Back to resultsThe Effect of Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
Primary Purpose
Antisocial Behavior, Aggression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sham transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Antisocial Behavior focused on measuring antisocial behavior, aggression, transcranial direct current stimulation, dorsolateral prefrontal cortex, associated risk factors
Eligibility Criteria
Inclusion Criteria:
- Above 18 years of age
- Able to understand the nature of the study and give informed consent
Exclusion Criteria:
- History of or active neurologic, cardiovascular, or psychiatric disease
- Currently consuming anti-convulsant, anti-psychotic, or sedative/hypnotic medications
- Currently consuming anti-depressants
- History of seizures
- Metallic implants on the scalp
- Participation in other transcranial magnetic stimulation (TMS) or tDCS experiments on the same day
- History of adverse reactions to tDCS
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Anodal stimulation
Sham stimulation
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change in Antisocial Behavior Inclinations at 24 Hours
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.
Number of Pins Inserted Into a Virtual Voodoo Doll at 24 Hours
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02427672
First Posted
March 26, 2015
Last Updated
August 14, 2019
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02427672
Brief Title
The Effect of Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
Official Title
The Effect of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial and Aggressive Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study investigates the effect of upregulating prefrontal cortex activity on antisocial and aggressive behavior and risk factors for such behavior. In the double-blind, randomized controlled trial, participants will undergo anodal transcranial direct current stimulation bilaterally to the dorsolateral prefrontal cortex or a sham stimulation. During and after stimulation, they will complete survey and laboratory measures assessing antisocial and aggressive behavior and risk factors for antisocial and aggressive behavior. Heart rate and skin conductance will also be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antisocial Behavior, Aggression
Keywords
antisocial behavior, aggression, transcranial direct current stimulation, dorsolateral prefrontal cortex, associated risk factors
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anodal stimulation
Arm Type
Experimental
Arm 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.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Type
Device
Intervention Name(s)
Sham transcranial direct current stimulation
Primary Outcome Measure Information:
Title
Change in Antisocial Behavior Inclinations at 24 Hours
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
Title
Number of Pins Inserted Into a Virtual Voodoo Doll at 24 Hours
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Above 18 years of age
Able to understand the nature of the study and give informed consent
Exclusion Criteria:
History of or active neurologic, cardiovascular, or psychiatric disease
Currently consuming anti-convulsant, anti-psychotic, or sedative/hypnotic medications
Currently consuming anti-depressants
History of seizures
Metallic implants on the scalp
Participation in other transcranial magnetic stimulation (TMS) or tDCS experiments on the same day
History of adverse reactions to tDCS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Raine, DPhil
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29967006
Citation
Choy O, Raine A, Hamilton RH. Stimulation of the Prefrontal Cortex Reduces Intentions to Commit Aggression: A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group Trial. J Neurosci. 2018 Jul 18;38(29):6505-6512. doi: 10.1523/JNEUROSCI.3317-17.2018. Epub 2018 Jul 2.
Results Reference
result
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The Effect of Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
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