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Completed

NCT Number: NCT03036683

Transcranial Direct Current Stimulation 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.

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Key information

Conditions

Aggression Aberrant Motor Behavior in Dementia Antisocial Behavior Antisocial Personality Disorder Behavior Behavioral Symptoms Mental Disorders Personality Disorders Risk-Taking Social Behavior

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Uniklinik RWTH Aachen

Aachen, 52074, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Transcranial direct current stimulation will be administered for 20 minutes using a CE approved stimulator (NeuroConn, Ilmenau, Germany).

Sham Transcranial Direct Current Stimulation

Device

The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: Within 1 hour after the 20-minute tDCS or sham session ends

    The number of participants reporting the experience of sensations resulting from tDCS will be recorded.

  2. Ratings of guilt or shame regarding antisocial acts 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 feel a sense of guilt or shame according to a 10-point Likert scale.

  3. Ratings of moral wrongfulness regarding antisocial acts 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 rate the moral wrongfulness of the acts according to a 10-point Likert scale.

Sponsors and collaborators

Lead sponsor

Olivia Choy

Other

Collaborators

  • RWTH Aachen University

Registry information

Official study title

The Effect of Transcranial Direct Current Stimulation on Risk-taking and Aggression in Offenders

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Jan 30, 2017
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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