- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03974282
Brain Function and Decision-Making
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
• Not meeting the inclusion criteria listed above.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Low psychopathy distribution
Participants who score at the low end of the psychopathy distribution
|
Participants will complete a psychological task that evokes antisocially- and prosocially-motivated empathic responding
|
OTHER: High psychopathy distribution
Participants who score at the high end of the psychopathy distribution
|
Participants will complete a psychological task that evokes antisocially- and prosocially-motivated empathic responding
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Prefrontal Cortex Brain Activity Assessed by fMRI
Time Frame: Baseline to 3 hours
|
Blood-Oxygen-Level-Dependent signal change in the cognitive empathy brain network will be assessed using functional MRI
|
Baseline to 3 hours
|
Change in Accuracy of Empathic Pain Judgments
Time Frame: Baseline to 3 hours
|
Difference in pain judgment scores rated from 1 (low) to 4 (high) between antisocial vs prosocial empathy trials
|
Baseline to 3 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HM20015724
- UL1TR002649 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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