<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/NCT02990442</url>
  </required_header>
  <id_info>
    <org_study_id>1938</org_study_id>
    <nct_id>NCT02990442</nct_id>
  </id_info>
  <brief_title>The Effect of Rapid Transcranial Magnetic Stimulation (rTMS) on Aggression in Forensic Patients</brief_title>
  <official_title>The Effect of Rapid Transcranial Magnetic Stimulation (rTMS) on Aggression in Forensic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Joseph's Healthcare Hamilton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Joseph's Healthcare Hamilton</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Forensic patients will undergo 30 rTMS treatments, once per day each business day using a 1Hz&#xD;
      frequency at the right dorso-lateral pre frontal cortex, located using modified BEAM F3.&#xD;
      Patients will be assessed before and after the study with a battery of assessments and using&#xD;
      2 computer tasks: a ball passing task, and the Point Subtraction Aggression Paradigm (PSAP).&#xD;
      The investigators will also monitor and record aggressive incidents that take place on the&#xD;
      unit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Aggressive Incident Scale (AIS)</measure>
    <time_frame>30 days</time_frame>
    <description>ranking scale of aggressive incidents</description>
  </primary_outcome>
  <other_outcome>
    <measure>Change in Ball sharing task score</measure>
    <time_frame>30 days</time_frame>
    <description>computer task</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Point Subtraction Aggression Paradigm (PSAP)</measure>
    <time_frame>30 days</time_frame>
    <description>computer task</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Aggression</condition>
  <arm_group>
    <arm_group_label>rTMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treatment with repetitive transcranial magnetic stimulation for 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>rTMS</intervention_name>
    <description>repetitive transcranial magnetic stimulation, 1Hz protocol to right dorsolateral pre frontal cortex (R_DLPFC)</description>
    <arm_group_label>rTMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. are voluntary and competent to consent to treatment&#xD;
&#xD;
          2. are a current Forensics inpatient at St. Joseph's West 5th Campus&#xD;
&#xD;
          3. demonstrate aggressive behavior as confirmed by a psychologist or psychiatrist&#xD;
             including verbal and physical aggression&#xD;
&#xD;
          4. are between the ages of 18 and 65&#xD;
&#xD;
          5. have had no changes in dose or initiation of any psychotropic medication in the 4&#xD;
             weeks prior to motor threshold&#xD;
&#xD;
          6. are willing and able to adhere to the treatment schedule&#xD;
&#xD;
          7. pass the TMS adult Safety-Screening (TASS) Questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Withdraw consent to participate in the study&#xD;
&#xD;
          2. fail the TASS Safety Screening Questionnaire&#xD;
&#xD;
          3. have a concomitant major unstable medical illness, cardiac pacemaker or implanted&#xD;
             medication pump, or a significant history of seizures&#xD;
&#xD;
          4. have active suicidal intent&#xD;
&#xD;
          5. are pregnant as confirmed by pregnancy test completed as part of pre-study screening&#xD;
&#xD;
          6. have any significant neurological disorder or insult including, but not limited to:&#xD;
             any condition likely to be associated with increased intracranial pressure, space&#xD;
             occupying brain lesion, any significant history of seizure except those&#xD;
             therapeutically induced by electroconvulsive therapy (ECT), cerebral aneurysm,&#xD;
             Parkinson's disease, Huntington's chorea, multiple sclerosis&#xD;
&#xD;
          7. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear&#xD;
             implants, or electrodes) or any other metal object within or near the head, excluding&#xD;
             the mouth, that cannot be safely removed&#xD;
&#xD;
          8. currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent)&#xD;
             due to seizure risk or any dose of an anticonvulsant due to the potential to limit&#xD;
             rTMS efficacy&#xD;
&#xD;
          9. non-correctable clinically significant sensory impairment (i.e., cannot hear well&#xD;
             enough to cooperate with interview).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gary Chaimowitz, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of Forensics</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sheila Verhage-Brown, MD</last_name>
    <phone>905-522-1155</phone>
    <phone_ext>36356</phone_ext>
    <email>sverhage@stjoes.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>St. Joseph's Healthcare Hamilton</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N3K7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sheila Verhage-Brown, MD</last_name>
      <phone>905-522-1155</phone>
      <phone_ext>36356</phone_ext>
      <email>sverhage@stjoes.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>April 18, 2019</last_update_submitted>
  <last_update_submitted_qc>April 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Joseph's Healthcare Hamilton</investigator_affiliation>
    <investigator_full_name>Gary Chaimowitz</investigator_full_name>
    <investigator_title>Head of Forensics</investigator_title>
  </responsible_party>
  <keyword>rTMS</keyword>
  <keyword>Repetitive Transcranial Magnetic Stimulation</keyword>
  <keyword>Brain Stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aggression</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/NCT02990442
org study id: 1938
nct id: NCT02990442
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Forensic patients will undergo 30 rTMS treatments, once per day each business day using a 1Hz
      frequency at the right dorso-lateral pre frontal cortex, located using modified BEAM F3.
      Patients will be assessed before and after the study with a battery of assessments and using
      2 computer tasks: a ball passing task, and the Point Subtraction Aggression Paradigm (PSAP).
      The investigators will also monitor and record aggressive incidents that take place on the
      unit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Aggressive Incident Scale (AIS)
time frame: 30 days
description: ranking scale of aggressive incidents
measure: Change in Ball sharing task score
time frame: 30 days
description: computer task
measure: Change in Point Subtraction Aggression Paradigm (PSAP)
time frame: 30 days
description: computer task
arm group label: rTMS
arm group type: Experimental
description: treatment with repetitive transcranial magnetic stimulation for 30 days
intervention type: Device
intervention name: rTMS
description: repetitive transcranial magnetic stimulation, 1Hz protocol to right dorsolateral pre frontal cortex (R_DLPFC)
arm group label: rTMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Gary Chaimowitz, MD, FRCPC
role: Principal Investigator
affiliation: Head of Forensics
last name: Sheila Verhage-Brown, MD
phone: 905-522-1155
phone ext: 36356
email: sverhage@stjoes.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Joseph's Healthcare Hamilton
investigator full name: Gary Chaimowitz
investigator title: Head of Forensics
mesh term: Aggression
sharing ipd: No