Back to resultsThe Effect of Repeated Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
Primary Purpose
Antisocial Behavior, Aggression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sham transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Antisocial Behavior focused on measuring antisocial behavior, aggression, transcranial direct current stimulation, dorsolateral prefrontal cortex, associated risk factors
Eligibility Criteria
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Anodal stimulation
Sham stimulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Pins Inserted Into a Virtual Voodoo Doll After 48 Hours
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02674516
First Posted
January 26, 2016
Last Updated
January 7, 2022
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02674516
Brief Title
The Effect of Repeated Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
Official Title
The Effect of Repeated Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial and Aggressive Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antisocial Behavior, Aggression
Keywords
antisocial behavior, aggression, transcranial direct current stimulation, dorsolateral prefrontal cortex, associated risk factors
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anodal stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Type
Device
Intervention Name(s)
Sham transcranial direct current stimulation
Primary Outcome Measure Information:
Title
Number of Pins Inserted Into a Virtual Voodoo Doll After 48 Hours
Description
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.
Time Frame
On average, 48 hours after the first 20-minute tDCS or sham session ends
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Raine, DPhil
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Repeated Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
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