Clinical trial NCT03036683: Transcranial Direct Current Stimulation in Offenders
Official title: The Effect of Transcranial Direct Current Stimulation on Risk-taking and Aggression in Offenders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aggression
Risk-Taking
Antisocial Behavior
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: RWTH Aachen University
First posted: 2017-01-30
Enrollment: 41
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: Neural activity during Balloon Analogue Risk Task after stimulation
timeFrame: Within 1 hour after the 20-minute tDCS or sham session ends
measure: Aggressive behavior after stimulation
timeFrame: Within 1 hour after the 20-minute tDCS or sham session ends
measure: Neural activity during aggression task after stimulation
timeFrame: Within 1 hour after the 20-minute tDCS or sham session ends
measure: Antisocial behavior inclinations after stimulation
timeFrame: Within 1 hour after the 20-minute tDCS or sham session ends
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Within 1 hour after the 20-minute tDCS or sham session ends
measure: Ratings of guilt or shame regarding antisocial acts after stimulation
timeFrame: Within 1 hour after the 20-minute tDCS or sham session ends
measure: Ratings of moral wrongfulness regarding antisocial acts after stimulation
timeFrame: Within 1 hour after the 20-minute tDCS or sham session ends
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
Study officials:
affiliation: RWTH Aachen University
name: Ute Habel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.