<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03036683</url>
  </required_header>
  <id_info>
    <org_study_id>EK 341/16</org_study_id>
    <nct_id>NCT03036683</nct_id>
  </id_info>
  <brief_title>Transcranial Direct Current Stimulation in Offenders</brief_title>
  <official_title>The Effect of Transcranial Direct Current Stimulation on Risk-taking and Aggression in Offenders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Olivia Choy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RWTH Aachen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the effect of upregulating prefrontal cortex activity on risk-taking,&#xD;
      and antisocial and aggressive behavior in violent offenders. In the double-blind, randomized&#xD;
      controlled trial, using a within-subject crossover design, each participant will undergo&#xD;
      anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex&#xD;
      and sham stimulation. After each stimulation session, neural activity and behavioral&#xD;
      responses to tasks assessing risk-taking and aggressive behavior will be recorded. The effect&#xD;
      of tDCS on violent offenders will also be assessed in comparison to age and gender-matched&#xD;
      healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">June 1, 2022</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of balloon pumps in the Balloon Analogue Risk Task after stimulation</measure>
    <time_frame>Within 1 hour after the 20-minute tDCS or sham session ends</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neural activity during Balloon Analogue Risk Task after stimulation</measure>
    <time_frame>Within 1 hour after the 20-minute tDCS or sham session ends</time_frame>
    <description>Functional brain activity and connectivity will be assessed using functional magnetic resonance imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Aggressive behavior after stimulation</measure>
    <time_frame>Within 1 hour after the 20-minute tDCS or sham session ends</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neural activity during aggression task after stimulation</measure>
    <time_frame>Within 1 hour after the 20-minute tDCS or sham session ends</time_frame>
    <description>Functional brain activity and connectivity during participation in the video game will be assessed using functional magnetic resonance imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antisocial behavior inclinations after stimulation</measure>
    <time_frame>Within 1 hour after the 20-minute tDCS or sham session ends</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Within 1 hour after the 20-minute tDCS or sham session ends</time_frame>
    <description>The number of participants reporting the experience of sensations resulting from tDCS will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratings of guilt or shame regarding antisocial acts after stimulation</measure>
    <time_frame>Within 1 hour after the 20-minute tDCS or sham session ends</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratings of moral wrongfulness regarding antisocial acts after stimulation</measure>
    <time_frame>Within 1 hour after the 20-minute tDCS or sham session ends</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Aggression</condition>
  <condition>Risk-Taking</condition>
  <condition>Antisocial Behavior</condition>
  <arm_group>
    <arm_group_label>Anodal stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial direct current stimulation</intervention_name>
    <description>Transcranial direct current stimulation will be administered for 20 minutes using a CE approved stimulator (NeuroConn, Ilmenau, Germany).</description>
    <arm_group_label>Anodal stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham transcranial direct current stimulation</intervention_name>
    <description>The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.</description>
    <arm_group_label>Sham stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 18 and 50 years of age&#xD;
&#xD;
          -  Able to understand the nature of the study and give informed consent&#xD;
&#xD;
          -  Individuals in the violent offender group must have a record of repeated violent&#xD;
             criminal offending (at least 2 felonies).&#xD;
&#xD;
          -  Individuals in the violent offender group must have been convicted solely due to&#xD;
             crimes involving violence motivated by impulsive aggression.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of any contraindications for functional magnetic resonance imaging (fMRI)&#xD;
&#xD;
          -  History of significant medical illness&#xD;
&#xD;
          -  History of any neurological condition&#xD;
&#xD;
          -  Diagnosis of schizophrenia&#xD;
&#xD;
          -  History of epilepsy&#xD;
&#xD;
          -  Head injury&#xD;
&#xD;
          -  Mental retardation&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ute Habel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RWTH Aachen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uniklinik RWTH Aachen</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>23501053</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>October 17, 2022</last_update_submitted>
  <last_update_submitted_qc>October 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Olivia Choy</investigator_full_name>
    <investigator_title>PhD candidate</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aggression</mesh_term>
    <mesh_term>Antisocial Personality Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03036683
org study id: EK 341/16
nct id: NCT03036683
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: 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
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.
measure: Neural activity during Balloon Analogue Risk Task after stimulation
time frame: Within 1 hour after the 20-minute tDCS or sham session ends
description: Functional brain activity and connectivity will be assessed using functional magnetic resonance imaging.
measure: Aggressive behavior after stimulation
time frame: Within 1 hour after the 20-minute tDCS or sham session ends
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.
measure: Neural activity during aggression task after stimulation
time frame: Within 1 hour after the 20-minute tDCS or sham session ends
description: Functional brain activity and connectivity during participation in the video game will be assessed using functional magnetic resonance imaging.
measure: Antisocial behavior inclinations after stimulation
time frame: Within 1 hour after the 20-minute tDCS or sham session ends
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.
measure: Number of participants with adverse events
time frame: Within 1 hour after the 20-minute tDCS or sham session ends
description: The number of participants reporting the experience of sensations resulting from tDCS will be recorded.
measure: Ratings of guilt or shame regarding antisocial acts after stimulation
time frame: Within 1 hour after the 20-minute tDCS or sham session ends
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.
measure: Ratings of moral wrongfulness regarding antisocial acts after stimulation
time frame: Within 1 hour after the 20-minute tDCS or sham session ends
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.
arm group label: Anodal stimulation
arm group type: Experimental
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 group label: Sham stimulation
arm group type: Sham Comparator
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: Transcranial direct current stimulation
description: Transcranial direct current stimulation will be administered for 20 minutes using a CE approved stimulator (NeuroConn, Ilmenau, Germany).
arm group label: Anodal stimulation
intervention type: Device
intervention name: Sham transcranial direct current stimulation
description: The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.
arm group label: Sham stimulation
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ute Habel, PhD
role: Principal Investigator
affiliation: RWTH Aachen University
facility: 
country: Germany
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.
PMID: 23501053
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Olivia Choy
investigator title: PhD candidate
mesh term: Aggression
mesh term: Antisocial Personality Disorder
sharing ipd: No