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The Effect of Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Description
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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.

Condition or disease Intervention/treatment Phase
Antisocial Behavior Aggression Device: Transcranial direct current stimulation Device: Sham transcranial direct current stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial and Aggressive Behavior
Study Start Date : March 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Anodal stimulation
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.
 Device: Transcranial direct current stimulation
Sham Comparator: 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.
 Device: Sham transcranial direct current stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Change in Antisocial Behavior Inclinations at 24 Hours [ Time Frame: Baseline (an average of 15 minutes before receiving tDCS or sham) and on average, 24 hours following stimulation or sham ]
    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.

  2. Number of Pins Inserted Into a Virtual Voodoo Doll at 24 Hours [ Time Frame: On average, 24 hours after the tDCS or sham session ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427672


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Adrian Raine, DPhil University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Study Protocol and Statistical Analysis Plan  [PDF] November 6, 2017

More Information
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Publications of Results:

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02427672    
Other Study ID Numbers: 821313
First Posted: April 28, 2015    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by University of Pennsylvania:
antisocial behavior
aggression
transcranial direct current stimulation
dorsolateral prefrontal cortex
associated risk factors
Additional relevant MeSH terms:
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Aggression
Antisocial Personality Disorder
Behavioral Symptoms
Personality Disorders
Mental Disorders