AggressionNCT04204759
Transcranial Direct Current Stimulation and Antisocial Behavior
A study testing Transcranial direct current stimulation in people with Aggression, run by Nanyang Technological University at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aggression
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteSingapore
- Study dates
- 3 Nov 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 18 (with parental consent) or above 21 (without parental consent)
- Able to understand the nature of the study and give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Aggression
- Being tested
- Transcranial direct current stimulation, Sham transcranial direct current stimulation
- Keywords
- transcranial direct curren stimulation, antisocial behavior
- Medical subject headings
- Aggression, Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Non-invasive stimulation will be conducted using a tDCS device (StarStim, Neuroelectrics, Spain).
Sham transcranial direct current stimulationDevice
The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Points in the Point Subtraction Aggression Paradigm after stimulation
The number of points earned on the lab task will be assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 1 hour after the third consecutive active tDCS or sham session
Secondary outcomes (1)
Number of participants with adverse events
The number of participants reporting the experience of sensations resulting from tDCS will be recorded.
Measured: Within 1 hour after each of the 20-minute active tDCS or sham sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start3 Nov 2019
- Primary completion1 May 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivia Choy, Nanyang Technological University
- Investigators
- Olivia Choy, PhD, Principal investigator, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204759
- Sponsor's protocol ID
- IRB-2019-06-072
- Status last verified
- Oct 2022
- First submitted
- 17 Dec 2019
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial Behavior
- ClinicalTrials.gov ID
- NCT04204759
- Acronym / sponsor ID
- IRB-2019-06-072
- Conditions
- Aggression
- Keywords
- transcranial direct curren stimulation, antisocial behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Study start
- 3 Nov 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal stimulation | Experimental | Device: Transcranial direct current stimulationParticipants 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. |
| Sham stimulation | Sham comparator | Device: Sham transcranial direct current stimulationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Above 18 (with parental consent) or above 21 (without parental consent)
- Able to understand the nature of the study and give informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationNon-invasive stimulation will be conducted using a tDCS device (StarStim, Neuroelectrics, Spain). | Device | Anodal stimulation |
| Sham transcranial direct current stimulationThe same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds. | Device | Sham stimulation |
Primary outcome
Points in the Point Subtraction Aggression Paradigm after stimulation
Time frame: Within 1 hour after the third consecutive active tDCS or sham session
The number of points earned on the lab task will be assessed.
Antisocial behavior inclinations after stimulation
Time frame: Within 1 hour after the third consecutive active tDCS or sham session
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
Time frame: Within 1 hour after the third consecutive active tDCS or sham session
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
Time frame: Within 1 hour after the third consecutive active tDCS or sham session
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
Time frame: Within 1 hour after the third consecutive active tDCS or sham session
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
Time frame: Within 1 hour after the third consecutive active tDCS or sham session
This will be assessed based on the participants' accurate reporting of the number of problems correctly solved in a task.
1 secondary outcome
Number of participants with adverse events
Time frame: Within 1 hour after each of the 20-minute active tDCS or sham sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivia Choy, PhD principal investigator
Nanyang Technological University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Aggression, run by Nanyang Technological University at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Points in the Point Subtraction Aggression Paradigm after stimulation (time frame: Within 1 hour after the third consecutive active tDCS or sham session). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.