- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02427672
The Effect of Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
August 14, 2019 updated by: University of Pennsylvania
The Effect of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial and Aggressive Behavior
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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Baseline (an average of 15 minutes before receiving tDCS or sham) and on average, 24 hours following stimulation or sham
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Number of Pins Inserted Into a Virtual Voodoo Doll at 24 Hours
Time Frame: On average, 24 hours after the tDCS or sham session
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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.
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On average, 24 hours after the tDCS or sham session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adrian Raine, DPhil, University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
March 26, 2015
First Submitted That Met QC Criteria
April 22, 2015
First Posted (Estimate)
April 28, 2015
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 14, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 821313
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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