Trial Outcomes & Findings for Modulating Impulsivity in Suicidal Adolescents With Transcranial Direct Current Stimulation (tDCS) (NCT NCT03365102)
NCT ID: NCT03365102
Last Updated: 2022-02-02
Results Overview
The Stop-Signal Task (SST) is a task requiring inhibition of a prepotent motor response. The SST requires participants to respond to a target stimulus as quickly and accurately as possible by pressing a button, but also to withhold their response when they hear an auditory signal. Thus, this task involves a competition between activating and inhibiting processes. The primary outcome variable is change in the stop signal reaction time (SSRT) for the task administered seconds to minutes before and seconds to minutes after stimulation. The theoretical minimum is zero seconds and there is no theoretical maximum. Higher SSRT scores reflect greater impulsivity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
Within an hour post-stimulation condition
Results posted on
2022-02-02
Participant Flow
Participant milestones
| Measure |
Anodal tDCS Over the rIFG,
anodal tDCS over the rIFG,
anodal tDCS over the rIFG,: tDCS at a constant current of 1.5 milliampere (mA) will be applied for one 20-minute session over the right inferior frontal gyrus . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
|
Anodal tDCS Over the lOFC
anodal tDCS over the lOFC
anodal tDCS over the lOFC,: tDCS at a constant current of 1.5 mA will be applied for one 20-minute session over the left orbitofrontal cortex . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
|
Sham tDCS Stimulation
sham tDCS stimulation
sham tDCS stimulation condition: In the sham condition, the current will be ramped up to 1.5 mA for 30 seconds and then ramped back down to 0. As this commonly used sham procedure produces a brief tingling sensation, participants are kept unaware of their experimental condition. Resting-state EEG for 10 minutes will be recorded immediately prior to and after the sham tDCS. After post-sham stimulation resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
20
|
|
Overall Study
COMPLETED
|
18
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 participants were missing data.
Baseline characteristics by cohort
| Measure |
Anodal tDCS Over the rIFG,
n=18 Participants
anodal tDCS over the rIFG,
anodal tDCS over the rIFG,: tDCS at a constant current of 1.5 milliampere (mA) will be applied for one 20-minute session over the right inferior frontal gyrus . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
|
Anodal tDCS Over the lOFC
n=21 Participants
anodal tDCS over the lOFC
anodal tDCS over the lOFC,: tDCS at a constant current of 1.5 mA will be applied for one 20-minute session over the left orbitofrontal cortex . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
|
Sham tDCS Stimulation
n=19 Participants
sham tDCS stimulation
sham tDCS stimulation condition: In the sham condition, the current will be ramped up to 1.5 mA for 30 seconds and then ramped back down to 0. As this commonly used sham procedure produces a brief tingling sensation, participants are kept unaware of their experimental condition. Resting-state EEG for 10 minutes will be recorded immediately prior to and after the sham tDCS. After post-sham stimulation resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=18 Participants
|
21 Participants
n=21 Participants
|
19 Participants
n=19 Participants
|
58 Participants
n=58 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=18 Participants
|
17 Participants
n=21 Participants
|
14 Participants
n=19 Participants
|
45 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=18 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=19 Participants
|
13 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=18 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=19 Participants
|
12 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=18 Participants
|
16 Participants
n=21 Participants
|
17 Participants
n=19 Participants
|
46 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=18 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=19 Participants
|
8 Participants
n=58 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=18 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=19 Participants
|
31 Participants
n=58 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=18 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=19 Participants
|
16 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=58 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
21 participants
n=21 Participants
|
19 participants
n=19 Participants
|
58 participants
n=58 Participants
|
|
PROMIS Depression
|
49 units on a scale
STANDARD_DEVIATION 10 • n=18 Participants • 2 participants were missing data.
|
47 units on a scale
STANDARD_DEVIATION 12 • n=19 Participants • 2 participants were missing data.
|
47 units on a scale
STANDARD_DEVIATION 12 • n=19 Participants • 2 participants were missing data.
|
47.64285714 units on a scale
STANDARD_DEVIATION 11.22728587 • n=56 Participants • 2 participants were missing data.
|
|
Conners-3 Self-Report
Inattention subscale
|
16 units on a scale
STANDARD_DEVIATION 8 • n=17 Participants • 3 participants were missing data
|
16 units on a scale
STANDARD_DEVIATION 9 • n=21 Participants • 3 participants were missing data
|
15 units on a scale
STANDARD_DEVIATION 8 • n=18 Participants • 3 participants were missing data
|
15.67857143 units on a scale
STANDARD_DEVIATION 8.250855918 • n=56 Participants • 3 participants were missing data
|
|
Conners-3 Self-Report
Hyperactivity/impulsivity subscale
|
14 units on a scale
STANDARD_DEVIATION 7 • n=17 Participants • 3 participants were missing data
|
17 units on a scale
STANDARD_DEVIATION 7 • n=20 Participants • 3 participants were missing data
|
12 units on a scale
STANDARD_DEVIATION 7 • n=19 Participants • 3 participants were missing data
|
14.39285714 units on a scale
STANDARD_DEVIATION 7.191354839 • n=56 Participants • 3 participants were missing data
|
|
Stop Signal Task
|
353 milliseconds
STANDARD_DEVIATION 414 • n=16 Participants • 6 participants were missing data
|
276 milliseconds
STANDARD_DEVIATION 328 • n=18 Participants • 6 participants were missing data
|
233 milliseconds
STANDARD_DEVIATION 247 • n=18 Participants • 6 participants were missing data
|
284.8076923 milliseconds
STANDARD_DEVIATION 330.2148165 • n=52 Participants • 6 participants were missing data
|
|
Delay discounting task
|
.45 score on a scale
STANDARD_DEVIATION .3 • n=17 Participants • 3 participants were missing data
|
.31 score on a scale
STANDARD_DEVIATION .22 • n=20 Participants • 3 participants were missing data
|
.5 score on a scale
STANDARD_DEVIATION .31 • n=18 Participants • 3 participants were missing data
|
0.415454545 score on a scale
STANDARD_DEVIATION 0.284301081 • n=55 Participants • 3 participants were missing data
|
PRIMARY outcome
Timeframe: Within an hour post-stimulation conditionThe Stop-Signal Task (SST) is a task requiring inhibition of a prepotent motor response. The SST requires participants to respond to a target stimulus as quickly and accurately as possible by pressing a button, but also to withhold their response when they hear an auditory signal. Thus, this task involves a competition between activating and inhibiting processes. The primary outcome variable is change in the stop signal reaction time (SSRT) for the task administered seconds to minutes before and seconds to minutes after stimulation. The theoretical minimum is zero seconds and there is no theoretical maximum. Higher SSRT scores reflect greater impulsivity.
Outcome measures
| Measure |
Anodal tDCS Over the rIFG,
n=15 Participants
anodal tDCS over the rIFG,
anodal tDCS over the rIFG,: tDCS at a constant current of 1.5 milliampere (mA) will be applied for one 20-minute session over the right inferior frontal gyrus . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
|
Anodal tDCS Over the lOFC
n=15 Participants
anodal tDCS over the lOFC
anodal tDCS over the lOFC,: tDCS at a constant current of 1.5 mA will be applied for one 20-minute session over the left orbitofrontal cortex . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
|
Sham tDCS Stimulation
n=17 Participants
sham tDCS stimulation
sham tDCS stimulation condition: In the sham condition, the current will be ramped up to 1.5 mA for 30 seconds and then ramped back down to 0. As this commonly used sham procedure produces a brief tingling sensation, participants are kept unaware of their experimental condition. Resting-state EEG for 10 minutes will be recorded immediately prior to and after the sham tDCS. After post-sham stimulation resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
|
|---|---|---|---|
|
Stop Signal Task (SST)
|
255 milliseconds
Standard Deviation 463
|
215 milliseconds
Standard Deviation 278
|
297 milliseconds
Standard Deviation 278
|
PRIMARY outcome
Timeframe: Within an hour post-stimulation conditionThis task assessed discounting larger future rewards for smaller immediate ones. The point where a person is equally likely to prefer immediate vs delayed reward (the indifference point) is determined for several and combinations of reward sizes and lengths of time. Area under the curve (AUC) is calculated by summing the results of the following for each delay and indifference point pair: x2-x1\[(y1 + y2)/2\]. x1 and x2 are successive delays and y1 and y2 are indifference points for those delays. AUC range=0-1. Larger AUCs reflect less impulsivity.
Outcome measures
| Measure |
Anodal tDCS Over the rIFG,
n=17 Participants
anodal tDCS over the rIFG,
anodal tDCS over the rIFG,: tDCS at a constant current of 1.5 milliampere (mA) will be applied for one 20-minute session over the right inferior frontal gyrus . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
|
Anodal tDCS Over the lOFC
n=18 Participants
anodal tDCS over the lOFC
anodal tDCS over the lOFC,: tDCS at a constant current of 1.5 mA will be applied for one 20-minute session over the left orbitofrontal cortex . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
|
Sham tDCS Stimulation
n=18 Participants
sham tDCS stimulation
sham tDCS stimulation condition: In the sham condition, the current will be ramped up to 1.5 mA for 30 seconds and then ramped back down to 0. As this commonly used sham procedure produces a brief tingling sensation, participants are kept unaware of their experimental condition. Resting-state EEG for 10 minutes will be recorded immediately prior to and after the sham tDCS. After post-sham stimulation resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
|
|---|---|---|---|
|
Delay Discounting Task
|
.53 score on a scale
Standard Deviation .31
|
.4 score on a scale
Standard Deviation .25
|
.57 score on a scale
Standard Deviation .29
|
Adverse Events
Anodal tDCS Over the rIFG,
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anodal tDCS Over the lOFC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place