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The Effect of Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior

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ClinicalTrials.gov Identifier: NCT02427672
Recruitment Status : Completed
First Posted : April 28, 2015
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Conditions Antisocial Behavior
Aggression
Interventions Device: Transcranial direct current stimulation
Device: Sham transcranial direct current stimulation
Enrollment 84
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Anodal Stimulation Sham Stimulation
Hide Arm/Group Description

Participants in the active stimulation group will undergo anodal bilateral transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex. 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 dorsolateral prefrontal cortex 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 1mA 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

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

Period Title: Overall Study
Started 40 44
Completed 39 42
Not Completed 1 2
Arm/Group Title Anodal Stimulation Sham Stimulation Total
Hide Arm/Group Description

Participants in the active stimulation group will undergo anodal bilateral transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex. 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 dorsolateral prefrontal cortex 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 1mA 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

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 of all reporting groups
Overall Number of Baseline Participants 39 42 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 42 participants 81 participants
20.26  (4.13) 20.17  (2.36) 20.21  (3.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 42 participants 81 participants
Female 24 21 45
Male 15 21 36
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 42 participants 81 participants
Caucasian
17
  43.6%
19
  45.2%
36
  44.4%
Non-Caucasian
22
  56.4%
23
  54.8%
45
  55.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 39 participants 42 participants 81 participants
39
 100.0%
42
 100.0%
81
 100.0%
1.Primary Outcome
Title Change in Antisocial Behavior Inclinations at 24 Hours
Hide Description This will be assessed using hypothetical scenarios in which someone commits a criminal or antisocial act. The two brief scenarios describe a physical assault and a sexual assault. Participants will respond to the likelihood that they would commit the act in the scenario according to a 10-point Likert scale. Responses were measured on a scale ranging from zero (no chance at all) to ten (100 percent chance). Scores for both scenarios were summed to obtain an overall measure of intentions to commit aggression. Possible scores range from 0 to 20. A higher value indicates a greater inclination to engage in the antisocial act.
Time Frame Baseline (an average of 15 minutes before receiving tDCS or sham) and on average, 24 hours following stimulation or sham
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anodal Stimulation Sham Stimulation
Hide Arm/Group Description:

Participants in the active stimulation group will undergo anodal bilateral transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex. 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 dorsolateral prefrontal cortex 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 1mA 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

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 Number of Participants Analyzed 39 42
Mean (Standard Error)
Unit of Measure: score on a scale
1.41  (.33) 3.05  (.68)
2.Primary Outcome
Title Number of Pins Inserted Into a Virtual Voodoo Doll at 24 Hours
Hide Description 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 on average 24 hours after receiving tDCS or sham stimulation.
Time Frame On average, 24 hours after the tDCS or sham session
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anodal Stimulation Sham Stimulation
Hide Arm/Group Description:

Participants in the active stimulation group will undergo anodal bilateral transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex. 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 dorsolateral prefrontal cortex 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 1mA 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

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 Number of Participants Analyzed 39 42
Mean (Standard Error)
Unit of Measure: pins
5.31  (1.90) 2.62  (1.32)
Time Frame The presence of an adverse event was assessed during the course of one experimental session, from the 20-minute stimulation or sham period to the time that participants completed all study tasks, up to 1 hour.
Adverse Event Reporting Description Subjects responded to a questionnaire regarding 8 possible sensations that may have resulted from tDCS.
 
Arm/Group Title Anodal Stimulation Sham Stimulation
Hide Arm/Group Description

Participants in the active stimulation group will undergo anodal bilateral transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex. 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 dorsolateral prefrontal cortex 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 1mA 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

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

All-Cause Mortality
Anodal Stimulation Sham Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)      0/42 (0.00%)    
Hide Serious Adverse Events
Anodal Stimulation Sham Stimulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      0/42 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Anodal Stimulation Sham Stimulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/39 (100.00%)      39/42 (92.86%)    
General disorders     
Lightheadedness   19/39 (48.72%)  19 14/42 (33.33%)  14
Pain   20/39 (51.28%)  20 18/42 (42.86%)  18
Iron taste   4/39 (10.26%)  4 2/42 (4.76%)  2
Fatigue   15/39 (38.46%)  15 14/42 (33.33%)  14
Skin and subcutaneous tissue disorders     
Itchiness   36/39 (92.31%)  36 33/42 (78.57%)  33
Burning   23/39 (58.97%)  23 17/42 (40.48%)  17
Warmth   22/39 (56.41%)  22 19/42 (45.24%)  19
Pinching   18/39 (46.15%)  18 19/42 (45.24%)  19
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Olivia Choy
Organization: Nanyang Technological University
Phone: (65)65921522
EMail: oliviachoy@ntu.edu.sg
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02427672    
Other Study ID Numbers: 821313
First Submitted: March 26, 2015
First Posted: April 28, 2015
Results First Submitted: February 22, 2019
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019