NCT02674516

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 18, 2022

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

4.4 years

First QC Date

January 26, 2016

Results QC Date

August 18, 2021

Last Update Submit

January 7, 2022

Conditions

Keywords

antisocial behavioraggressiontranscranial direct current stimulationdorsolateral prefrontal cortexassociated risk factors

Outcome Measures

Primary Outcomes (1)

  • 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.

    On average, 48 hours after the first 20-minute tDCS or sham session ends

Study Arms (2)

Anodal stimulation

EXPERIMENTAL

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.

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:

  • 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

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, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 4, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2021

Last Updated

January 18, 2022

Results First Posted

January 18, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations