Antisocial BehaviorNCT02427672
The Effect of Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
A study testing Transcranial direct current stimulation in people with Antisocial Behavior and Aggression, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study investigates the effect of upregulating prefrontal cortex activity on antisocial and aggressive behavior and risk factors for such behavior. In the double-blind, randomized controlled trial, participants will undergo anodal transcranial direct current stimulation bilaterally to the dorsolateral prefrontal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antisocial Behavior, 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
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years of age
- Able to understand the nature of the study and give informed consent
Who cannot join
- History of or active neurologic, cardiovascular, or psychiatric disease
- Currently consuming anti-convulsant, anti-psychotic, or sedative/hypnotic medications
- Currently consuming anti-depressants
- History of seizures
- Metallic implants on the scalp
- Participation in other transcranial magnetic stimulation (TMS) or tDCS experiments on the same day
- History of adverse reactions to tDCS
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Effect of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial and Aggressive Behavior
This study investigates the effect of upregulating prefrontal cortex activity on antisocial and aggressive behavior and risk factors for such behavior. In the double-blind, randomized controlled trial, participants will undergo anodal transcranial direct current stimulation bilaterally to the dorsolateral prefrontal cortex or a sham stimulation. During and after stimulation, they will complete survey and laboratory measures assessing antisocial and aggressive behavior and risk factors for antisocial and aggressive behavior. Heart rate and skin conductance will also be measured.
- Conditions
- Antisocial Behavior, Aggression
- Being tested
- Transcranial direct current stimulation, Sham transcranial direct current stimulation
- Keywords
- antisocial behavior, aggression, transcranial direct current stimulation, dorsolateral prefrontal cortex, associated risk factors
- Medical subject headings
- Antisocial Personality Disorder, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Sham transcranial direct current stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Anodal stimulation | Experimental | Participants in the active stimulation group will undergo anodal bilateral transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the dorsolateral prefrontal cortex bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 1mA will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period. Receives: Device: Transcranial direct current stimulation |
| Sham stimulation | Sham comparator | The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real 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.
Change in Antisocial Behavior Inclinations at 24 Hours
This will be assessed using hypothetical scenarios in which someone commits a criminal or antisocial act. The two brief scenarios describe a physical assault and a sexual assault. Participants will respond to the likelihood that they would commit the act in the scenario according to a 10-point Likert scale. Responses were measured on a scale ranging from zero (no chance at all) to ten (100 percent chance). Scores for both scenarios were summed to obtain an overall measure of intentions to commit aggression. Possible scores range from 0 to 20. A higher value indicates a greater inclination to engage in the antisocial act.
Measured: Baseline (an average of 15 minutes before receiving tDCS or sham) and on average, 24 hours following stimulation or sham
Number of Pins Inserted Into a Virtual Voodoo Doll at 24 Hours
The number of pins (between 0 and 51) that participants decide to insert into a picture of a voodoo doll on a computer that represents either a romantic partner or close friend will be recorded on average 24 hours after receiving tDCS or sham stimulation.
Measured: On average, 24 hours after the tDCS or sham session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antisocial BehaviorStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Raine, DPhil, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427672
- Sponsor's protocol ID
- 821313
- Status last verified
- Aug 2019
- First submitted
- 26 Mar 2015
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Choy O, Raine A, Hamilton RH. Stimulation of the Prefrontal Cortex Reduces Intentions to Commit Aggression: A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group Trial. J Neurosci. 2018 Jul 18;38(29):6505-6512. doi: 10.1523/JNEUROSCI.3317-17.2018. Epub 2018 Jul 2.
PubMed 29967006
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. 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 and Aggressive Behavior
- ClinicalTrials.gov ID
- NCT02427672
- Acronym / sponsor ID
- 821313
- Conditions
- Antisocial Behavior, Aggression
- Keywords
- antisocial behavior, aggression, transcranial direct current stimulation, dorsolateral prefrontal cortex, associated risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effect of upregulating prefrontal cortex activity on antisocial and aggressive behavior and risk factors for such behavior. In the double-blind, randomized controlled trial, participants will undergo anodal transcranial direct current stimulation bilaterally to the dorsolateral prefrontal cortex or a sham stimulation. During and after stimulation, they will complete survey and laboratory measures assessing antisocial and aggressive behavior and risk factors for antisocial and aggressive behavior. Heart rate and skin conductance will also be measured.
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 bilateral transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the dorsolateral prefrontal cortex bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 1mA will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period. |
| Sham stimulation | Sham comparator | Device: Sham transcranial direct current stimulationThe sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real 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 years of age
- 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
- Currently consuming anti-convulsant, anti-psychotic, or sedative/hypnotic medications
- Currently consuming anti-depressants
- History of seizures
- Metallic implants on the 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 stimulation | Device | Anodal stimulation |
| Sham transcranial direct current stimulation | Device | Sham stimulation |
Primary outcome
Change in Antisocial Behavior Inclinations at 24 Hours
Time frame: Baseline (an average of 15 minutes before receiving tDCS or sham) and on average, 24 hours following stimulation or sham
This will be assessed using hypothetical scenarios in which someone commits a criminal or antisocial act. The two brief scenarios describe a physical assault and a sexual assault. Participants will respond to the likelihood that they would commit the act in the scenario according to a 10-point Likert scale. Responses were measured on a scale ranging from zero (no chance at all) to ten (100 percent chance). Scores for both scenarios were summed to obtain an overall measure of intentions to commit aggression. Possible scores range from 0 to 20. A higher value indicates a greater inclination to engage in the antisocial act.
Number of Pins Inserted Into a Virtual Voodoo Doll at 24 Hours
Time frame: On average, 24 hours after the tDCS or sham session
The number of pins (between 0 and 51) that participants decide to insert into a picture of a voodoo doll on a computer that represents either a romantic partner or close friend will be recorded on average 24 hours after receiving tDCS or sham stimulation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29967006Choy O, Raine A, Hamilton RH. Stimulation of the Prefrontal Cortex Reduces Intentions to Commit Aggression: A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group Trial. J Neurosci. 2018 Jul 18;38(29):6505-6512. doi: 10.1523/JNEUROSCI.3317-17.2018. Epub 2018 Jul 2.
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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.
Adrian Raine, DPhil principal investigator
University of Pennsylvania
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 Antisocial Behavior and Aggression, run by University of Pennsylvania at 1 site in United States.
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: finished, as of the sponsor's last update on 28 Aug 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Antisocial Behavior Inclinations at 24 Hours (time frame: Baseline (an average of 15 minutes before receiving tDCS or sham) and on average, 24 hours following stimulation or sham). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02427672, which also lists 1 linked publication.
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 28 Aug 2019.