Antisocial BehaviorNCT02674516
The Effect of Repeated 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 relationship between prefrontal cortex activity and antisocial and aggressive behavior, and risk factors for such behavior. In the double-blind, randomized controlled trial, participants will undergo three sessions of anodal transcranial direct current stimulation of the dorsolateral… 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2021
- 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
- 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 Repeated Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial and Aggressive Behavior
This study investigates the relationship between prefrontal cortex activity and antisocial and aggressive behavior, and risk factors for such behavior. In the double-blind, randomized controlled trial, participants will undergo three sessions of anodal transcranial direct current stimulation of the dorsolateral prefrontal cortex or sham stimulation and complete survey and laboratory measures assessing antisocial behavior and risk factors. 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.
Sham transcranial direct current stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Anodal stimulation | Experimental | Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. 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 DLPFC 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 2mA (1mA at each DLPFC site) 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.
Number of Pins Inserted Into a Virtual Voodoo Doll After 48 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.
Measured: On average, 48 hours after the first 20-minute tDCS or sham session ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2020
- Study completionJun 2021
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.
- 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, Outcomes assessor
- Enrolment
- 32 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
- NCT02674516
- Sponsor's protocol ID
- 823967
- Status last verified
- Jan 2022
- First submitted
- 26 Jan 2016
- Last updated
- 18 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Repeated Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial and Aggressive Behavior
- ClinicalTrials.gov ID
- NCT02674516
- Acronym / sponsor ID
- 823967
- 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
- 32 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Posted 18 Jan 2022
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 relationship between prefrontal cortex activity and antisocial and aggressive behavior, and risk factors for such behavior. In the double-blind, randomized controlled trial, participants will undergo three sessions of anodal transcranial direct current stimulation of the dorsolateral prefrontal cortex or sham stimulation and complete survey and laboratory measures assessing antisocial behavior and risk factors. 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, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal stimulation | Experimental | Device: Transcranial direct current stimulationParticipants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. 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 DLPFC 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 2mA (1mA at each DLPFC site) 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 (6 listed)
- 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
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
Number of Pins Inserted Into a Virtual Voodoo Doll After 48 Hours
Time frame: On average, 48 hours after the first 20-minute tDCS or sham session ends
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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 6 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 18 Jan 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 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 18 Jan 2022). 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?
Number of Pins Inserted Into a Virtual Voodoo Doll After 48 Hours (time frame: On average, 48 hours after the first 20-minute tDCS or sham session ends). 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 Jan 2022.