Trial Outcomes & Findings for The Effect of Repeated Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior (NCT NCT02674516)
NCT ID: NCT02674516
Last Updated: 2022-01-18
Results Overview
The number of pins (between 0 and 51) that participants decide to insert into a picture of a voodoo doll on a computer that represents either a romantic partner or close friend will be recorded.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
On average, 48 hours after the first 20-minute tDCS or sham session ends
Results posted on
2022-01-18
Participant Flow
Participant milestones
| Measure |
Anodal Stimulation
Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.
Transcranial direct current stimulation
|
Sham Stimulation
The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.
Sham transcranial direct current stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Anodal Stimulation
Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.
Transcranial direct current stimulation
|
Sham Stimulation
The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.
Sham transcranial direct current stimulation
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Protocol Violation
|
0
|
4
|
|
Overall Study
Knowledge of study hypothesis
|
1
|
0
|
Baseline Characteristics
The Effect of Repeated Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
Baseline characteristics by cohort
| Measure |
Anodal Stimulation
n=13 Participants
Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.
Transcranial direct current stimulation
|
Sham Stimulation
n=11 Participants
The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.
Sham transcranial direct current stimulation
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.15 years
STANDARD_DEVIATION 10.77 • n=5 Participants
|
33.27 years
STANDARD_DEVIATION 14.10 • n=7 Participants
|
32.13 years
STANDARD_DEVIATION 12.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: On average, 48 hours after the first 20-minute tDCS or sham session endsThe number of pins (between 0 and 51) that participants decide to insert into a picture of a voodoo doll on a computer that represents either a romantic partner or close friend will be recorded.
Outcome measures
| Measure |
Anodal Stimulation
n=13 Participants
Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.
Transcranial direct current stimulation
|
Sham Stimulation
n=11 Participants
The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.
Sham transcranial direct current stimulation
|
|---|---|---|
|
Number of Pins Inserted Into a Virtual Voodoo Doll After 48 Hours
|
3.77 pins
Standard Deviation 8.88
|
.64 pins
Standard Deviation 1.50
|
Adverse Events
Anodal Stimulation
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Sham Stimulation
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anodal Stimulation
n=13 participants at risk
Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.
Transcranial direct current stimulation
|
Sham Stimulation
n=11 participants at risk
The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.
Sham transcranial direct current stimulation
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Itchiness
|
92.3%
12/13 • Number of events 12 • 48 hours after the end of the first stimulation session
|
36.4%
4/11 • Number of events 4 • 48 hours after the end of the first stimulation session
|
|
General disorders
Lightheadedness
|
23.1%
3/13 • Number of events 3 • 48 hours after the end of the first stimulation session
|
9.1%
1/11 • Number of events 1 • 48 hours after the end of the first stimulation session
|
|
Skin and subcutaneous tissue disorders
Pain
|
46.2%
6/13 • Number of events 6 • 48 hours after the end of the first stimulation session
|
27.3%
3/11 • Number of events 3 • 48 hours after the end of the first stimulation session
|
|
Skin and subcutaneous tissue disorders
Burning
|
69.2%
9/13 • Number of events 9 • 48 hours after the end of the first stimulation session
|
36.4%
4/11 • Number of events 4 • 48 hours after the end of the first stimulation session
|
|
Skin and subcutaneous tissue disorders
Mild warmth
|
38.5%
5/13 • Number of events 5 • 48 hours after the end of the first stimulation session
|
9.1%
1/11 • Number of events 1 • 48 hours after the end of the first stimulation session
|
|
Skin and subcutaneous tissue disorders
Pinching
|
46.2%
6/13 • Number of events 6 • 48 hours after the end of the first stimulation session
|
27.3%
3/11 • Number of events 3 • 48 hours after the end of the first stimulation session
|
|
General disorders
Iron taste
|
15.4%
2/13 • Number of events 2 • 48 hours after the end of the first stimulation session
|
9.1%
1/11 • Number of events 1 • 48 hours after the end of the first stimulation session
|
|
General disorders
Fatigue
|
23.1%
3/13 • Number of events 3 • 48 hours after the end of the first stimulation session
|
9.1%
1/11 • Number of events 1 • 48 hours after the end of the first stimulation session
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place