- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02674516
The Effect of Repeated Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
January 7, 2022 updated by: University of Pennsylvania
The Effect of Repeated Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial and Aggressive Behavior
This study investigates the relationship between prefrontal cortex activity and antisocial and aggressive behavior, and risk factors for such behavior.
In the double-blind, randomized controlled trial, participants will undergo three sessions of anodal transcranial direct current stimulation of the dorsolateral prefrontal cortex or sham stimulation and complete survey and laboratory measures assessing antisocial behavior and risk factors.
Heart rate and skin conductance will also be measured.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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:
- 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 |
---|---|
Experimental: Anodal stimulation
Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days.
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 DLPFC 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 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Pins Inserted Into a Virtual Voodoo Doll After 48 Hours
Time Frame: On average, 48 hours after the first 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.
|
On average, 48 hours after the first 20-minute tDCS or sham session ends
|
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
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 (Actual)
January 1, 2016
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
June 1, 2021
Study Registration Dates
First Submitted
January 26, 2016
First Submitted That Met QC Criteria
February 3, 2016
First Posted (Estimate)
February 4, 2016
Study Record Updates
Last Update Posted (Actual)
January 18, 2022
Last Update Submitted That Met QC Criteria
January 7, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 823967
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
Clinical Trials on Aggression
-
University of KonstanzCompletedAppetitive AggressionGermany
-
New York State Psychiatric InstituteCompletedIrritable AggressionUnited States
-
Boston UniversityU.S. Department of JusticeCompletedSexual Aggression | Offensive Aggression | Dating Violence Perpetration and VictimizationUnited States
-
Supernus Pharmaceuticals, Inc.CompletedImpulsive AggressionUnited States
-
Weill Medical College of Cornell UniversityGreen Chimneys Residential Treatment Center, Brewster, NYCompletedChildhood AggressionUnited States
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Arizona State UniversityCompletedHeavy Drinking | Sexual AggressionUnited States
-
Children's Hospital Medical Center, CincinnatiCompleted
-
Supernus Pharmaceuticals, Inc.CompletedImpulsive Aggression Comorbid With ADHDUnited Kingdom
-
Arizona State UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Georgia State UniversityNot yet recruitingAlcohol Drinking | Sexual Behavior | Emotions | Sexual AggressionUnited States
-
Arizona State UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Georgia State UniversityCompletedAlcohol Drinking | Sexual Behavior | Emotions | Sexual AggressionUnited States
Clinical Trials on Sham transcranial direct current stimulation
-
Federal University of ParaíbaUnknown
-
D'Or Institute for Research and EducationCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional... and other collaboratorsCompleted
-
University of Campinas, BrazilUnknownEpilepsy IntractableBrazil
-
Federal University of ParaíbaCompleted
-
University of CalgaryAlberta Health servicesRecruitingCervicogenic HeadacheCanada
-
Universidade Federal do Rio Grande do NorteNot yet recruitingLow Back Pain | Transcranial Direct Current Stimulation
-
Nanyang Technological UniversityActive, not recruiting
-
Butler HospitalCompletedChronic Low Back Pain
-
Northwestern UniversityRecruitingDepressionUnited States
-
Johns Hopkins UniversityNational Institute on Aging (NIA)Active, not recruitingTranscranial Direct Current Stimulation