: Only data from participants who completed the full protocol were analyzed
Assessment of multitasking ability using change from baseline scores in d' cost (metric of discriminability). Discrimination performance (d') was measured for each participant by comparing hit (correct responses to target signs) rates and false alarm (responses to non-targets) rates and calculated as d' = Z (hits) - Z (false alarms). d' cost was then calculated as the ratio of d' during single task target discrimination task to multitask target discrimination, expressed as percentage cost.
Outcome measures
| Measure |
Verum Stimulation
n=20 Participants
This group will receive 6-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
Frequency Control
n=20 Participants
This group will receive 1-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
|---|---|---|
|
Multitasking Performance Cost (Neuroracer Performance Change From Baseline)
|
45.3 percentage change of d'
Standard Deviation 0.31
|
37.9 percentage change of d'
Standard Deviation 0.27
|
PRIMARY outcome
Timeframe: Pre-tACS and post-tACS (1 week later)Population: Only data from participants who completed the full protocol were analyzed
Discrimination performance (d') was measured during single task performance for each participant by comparing hit (correct responses to target signs) rates and false alarm (responses to non-targets) rates and calculated as d' = Z (hits) - Z (false alarms). Performance data was collected during the single task condition.
Outcome measures
| Measure |
Verum Stimulation
n=20 Participants
This group will receive 6-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
Frequency Control
n=20 Participants
This group will receive 1-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
|---|---|---|
|
Single Task Performance Change
|
1.99 d'
Standard Deviation 0.94
|
2.70 d'
Standard Deviation 1.07
|
PRIMARY outcome
Timeframe: Pre-tACS and post-tACS (1 week later)Population: Only data from participants who completed the full protocol were analyzed
Discrimination performance (d') was measured while multitasking for each participant by comparing hit (correct responses to target signs) rates and false alarm (responses to non-targets) rates and calculated as d' = Z (hits) - Z (false alarms). Performance data was collected during the multitask condition.
Outcome measures
| Measure |
Verum Stimulation
n=20 Participants
This group will receive 6-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
Frequency Control
n=20 Participants
This group will receive 1-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
|---|---|---|
|
Multitask Performance Change
|
1.17 d'
Standard Deviation 0.76
|
1.79 d'
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Pre-tACS and post-tACS (1 week later)Population: Only data from participants who completed the full protocol were analyzed
Assessment of sustained attention ability using response time (in ms) during the continuous performance test
Outcome measures
| Measure |
Verum Stimulation
n=20 Participants
This group will receive 6-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
Frequency Control
n=20 Participants
This group will receive 1-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
|---|---|---|
|
Continuous Performance Test RT Change (Test of Visual Attention / Sustained Attention)
|
300 milliseconds
Standard Deviation 42
|
303 milliseconds
Standard Deviation 31
|
SECONDARY outcome
Timeframe: Pre-tACS and post-tACS (1 week later)Population: Only data from participants who completed the full protocol were analyzed
Assessment of sustained attention ability using response time variability (standard deviation of response times in ms) during the continuous performance test
Outcome measures
| Measure |
Verum Stimulation
n=20 Participants
This group will receive 6-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
Frequency Control
n=20 Participants
This group will receive 1-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
|---|---|---|
|
Continuous Performance Test RTV Change (Test of Visual Attention / Sustained Attention)
|
58 milliseconds
Standard Deviation 26
|
56 milliseconds
Standard Deviation 21
|
Adverse Events
Verum Stimulation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Frequency Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Verum Stimulation
n=23 participants at risk
This group will receive 6-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
Frequency Control
n=24 participants at risk
This group will receive 1-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
|
|---|---|---|
|
Product Issues
Other (Not Including Serious) Adverse Event
|
4.3%
1/23 • Number of events 1 • 10 months
|
8.3%
2/24 • Number of events 2 • 10 months
|
Additional Information
Dr. Theodore Zanto
University of California San Francisco
Phone: 415-502-7322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place