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Transcranial Direct Current Stimulation in Offenders

Primary Purpose

Aggression, Risk-Taking, Antisocial Behavior

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sham transcranial direct current stimulation
Sponsored by
Olivia Choy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Aggression

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Uniklinik RWTH Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Anodal stimulation

Sham stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Neural activity during Balloon Analogue Risk Task after stimulation
Functional brain activity and connectivity will be assessed using functional magnetic resonance imaging.
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.
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.
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.

Secondary Outcome Measures

Number of participants with adverse events
The number of participants reporting the experience of sensations resulting from tDCS will be recorded.
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.
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.

Full Information

First Posted
January 26, 2017
Last Updated
October 17, 2022
Sponsor
Olivia Choy
Collaborators
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT03036683
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olivia Choy
Collaborators
RWTH Aachen University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggression, Risk-Taking, Antisocial Behavior

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anodal stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
Transcranial direct current stimulation will be administered for 20 minutes using a CE approved stimulator (NeuroConn, Ilmenau, Germany).
Intervention Type
Device
Intervention Name(s)
Sham transcranial direct current stimulation
Intervention Description
The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.
Primary Outcome Measure Information:
Title
Number of balloon pumps in the Balloon Analogue Risk Task after stimulation
Description
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.
Time Frame
Within 1 hour after the 20-minute tDCS or sham session ends
Title
Neural activity during Balloon Analogue Risk Task after stimulation
Description
Functional brain activity and connectivity will be assessed using functional magnetic resonance imaging.
Time Frame
Within 1 hour after the 20-minute tDCS or sham session ends
Title
Aggressive behavior after stimulation
Description
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.
Time Frame
Within 1 hour after the 20-minute tDCS or sham session ends
Title
Neural activity during aggression task after stimulation
Description
Functional brain activity and connectivity during participation in the video game will be assessed using functional magnetic resonance imaging.
Time Frame
Within 1 hour after the 20-minute tDCS or sham session ends
Title
Antisocial behavior inclinations after stimulation
Description
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.
Time Frame
Within 1 hour after the 20-minute tDCS or sham session ends
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Description
The number of participants reporting the experience of sensations resulting from tDCS will be recorded.
Time Frame
Within 1 hour after the 20-minute tDCS or sham session ends
Title
Ratings of guilt or shame regarding antisocial acts after stimulation
Description
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.
Time Frame
Within 1 hour after the 20-minute tDCS or sham session ends
Title
Ratings of moral wrongfulness regarding antisocial acts after stimulation
Description
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.
Time Frame
Within 1 hour after the 20-minute tDCS or sham session ends

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ute Habel, PhD
Organizational Affiliation
RWTH Aachen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniklinik RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23501053
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.
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Transcranial Direct Current Stimulation in Offenders

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