- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04204759
Transcranial Direct Current Stimulation and Antisocial Behavior
October 17, 2022 updated by: Olivia Choy, Nanyang Technological University
The Effect of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial Behavior
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Singapore, Singapore, 639818
- Nanyang Technological University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Anodal stimulation
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.
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Non-invasive stimulation will be conducted using a tDCS device (StarStim, Neuroelectrics, Spain).
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Sham Comparator: Sham stimulation
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.
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The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Points in the Point Subtraction Aggression Paradigm after stimulation
Time Frame: Within 1 hour after the third consecutive active tDCS or sham session
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The number of points earned on the lab task will be assessed.
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Within 1 hour after the third consecutive active tDCS or sham session
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Antisocial behavior inclinations after stimulation
Time Frame: Within 1 hour after the third consecutive active tDCS or sham session
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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.
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Within 1 hour after the third consecutive active tDCS or sham session
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Moral judgment ratings after stimulation
Time Frame: Within 1 hour after the third consecutive active tDCS or sham session
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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.
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Within 1 hour after the third consecutive active tDCS or sham session
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Delay discounting rates after stimulation
Time Frame: Within 1 hour after the third consecutive active tDCS or sham session
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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.
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Within 1 hour after the third consecutive active tDCS or sham session
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Helping behavior after stimulation
Time Frame: Within 1 hour after the third consecutive active tDCS or sham session
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This will be assessed based on the number of easy and hard puzzles participants choose to assign to another participant in the study.
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Within 1 hour after the third consecutive active tDCS or sham session
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Antisocial behavior after stimulation
Time Frame: Within 1 hour after the third consecutive active tDCS or sham session
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This will be assessed based on the participants' accurate reporting of the number of problems correctly solved in a task.
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Within 1 hour after the third consecutive active tDCS or sham session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of participants with adverse events
Time Frame: Within 1 hour after each of the 20-minute active tDCS or sham sessions
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The number of participants reporting the experience of sensations resulting from tDCS will be recorded.
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Within 1 hour after each of the 20-minute active tDCS or sham sessions
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 3, 2019
Primary Completion (Actual)
May 1, 2022
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
December 17, 2019
First Submitted That Met QC Criteria
December 17, 2019
First Posted (Actual)
December 19, 2019
Study Record Updates
Last Update Posted (Actual)
October 18, 2022
Last Update Submitted That Met QC Criteria
October 17, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2019-06-072
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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