CClinicalTrials.gg
CompletedNCT03974282Updated Feb 6, 2023Results posted

Brain Function and Decision-Making

An interventional study of Psychological task in Behavior, Social, Psychology, Social and Social Interaction, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-06.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

This study is about how brain function and structure is different between two universities. Participant in this project will contribute to a better understanding of how universities affect the brain.

Read the detailed description

Some study details are purposely omitted at this time to preserve scientific integrity. Now that the study is completed, full details are included below.

The true purpose of this study was to investigate the psychometric properties of the two computer tasks that participants completed. Specifically, researchers wanted to know if they would be able to accurately measure motivated empathy. To better understand this, participants were asked to rate images of people expressing pain and were told that these were either students from their university or students from a different university. This was not the case. The faces shown were random images produced for a research study.

Researchers also wanted to know if they could accurately measure moral decision making and how those judgments relate to aggression. To examine this, participants were asked whether various scenarios were immoral and then asked about aggressive tendencies.

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Conditions studied

  • Behavior, Social
  • Psychology, Social
  • Social Interaction
  • Interpersonal Relations
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In context

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Undergraduate students aged 18 - 35 years of age
  • No current or regular use of prescribed or illicit psychoactive drugs
  • Free of major health problems (e.g., diabetes, HIV, Parkinson's disease)
  • Free of a neurological or psychiatric disorders
  • No current drug abuse (e.g., recreational drug use, average alcohol intake in excess of 4 drinks per day).
  • Right hand dominant
  • Free of claustrophobia
  • Free of pregnancy or suspected pregnancy
  • Absent MRI risk factors (e.g., implanted medical device, body mass index > 35, braces)
  • Free of medical conditions that render individuals with overly sensitive hearing
  • No colorblindness

Exclusion criteria

Exclusion Criteria:

  • Not meeting the inclusion criteria listed above.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • Other
    Low psychopathy distribution

    Participants who score at the low end of the psychopathy distribution

    Behavioral: Psychological task

  • Other
    High psychopathy distribution

    Participants who score at the high end of the psychopathy distribution

    Behavioral: Psychological task

Interventions

  • BehavioralPsychological task

    Participants will complete a psychological task that evokes antisocially- and prosocially-motivated empathic responding

06

What researchers measure

Primary outcomes

  1. Change in Prefrontal Cortex Brain Activity Assessed by fMRI

    Blood-Oxygen-Level-Dependent signal change in the cognitive empathy brain network will be assessed using functional MRI

    Time frame: Baseline to 3 hours

  2. Change in Accuracy of Empathic Pain Judgments

    Difference in pain judgment scores rated from 1 (low) to 4 (high) between antisocial vs prosocial empathy trials

    Time frame: Baseline to 3 hours

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Results

Posted Feb 6, 2023

Participant flow

Participant flow — Overall Study
MilestoneLow Psychopathy DistributionHigh Psychopathy Distribution
Started1818
Completed1818
Not completed00

Outcome measures

PrimaryChange in Prefrontal Cortex Brain Activity Assessed by fMRI

Blood-Oxygen-Level-Dependent signal change in the cognitive empathy brain network will be assessed using functional MRI

Time frame:
Baseline to 3 hours
Reported as:
Mean · Percent BOLD Signal Change
Change in Prefrontal Cortex Brain Activity Assessed by fMRI
Percent BOLD Signal ChangeLow Psychopathy DistributionHigh Psychopathy Distribution
Change in Prefrontal Cortex Brain Activity Assessed by fMRI-0.002 ± 0.1630.015 ± 0.105
PrimaryChange in Accuracy of Empathic Pain Judgments

Difference in pain judgment scores rated from 1 (low) to 4 (high) between antisocial vs prosocial empathy trials

Time frame:
Baseline to 3 hours
Reported as:
Mean · difference in pain scores
Change in Accuracy of Empathic Pain Judgments
difference in pain scoresLow Psychopathy DistributionHigh Psychopathy Distribution
Change in Accuracy of Empathic Pain Judgments.49 ± .14.39 ± .14

Adverse events

Collected over 3 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Participants0/36 (0%)0/36 (0%)0/36 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Low Psychopathy DistributionHigh Psychopathy DistributionTotal
Mean20.24 ± 2.7520.59 ± 2.1220.41 ± 2.43
Sex: Female, Male
Sex: Female, Male(Participants)Low Psychopathy DistributionHigh Psychopathy DistributionTotal
Female000
Male181836
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Low Psychopathy DistributionHigh Psychopathy DistributionTotal
Race — Asian358
Race — Black or African-American516
Race — Pacific Islander101
Race — White - Hispanic314
Race — Missing Data112
Race — Multiracial101
Race — Other Race202
Race — White - Non-Hispanic21012
Region of Enrollment
Region of Enrollment(participants)Low Psychopathy DistributionHigh Psychopathy DistributionTotal
United States181836
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Study locations

1 site
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
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References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 4, 2019
  • Informed consent form · Jun 5, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03974282
Lead sponsor
Virginia Commonwealth University
Collaborators
National Center for Advancing Translational Sciences (NCATS)
Responsible party
Sponsor
First posted
Jun 4, 2019
Start date
Jun 20, 2019
Primary completion
Mar 16, 2020
Completion
Mar 16, 2020
Results posted
Feb 6, 2023
Last update
Feb 6, 2023

Study contacts

David Chester, PhD
principal investigator · Virginia Commonwealth University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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