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Transcranial Direct Current Stimulation and Antisocial Behavior

Primary Purpose

Aggression

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sham transcranial direct current stimulation
Sponsored by
Nanyang Technological University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
December 17, 2019
Last Updated
October 17, 2022
Sponsor
Nanyang Technological University
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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
Within 1 hour after the third consecutive active tDCS or sham session
Title
Antisocial behavior inclinations after stimulation
Description
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.
Time Frame
Within 1 hour after the third consecutive active tDCS or sham session
Title
Moral judgment ratings after stimulation
Description
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.
Time Frame
Within 1 hour after the third consecutive active tDCS or sham session
Title
Delay discounting rates after stimulation
Description
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.
Time Frame
Within 1 hour after the third consecutive active tDCS or sham session
Title
Helping behavior after stimulation
Description
This will be assessed based on the number of easy and hard puzzles participants choose to assign to another participant in the study.
Time Frame
Within 1 hour after the third consecutive active tDCS or sham session
Title
Antisocial behavior after stimulation
Description
This will be assessed based on the participants' accurate reporting of the number of problems correctly solved in a task.
Time Frame
Within 1 hour after the third consecutive active tDCS or sham session
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Description
The number of participants reporting the experience of sensations resulting from tDCS will be recorded.
Time Frame
Within 1 hour after each of the 20-minute active tDCS or sham sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivia Choy, PhD
Organizational Affiliation
Nanyang Technological University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanyang Technological University
City
Singapore
ZIP/Postal Code
639818
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcranial Direct Current Stimulation and Antisocial Behavior

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