NCT04204759

Brief Summary

The main objective of this study is to investigate the causal relationship between prefrontal cortex activity and antisocial behavior, as well as risk factors for antisocial behavior. Specifically, this study tests the hypothesis that upregulating activity in the prefrontal cortex through a non-invasive form of brain stimulation, transcranial direct current stimulation (tDCS) will reduce antisocial and aggressive behavior. The effects of 3 days of anodal stimulation over the prefrontal cortex are assessed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 3, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

2.5 years

First QC Date

December 17, 2019

Last Update Submit

October 17, 2022

Conditions

Keywords

transcranial direct curren stimulationantisocial behavior

Outcome Measures

Primary Outcomes (6)

  • Points in the Point Subtraction Aggression Paradigm after stimulation

    The number of points earned on the lab task will be assessed.

    Within 1 hour after the third consecutive active tDCS or sham session

  • Antisocial behavior inclinations after stimulation

    This will be assessed using 5 hypothetical scenarios in which someone commits a criminal or antisocial act. Participants will respond to the likelihood that they would commit the act in the scenario according to a 10-point Likert scale. Responses are measured on a scale ranging from zero (no chance at all) to 10 (100% chance). A higher value reflects a greater intention to engage in the antisocial act.

    Within 1 hour after the third consecutive active tDCS or sham session

  • Moral judgment ratings after stimulation

    This will be assessed using 5 hypothetical scenarios in which someone commits a criminal or antisocial act. Participants will rate the moral wrongfulness of the act in the scenario on a scale from 0 (not at all) to 10 (very). A higher score reflects a greater perception of moral wrongfulness regarding the antisocial act.

    Within 1 hour after the third consecutive active tDCS or sham session

  • Delay discounting rates after stimulation

    Participants' responses to 5 questions indicating if they would prefer a smaller reward today or a larger reward in the specified number of days will be assessed. The delay discount rates (k) of monetary rewards will be calculated based on the responses to the 5 trials.

    Within 1 hour after the third consecutive active tDCS or sham session

  • Helping behavior after stimulation

    This will be assessed based on the number of easy and hard puzzles participants choose to assign to another participant in the study.

    Within 1 hour after the third consecutive active tDCS or sham session

  • Antisocial behavior after stimulation

    This will be assessed based on the participants' accurate reporting of the number of problems correctly solved in a task.

    Within 1 hour after the third consecutive active tDCS or sham session

Secondary Outcomes (1)

  • Number of participants with adverse events

    Within 1 hour after each of the 20-minute active tDCS or sham sessions

Study Arms (2)

Anodal stimulation

EXPERIMENTAL

Participants in the active stimulation group will undergo anodal transcranial direct current stimulation (tDCS). tDCS will be delivered by a battery-driven, constant-current stimulator connected to two saline-soaked surface sponge electrodes. An anodal electrode (25cm2) will be placed over the ventromedial prefrontal cortex and one cathodal electrode (35cm2) will be placed over the occipital cortex. Scalp electrodes will be positioned according to the 10-20 EEG international system. A current of 2mA will be applied for 20 minutes and the current will be ramped up and down over 30 seconds at the beginning and end of the stimulation period.

Device: Transcranial direct current stimulation

Sham stimulation

SHAM COMPARATOR

The sham tDCS condition will involve the same placement of the electrodes, current intensity, and ramp-up/down time as the active tDCS condition, but stimulation will only last for 30 seconds.

Device: Sham transcranial direct current stimulation

Interventions

Non-invasive stimulation will be conducted using a tDCS device (StarStim, Neuroelectrics, Spain).

Anodal stimulation

The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.

Sham stimulation

Eligibility Criteria

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

You may qualify if:

  • Above 18 (with parental consent) or above 21 (without parental consent)
  • 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 including anxiety disorders (e.g., PTSD, panic attacks, obsessive-compulsive disorder) and mood disorders (e.g., depression)
  • Currently consuming anti-convulsant, anti-psychotic, or sedative/hypnotic medications
  • Currently consuming anti-depressants
  • History of seizures
  • Metallic implants on scalp
  • Participated in any other non-invasive brain stimulation study in the same day
  • Ever had an adverse reaction to tDCS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanyang Technological University

Singapore, 639818, Singapore

Location

MeSH Terms

Conditions

AggressionAntisocial Personality Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial BehaviorPersonality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Olivia Choy, PhD

    Nanyang Technological University

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 19, 2019

Study Start

November 3, 2019

Primary Completion

May 1, 2022

Study Completion

December 31, 2023

Last Updated

October 18, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations