Brain Function and Decision-Making
Phase: NA
Conditions: Behavior, Social, Psychology, Social, Social Interaction, Interpersonal Relations
Sponsor: Virginia Commonwealth University

 
 
Title: Brain Functioning and Decision-Making 
 
NCT #: NCT03974282 
 
Document date: 09/04/2019 
 
Document Type: Protocol and Statistical Analysis Plan 
 
 
 

4.1 BRIEF SUMMARY 
 
Aggressive behaviors inflict massive costs on the public health. Psychopathy — the tendency to be callous, 
manipulative, and lack remorse — is one of the most central predictors of aggression and a core feature of 
psychopathology. Psychopathic individuals’ antisocial acts have long been thought to be due to an inability to 
empathize with their victims. However, recent work suggests that psychopathic individuals have intact 
empathic abilities. Instead of employing their empathy to help others, psychopathic individuals appear to use 
empathy to exact greater harm on their victims. Such antisocial empathy, its neural bases, and its effects on 
the aggression of psychopathic individuals remains unexamined. We propose a functional neuroimaging study 
in which we will recruit 36 healthy adult male participants, who are at the low and high extremes of the 
psychopathy distribution (18 per group). While undergoing functional MRI, participants will complete a 
psychological task that evokes antisocially- and prosocially-motivated empathic responding. We predict that 
psychopathic individuals will exhibit greater recruitment of the brain’s cognitive empathy network when 
empathy facilitates antisocial goals (i.e., harming a competitor) and that this neural recruitment will the predict 
greater aggression towards their targets. These findings will serve as an initial foray into this potential new 
frontier for research on psychopathy, empathy, and aggression. If supported, this novel approach would readily 
translate into new motivation-focused interventions and would inform biological and psychological models of 
the monumentally-costly phenomenon of psychopathic aggression. 
 
4.2.a NARRATIVE STUDY DESCRIPTION 
Aggressive behavior is a substantial public health concern in the United States, with approximately 1.2 million 
violent crimes occurring in 20151. Such violent crimes (e.g., aggravated assault, murder, rape) resulted in over 
1.5 million non-fatal injuries and over 17,000 deaths in 20152.  Psychopathy is a well-established risk factor for 
such violence. Understanding the psychological factors (such as antisocial empathy) that explain such 
psychopathic aggression), as well as the neural mechanisms that transmit these effects, is crucial to 
developing effective and targeted psychological and pharmacological interventions that seek to reduce such 
violent outcomes. This project will empirically investigate these phenomena. 
 
4.2.b PRIMARY PURPOSE 
Basic Science 
 
4.2.c INTERVENTIONS 
Behavioral 
 
4.2.d STUDY PHASE 
N/A 
 
4.2.e INTERVENTION MODEL 
Other: Within-participants, repeated-measures experimental manipulation (randomized order) 
 
4.2.f MASKING 
Participant - Yes 
Care Provider - No 
Investigator - Yes 
Outcomes Assessor - No 
 
4.2.g ALLOCATION 
N/A 
 
4.3 OUTCOME MEASURES 
Primary - Change in accuracy of empathic pain judgments 
 
Time frame: collected during intervention. 
Brief description: Accuracy rates for pain ratings of faces during antisocial empathy trials (as compared 
to prosocial empathy trials). 

NIH-Defined Phase III Clinical Trials: N/A 
 
Primary - Change in brain activity assessed by fMRI 
 
Time frame: collected during intervention. 
Brief description: Blood-Oxygen-Level-Dependent signal change (as assessed by functional MRI) in the 
cognitive empathy brain network during antisocial empathy trials (as compared to prosocial empathy 
trials). 
NIH-Defined Phase III Clinical Trials: N/A 
 
4.4 STATISTICAL POWER AND DESIGN 
The MRI Study will employ a 2 (psychopathy: high vs. low) x 2 (empathy-type: antisocial vs. 
prosocial) mixed-effects design. The outcome variables are pain ratings and brain activity during such 
pain ratings. G*Power statistical software (version 3.1) was used to conduct power analyses for this 
interactive effect, revealing that such a moderation model will have at least 80% power to detect a 
modest interactive effect size estimate of f = .08 with 36 participants, 18 per group.  
 
4.5 SUBJECT PARTICIPATION DURATION 
Participation in our study consists of a single, 3-hour laboratory session. 
 
4.5 FDA-REGULATED INTERVENTION? 
No 
 
4.7 DISSEMINATION PLAN 
The PI, Dr. David Chester, has submitted this study as a clinical trial on ClinicalTrials.gov immediately 
after notification of the award (ID: NCT03974282). It is currently under review. As per the NIH Policy 
on the Dissemination of NIH-Funded Clinical Trial Information, the PI will report summary results of 
this study to ClinicalTrials.gov within the timelines specified by this policy. The Clinical Research 
Compliance Program at Virginia Commonwealth University has and will assist Dr. Chester with these 
aforementioned steps and ensure that compliance is maintained with NIH dissemination policies and 
Virginia Commonwealth’s own internal clinical trial dissemination policy.