Transcranial Direct Current Stimulation in Offenders (NCT03036683) | Clinical Trial Compass
CompletedNot Applicable
Transcranial Direct Current Stimulation in Offenders
Germany41 participantsStarted 2017-02-01
Plain-language 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 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.
Who can participate
Age range
18 Years – 50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of balloon pumps in the Balloon Analogue Risk Task after stimulation
Timeframe: Within 1 hour after the 20-minute tDCS or sham session ends
2
Neural activity during Balloon Analogue Risk Task after stimulation
Timeframe: Within 1 hour after the 20-minute tDCS or sham session ends
3
Aggressive behavior after stimulation
Timeframe: Within 1 hour after the 20-minute tDCS or sham session ends
4
Neural activity during aggression task after stimulation
Timeframe: Within 1 hour after the 20-minute tDCS or sham session ends
5
Antisocial behavior inclinations after stimulation
Timeframe: Within 1 hour after the 20-minute tDCS or sham session ends