AggressionNCT03036683
Transcranial Direct Current Stimulation in Offenders
A study testing Transcranial direct current stimulation in people with Aggression and Risk-Taking, run by Olivia Choy at 1 site in Germany.
Trial summary
This study investigates the effect of upregulating prefrontal cortex activity on risk-taking, and antisocial and aggressive behavior in violent offenders. In the double-blind, randomized controlled trial, using a within-subject crossover design, each participant will undergo anodal transcranial direct current… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aggression, Risk-Taking, Antisocial Behavior
- 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
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2017to 1 Jun 2022
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 50 years of age
- Able to understand the nature of the study and give informed consent
- Individuals in the violent offender group must have a record of repeated violent criminal offending (at least 2 felonies).
- Individuals in the violent offender group must have been convicted solely due to crimes involving violence motivated by impulsive aggression.
Who cannot join
- Presence of any contraindications for functional magnetic resonance imaging (fMRI)
- History of significant medical illness
- History of any neurological condition
- Diagnosis of schizophrenia
- History of epilepsy
- Head injury
- Mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Transcranial Direct Current Stimulation on Risk-taking and Aggression in Offenders
This study investigates the effect of upregulating prefrontal cortex activity on risk-taking, and antisocial and aggressive behavior in violent offenders. In the double-blind, randomized controlled trial, using a within-subject crossover design, each participant will undergo anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex and sham stimulation. After each stimulation session, neural activity and behavioral responses to tasks assessing risk-taking and aggressive behavior will be recorded. The effect of tDCS on violent offenders will also be assessed in comparison to age and gender-matched healthy controls.
- Conditions
- Aggression, Risk-Taking, Antisocial Behavior
- Being tested
- Transcranial direct current stimulation, Sham transcranial direct current stimulation
- Medical subject headings
- Aggression, Risk-Taking, 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
Transcranial direct current stimulation will be administered for 20 minutes using a CE approved stimulator (NeuroConn, Ilmenau, Germany).
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 right dorsolateral prefrontal cortex and one cathodal electrode (100cm2) will be placed over the left supraorbital area at least 5cm from the anode. 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 20 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.
Number of balloon pumps in the Balloon Analogue Risk Task after stimulation
The number of balloon pumps, measured by the number of times subjects press a button to pump up a computerized balloon over 60 trials, will be assessed.
Measured: Within 1 hour after the 20-minute tDCS or sham session ends
Neural activity during Balloon Analogue Risk Task after stimulation
Functional brain activity and connectivity will be assessed using functional magnetic resonance imaging.
Measured: Within 1 hour after the 20-minute tDCS or sham session ends
Aggressive behavior after stimulation
This will be assessed according to performance on the violent video game, Carmageddon: TDR 2000 (Klasen et al., 2013; Torus Games, Bayswater, Australia, 2000) in comparison to a modified non-violent version of the game.
Measured: Within 1 hour after the 20-minute tDCS or sham session ends
Neural activity during aggression task after stimulation
Functional brain activity and connectivity during participation in the video game will be assessed using functional magnetic resonance imaging.
Measured: Within 1 hour after the 20-minute tDCS or sham session ends
Antisocial behavior inclinations after stimulation
This will be assessed using 8 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.
Measured: Within 1 hour after the 20-minute tDCS or sham session ends
Secondary outcomes (3)
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 the 20-minute tDCS or sham session ends
Ratings of guilt or shame regarding antisocial acts after stimulation
This will be assessed using 8 hypothetical scenarios in which someone commits a criminal or antisocial act. Participants will respond to the likelihood that they would feel a sense of guilt or shame according to a 10-point Likert scale.
Measured: Within 1 hour after the 20-minute tDCS or sham session ends
Ratings of moral wrongfulness regarding antisocial acts after stimulation
This will be assessed using 8 hypothetical scenarios in which someone commits a criminal or antisocial act. Participants will rate the moral wrongfulness of the acts according to a 10-point Likert scale.
Measured: Within 1 hour after the 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 posted30 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion1 Jun 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olivia Choy
- Sponsor type
- University, hospital or other
- Collaborators
- RWTH Aachen University
- Responsible party
- Sponsor-investigator, Olivia Choy, University of Pennsylvania
- Investigators
- Ute Habel, PhD, Principal investigator, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036683
- Sponsor's protocol ID
- EK 341/16
- Status last verified
- Oct 2022
- First submitted
- 26 Jan 2017
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klasen M, Zvyagintsev M, Schwenzer M, Mathiak KA, Sarkheil P, Weber R, Mathiak K. Quetiapine modulates functional connectivity in brain aggression networks. Neuroimage. 2013 Jul 15;75:20-26. doi: 10.1016/j.neuroimage.2013.02.053. Epub 2013 Mar 7.
PubMed 23501053
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 on Risk-taking and Aggression in Offenders
- ClinicalTrials.gov ID
- NCT03036683
- Acronym / sponsor ID
- EK 341/16
- Conditions
- Aggression, Risk-Taking, Antisocial Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Olivia ChoyUniversity, hospital or other
- Collaborators
- RWTH Aachen University
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 30 Jan 2017 (estimated)
- 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.
This study investigates the effect of upregulating prefrontal cortex activity on risk-taking, and antisocial and aggressive behavior in violent offenders. In the double-blind, randomized controlled trial, using a within-subject crossover design, each participant will undergo anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex and sham stimulation. After each stimulation session, neural activity and behavioral responses to tasks assessing risk-taking and aggressive behavior will be recorded. The effect of tDCS on violent offenders will also be assessed in comparison to age and gender-matched healthy controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 right dorsolateral prefrontal cortex and one cathodal electrode (100cm2) will be placed over the left supraorbital area at least 5cm from the anode. 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 20 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 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18 and 50 years of age
- Able to understand the nature of the study and give informed consent
- Individuals in the violent offender group must have a record of repeated violent criminal offending (at least 2 felonies).
- Individuals in the violent offender group must have been convicted solely due to crimes involving violence motivated by impulsive aggression.
Key exclusion criteria (7 listed)
- Presence of any contraindications for functional magnetic resonance imaging (fMRI)
- History of significant medical illness
- History of any neurological condition
- Diagnosis of schizophrenia
- History of epilepsy
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 stimulationTranscranial direct current stimulation will be administered for 20 minutes using a CE approved stimulator (NeuroConn, Ilmenau, Germany). | 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
Number of balloon pumps in the Balloon Analogue Risk Task after stimulation
Time frame: Within 1 hour after the 20-minute tDCS or sham session ends
The number of balloon pumps, measured by the number of times subjects press a button to pump up a computerized balloon over 60 trials, will be assessed.
Neural activity during Balloon Analogue Risk Task after stimulation
Time frame: Within 1 hour after the 20-minute tDCS or sham session ends
Functional brain activity and connectivity will be assessed using functional magnetic resonance imaging.
Aggressive behavior after stimulation
Time frame: Within 1 hour after the 20-minute tDCS or sham session ends
This will be assessed according to performance on the violent video game, Carmageddon: TDR 2000 (Klasen et al., 2013; Torus Games, Bayswater, Australia, 2000) in comparison to a modified non-violent version of the game.
Neural activity during aggression task after stimulation
Time frame: Within 1 hour after the 20-minute tDCS or sham session ends
Functional brain activity and connectivity during participation in the video game will be assessed using functional magnetic resonance imaging.
Antisocial behavior inclinations after stimulation
Time frame: Within 1 hour after the 20-minute tDCS or sham session ends
This will be assessed using 8 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.
3 secondary outcomes
Number of participants with adverse events
Time frame: Within 1 hour after the 20-minute tDCS or sham session ends
Ratings of guilt or shame regarding antisocial acts after stimulation
Time frame: Within 1 hour after the 20-minute tDCS or sham session ends
Ratings of moral wrongfulness regarding antisocial acts after stimulation
Time frame: Within 1 hour after the 20-minute tDCS or sham session ends
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Background: PubMed 23501053Klasen M, Zvyagintsev M, Schwenzer M, Mathiak KA, Sarkheil P, Weber R, Mathiak K. Quetiapine modulates functional connectivity in brain aggression networks. Neuroimage. 2013 Jul 15;75:20-26. doi: 10.1016/j.neuroimage.2013.02.053. Epub 2013 Mar 7.
- 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.
Ute Habel, PhD principal investigator
RWTH Aachen 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 and Risk-Taking, run by Olivia Choy at 1 site in Germany.
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 4 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 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 balloon pumps in the Balloon Analogue Risk Task after stimulation (time frame: Within 1 hour after the 20-minute tDCS or sham session ends). The study lists 5 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 NCT03036683, 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 18 Oct 2022.