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Transcranial Direct Current Stimulation in Offenders

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ClinicalTrials.gov Identifier: NCT03036683
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
RWTH Aachen University
Information provided by (Responsible Party):
Olivia Choy, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Aggression Risk-Taking Antisocial Behavior Device: Transcranial direct current stimulation Device: Sham transcranial direct current stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Transcranial Direct Current Stimulation on Risk-taking and Aggression in Offenders
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2020

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.




Primary Outcome Measures :
  1. Number of balloon pumps in the Balloon Analogue Risk Task after stimulation [ Time Frame: Within 1 hour after the 20-minute tDCS or sham session ends ]
    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.

  2. Neural activity during Balloon Analogue Risk Task after stimulation [ Time Frame: Within 1 hour after the 20-minute tDCS or sham session ends ]
    Functional brain activity and connectivity will be assessed using functional magnetic resonance imaging.

  3. Aggressive behavior after stimulation [ Time Frame: Within 1 hour after the 20-minute tDCS or sham session ends ]
    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.

  4. Neural activity during aggression task after stimulation [ Time Frame: Within 1 hour after the 20-minute tDCS or sham session ends ]
    Functional brain activity and connectivity during participation in the video game will be assessed using functional magnetic resonance imaging.

  5. Antisocial behavior inclinations after stimulation [ Time Frame: Within 1 hour after the 20-minute tDCS or sham session ends ]
    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 :
  1. Number of participants with adverse events [ Time Frame: Within 1 hour after the 20-minute tDCS or sham session ends ]
    The number of participants reporting the experience of sensations resulting from tDCS will be recorded.

  2. Ratings of guilt or shame regarding antisocial acts after stimulation [ Time Frame: Within 1 hour after the 20-minute tDCS or sham session ends ]
    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.

  3. Ratings of moral wrongfulness regarding antisocial acts after stimulation [ Time Frame: Within 1 hour after the 20-minute tDCS or sham session ends ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036683


Locations
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Germany
Uniklinik RWTH Aachen
Aachen, Germany, 52074
Sponsors and Collaborators
Olivia Choy
RWTH Aachen University
Investigators
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Principal Investigator: Ute Habel, PhD RWTH Aachen University

Publications:
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Responsible Party: Olivia Choy, PhD candidate, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03036683     History of Changes
Other Study ID Numbers: EK 341/16
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Aggression
Behavioral Symptoms