Transcranial Direct Current Stimulation and Antisocial Behavior

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Transcranial direct current stimulation

Sham transcranial direct current stimulation

About this trial

This is an interventional basic science trial for Aggression focused on measuring transcranial direct curren stimulation, antisocial behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Above 18 (with parental consent) or above 21 (without parental consent)
Able to understand the nature of the study and give informed consent

Exclusion Criteria:

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

Sites / Locations

Nanyang Technological University

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 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.

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.

Outcomes

Primary Outcome Measures

Points in the Point Subtraction Aggression Paradigm after stimulation

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

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.

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.

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.

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.

Antisocial behavior after stimulation

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

Secondary Outcome Measures

Number of participants with adverse events

The number of participants reporting the experience of sensations resulting from tDCS will be recorded.

Full Information

NCT ID

NCT04204759

First Posted

December 17, 2019

Last Updated

October 17, 2022

Sponsor

Nanyang Technological University

1. Study Identification

Unique Protocol Identification Number

NCT04204759

Brief Title

Transcranial Direct Current Stimulation and Antisocial Behavior

Official Title

The Effect of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial Behavior

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 3, 2019 (Actual)

Primary Completion Date

May 1, 2022 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanyang Technological University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aggression

Keywords

transcranial direct curren stimulation, antisocial behavior

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Anodal stimulation

Arm Type

Experimental

Arm Description

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.

Arm Title

Sham stimulation

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Transcranial direct current stimulation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Sham transcranial direct current stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Points in the Point Subtraction Aggression Paradigm after stimulation

Description

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

Time Frame