NCT02427672

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

2.8 years

First QC Date

March 26, 2015

Results QC Date

February 22, 2019

Last Update Submit

August 14, 2019

Conditions

Keywords

antisocial behavioraggressiontranscranial direct current stimulationdorsolateral prefrontal cortexassociated risk factors

Outcome Measures

Primary Outcomes (2)

  • Change in Antisocial Behavior Inclinations at 24 Hours

    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.

    Baseline (an average of 15 minutes before receiving tDCS or sham) and on average, 24 hours following stimulation or sham

  • Number of Pins Inserted Into a Virtual Voodoo Doll at 24 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 on average 24 hours after receiving tDCS or sham stimulation.

    On average, 24 hours after the tDCS or sham session

Study Arms (2)

Anodal stimulation

EXPERIMENTAL

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.

Device: Transcranial direct current stimulation

Sham stimulation

SHAM COMPARATOR

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.

Device: Sham transcranial direct current stimulation

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 18 years of age
  • Able to understand the nature of the study and give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Choy O, Raine A, Hamilton RH. Stimulation of the Prefrontal Cortex Reduces Intentions to Commit Aggression: A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group Trial. J Neurosci. 2018 Jul 18;38(29):6505-6512. doi: 10.1523/JNEUROSCI.3317-17.2018. Epub 2018 Jul 2.

MeSH Terms

Conditions

Antisocial Personality DisorderAggression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Results Point of Contact

Title
Dr. Olivia Choy
Organization
Nanyang Technological University

Study Officials

  • Adrian Raine, DPhil

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2015

First Posted

April 28, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

August 28, 2019

Results First Posted

August 28, 2019

Record last verified: 2019-08

Locations