Transcranial Direct Current Stimulation in Offenders

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.

Study Overview

• Status: Completed
• Conditions: Aggression; Risk-Taking; Antisocial Behavior
• Intervention / Treatment: Device: Transcranial direct current stimulation; Device: Sham transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Uniklinik RWTH Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Anodal stimulation; 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.	Device: Transcranial direct current stimulation; Transcranial direct current stimulation will be administered for 20 minutes using a CE approved stimulator (NeuroConn, Ilmenau, Germany).
SHAM_COMPARATOR: Sham stimulation; 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.	Device: Sham transcranial direct current stimulation; The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Within 1 hour after the 20-minute tDCS or sham session ends

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	The number of participants reporting the experience of sensations resulting from tDCS will be recorded.	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.	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.	Within 1 hour after the 20-minute tDCS or sham session ends

Collaborators and Investigators

• Sponsor: Olivia Choy
• Collaborators: RWTH Aachen University
• Investigators: Principal Investigator: Ute Habel, PhD, RWTH Aachen University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): June 1, 2022

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (ESTIMATE): January 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Personality Disorders; Aggression; Antisocial Personality Disorder
• Other Study ID Numbers: EK 341/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No