Transcranial Direct Current Stimulation in Offenders

Aggression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036683
• Other study ID #: EK 341/16
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Antisocial Behavior
• Antisocial Personality Disorder
• Risk-Taking

Intervention

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

Locations

Country	Name	City	State
Germany	Uniklinik RWTH Aachen	Aachen

Sponsors (2)

Lead Sponsor	Collaborator
Olivia Choy	RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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