Transcranial Direct Current Stimulation in Offenders

NCT03036683 | Completed

• 1 other identifier: EK 341/16
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aggression; Risk-Taking; Antisocial Behavior

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Number of participants with adverse events

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

• Ratings of guilt or shame regarding antisocial acts after stimulation

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

• Ratings of moral wrongfulness regarding antisocial acts after stimulation

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

Study Arms (2)

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.

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.

Device: Sham transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

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

Anodal stimulation

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.

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Olivia Choy: lead
• RWTH Aachen University: collaborator

Study Sites (1)

Uniklinik RWTH Aachen

Aachen, 52074, Germany

Location

Related Publications (1)

• 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.

  PMID: 23501053 BACKGROUND

MeSH Terms

Conditions

Aggression; Risk-Taking; Antisocial Personality Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Ute Habel, PhD

  RWTH Aachen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 30, 2017
• Study Start: February 1, 2017
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)