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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

Tracking Information
First Submitted Date  ICMJE March 26, 2015
First Posted Date  ICMJE April 28, 2015
Results First Submitted Date  ICMJE February 22, 2019
Results First Posted Date  ICMJE August 28, 2019
Last Update Posted Date August 28, 2019
Study Start Date  ICMJE March 2015
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
  • Change in antisocial behavior inclinations at 40 minutes [ Time Frame: Baseline (an average of 15 minutes before receiving tDCS or sham) and within 40 minutes following stimulation or sham ]
    This will be assessed using 10 hypothetical scenarios in which someone commits a criminal or antisocial act. Participants will respond to the likelihood that they would commit the act in the scenario according to a 10-point Likert scale.
  • 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 10 hypothetical scenarios in which someone commits a criminal or antisocial act. Participants will respond to the likelihood that they would commit the act in the scenario according to a 10-point Likert scale.
  • Number of pins inserted into a virtual voodoo doll at 40 minutes [ Time Frame: Within 40 minutes after the 20-minute tDCS or sham session ends ]
    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 within 40 minutes after receiving tDCS or sham stimulation.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
  • Mean reaction time to visual stimuli [ Time Frame: Between 0 and 10 minutes of receiving tDCS or sham stimulation ]
    Attention performance will be assessed by subjects' response times to target stimuli shown at random intervals for 10 minutes.
  • Number of attentional lapses in responding to visual stimuli [ Time Frame: Between 0 and 10 minutes of receiving tDCS or sham stimulation ]
    Attention performance will also be assessed by the number of attentional lapses, considered as the number of trials in the 10-minute task in which subjects respond 500 ms or later after the visual stimulus has been shown.
  • Number of cards picked from the two "risky decks" in the Iowa Gambling Task [ Time Frame: Between 10 and 20 minutes after the start of receving tDCS or sham stimulation ]
    The number of cards picked from the two "risky decks", where money is lost in the long-run, rather than the two "safe decks" in the Iowa Gambling Task will be recorded. Specifically, the number of cards picked from the two ''risky decks'' in the second half of the task will be summed.
  • Delayed reward discounting rate [ Time Frame: Within 40 minutes after the 20-minute tDCS or sham session ends ]
    Subjects' estimated delayed reward discounting rate is calculated as the geometric mean of the discounting rate at indifference between the 2 questions out of 27 that reflect when the subject changes between choosing a delayed reward rather than an immediate reward.
  • Number of balloon pumps in the Balloon Analogue Risk Task [ Time Frame: Within 40 minutes after the 20-minute tDCS or sham session ends ]
    The number of balloon pumps, measured by the number of times subjects press a button to pump up a computerized balloon over 30 trials, will be measured.
  • Choice regarding the length of a prison sentence in a hypothetical juror scenario [ Time Frame: Within 40 minutes after the 20-minute tDCS or sham session ends ]
    The participant's choice out of 7 options in a multiple-choice format regarding the length of a prison sentence, if any, that an offender should serve following a 2-year, nearly 100% effective rehabilitation treatment in a fictional vignette, will be recorded to assess retributive punishment.
  • Sum of self-reported ratings on free will beliefs in Paulhus and Carey's (2011) Free Will and Determinism Plus Scale [ Time Frame: Within 40 minutes after the 20-minute tDCS or sham session ends ]
    The self-reported ratings on seven items, based on a five-point scale in Paulhus and Carey's (2011) Free Will and Determinism Plus questionnaire, will be summed to obtain a composite score reflecting free will beliefs.
  • The occurrence of a moral or immoral event in the 3 hours prior to the testing session [ Time Frame: Within 40 minutes after the 20-minute tDCS or sham session ends ]
    Participants indicate whether they have experienced a moral or immoral event in the 3 hours prior to the testing session as a qualitative assessment of their perception of moral experiences in daily life.
  • Decisions to keep or transfer endowments to a fictional player [ Time Frame: Within 40 minutes after the 20-minute tDCS or sham session ends ]
    Participants' decisions to keep or transfer 10 monetary units to another player in a one-shot prisoner's dilemma game will be assessed as a measure of level of cooperation.
  • The amount of money participants would offer and accept from a fictional player in an ultimatum game [ Time Frame: Within 40 minutes after the 20-minute tDCS or sham session ends ]
    As another measure of cooperative behavior, participants' decisions about how much money they would offer and accept from another player will be recorded in a one-shot ultimatum game.
  • Heart rate levels in response to emotionally provocative stimuli [ Time Frame: Between 10 and 20 minutes after the start of receving tDCS or sham stimulation ]
    Heart rate levels in beats per minute will be recorded.
  • Skin conductance levels in response to emotionally provocative stimuli [ Time Frame: Between 10 and 20 minutes after the start of receving tDCS or sham stimulation ]
    Skin conductance levels, in seimens, will be recorded.
  • Change in ratings of positive and negative affect according to the Positive and Negative Affect Schedule (PANAS) at 40 minutes [ Time Frame: Baseline (an average of 15 minutes before receiving tDCS or sham) and within 40 minutes following stimulation or sham ]
    Participants' responses to 41 adjectives on a 5-point Likert scale will be assessed. Levels of positive and negative affect will be calculated based on the sum of their ratings.
  • Change in sleep quality 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 ]
    A score of sleep quality will be obtained based on responses to 4 questions, using the standardized, quantitative Pittsburgh Sleep Quality Index.
  • Resting heart rate [ Time Frame: Between 10 and 20 minutes after the start of receving tDCS or sham stimulation ]
    Heart rate during a rest task will be recorded in beats per minute.
  • Resting skin conductance level [ Time Frame: Between 10 and 20 minutes after the start of rec ]
    Skin conductance levels during a rest task will be recorded in seimens.
  • Number of participants with adverse events [ Time Frame: Within 40 minutes after the 20-minute tDCS or sham session ends ]
    The number of participants reporting the experience of 8 possible sensations resulting from tDCS will be recorded.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
Official Title  ICMJE The Effect of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial and Aggressive Behavior
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Antisocial Behavior
  • Aggression
Intervention  ICMJE
  • Device: Transcranial direct current stimulation
  • Device: Sham transcranial direct current stimulation
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Device: Sham transcranial direct current stimulation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2019)
84
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2015)
80
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02427672
Other Study ID Numbers  ICMJE 821313
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adrian Raine, DPhil University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP