<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/NCT02205918</url>
  </required_header>
  <id_info>
    <org_study_id>PSYCH-2017-25550</org_study_id>
    <nct_id>NCT02205918</nct_id>
  </id_info>
  <brief_title>Brain-Behavior Interactions in Tic Suppression</brief_title>
  <official_title>Integrative Examination of Neurobehavioral Mechanisms in Tic Suppression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine how the brain and environment interact to influence&#xD;
      children's ability to suppress tics using a medical technology called Transcranial Magnetic&#xD;
      Stimulation (TMS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: This study will recruit youth with chronic tics. Chronic tics are the most common&#xD;
      movement disorder in children. The goal of the study is to learn how the brain and&#xD;
      environment influence children's ability to suppress tics. Specifically, we want to learn how&#xD;
      tics are influenced by a certain part of the brain called the supplementary motor area (SMA).&#xD;
      This part of the brain is thought to be more active in people with tics. This will be the&#xD;
      first study to look at the relationship between SMA, tic suppression, and urges to tic.&#xD;
&#xD;
      Research Procedures: The study will take place over the course of three days within a week&#xD;
      (about 5 hours total). The study will examine the relationship between the SMA and tic&#xD;
      suppression using a non-invasive medical technology called Transcranial Magnetic Stimulation&#xD;
      (TMS). Participants will have a diagnostic interview, MRI brain scan (used to find the&#xD;
      location of the SMA), and TMS. Participants will be asked to try to suppress tics before and&#xD;
      after TMS. The information that will be collected from participation includes information&#xD;
      about tic symptoms, emotional and behavioral functioning, and brain activity (from MRI brain&#xD;
      images and TMS results).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tic frequency</measure>
    <time_frame>Day 3</time_frame>
    <description>Tics will be observed and counted</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urge to tic</measure>
    <time_frame>Day 3</time_frame>
    <description>The participant will be asked to give subjective ratings of premonitory urge intensity</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Tourette's Syndrome</condition>
  <condition>Chronic Motor Tic Disorder</condition>
  <condition>Chronic Vocal Tic Disorder</condition>
  <arm_group>
    <arm_group_label>Sham TMS</arm_group_label>
    <description>Participants in this group will receive one, 30 minute session of inactive (&quot;sham&quot;) TMS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active TMS</arm_group_label>
    <description>Participants in this group will receive one, 30 minute session of 1hz TMS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active TMS</intervention_name>
    <description>There will be one, 30-minute TMS session. Participants randomly assigned to this group will receive 1hz &quot;active&quot; TMS. Tics and urges will be monitored immediately before and after TMS.</description>
    <arm_group_label>Active TMS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham TMS</intervention_name>
    <description>There will be one, 30-minute TMS session. Participants randomly assigned to this group will receive inactive (&quot;sham&quot;) TMS. Tics and urges will be monitored immediately before and after TMS.</description>
    <arm_group_label>Sham TMS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Community sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of motor and/or vocal tics for at least one year&#xD;
&#xD;
          -  English fluency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with medical conditions that are contraindicated for TMS (history of any&#xD;
             known intracranial pathology, epilepsy or seizures, traumatic brain injury, brain&#xD;
             tumor, stroke, implanted medical devices, current pregnancy or girls of childbearing&#xD;
             age not using effective contraception, or any other serious medical conditions&#xD;
&#xD;
          -  Left-handedness&#xD;
&#xD;
          -  Previous diagnosis of psychosis, autism spectrum disorder, mental retardation, or&#xD;
             cognitive disability&#xD;
&#xD;
          -  Inability to undergo MRI&#xD;
&#xD;
          -  Substance abuse or dependence within the past year&#xD;
&#xD;
          -  History of ≥3 sessions of Habit Reversal Therapy or other treatment primarily&#xD;
             comprised of tic suppression strategies&#xD;
&#xD;
          -  Current suicidal intent&#xD;
&#xD;
          -  Current neuroleptic medications, as these medications are known to lower seizure&#xD;
             threshold&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Conelea, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tourette Syndrome</mesh_term>
    <mesh_term>Tics</mesh_term>
    <mesh_term>Tic Disorders</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/NCT02205918
org study id: PSYCH-2017-25550
nct id: NCT02205918
lead sponsor: 
has dmc: Yes
The purpose of this study is to examine how the brain and environment interact to influence
      children's ability to suppress tics using a medical technology called Transcranial Magnetic
      Stimulation (TMS).
Objectives: This study will recruit youth with chronic tics. Chronic tics are the most common
      movement disorder in children. The goal of the study is to learn how the brain and
      environment influence children's ability to suppress tics. Specifically, we want to learn how
      tics are influenced by a certain part of the brain called the supplementary motor area (SMA).
      This part of the brain is thought to be more active in people with tics. This will be the
      first study to look at the relationship between SMA, tic suppression, and urges to tic.

      Research Procedures: The study will take place over the course of three days within a week
      (about 5 hours total). The study will examine the relationship between the SMA and tic
      suppression using a non-invasive medical technology called Transcranial Magnetic Stimulation
      (TMS). Participants will have a diagnostic interview, MRI brain scan (used to find the
      location of the SMA), and TMS. Participants will be asked to try to suppress tics before and
      after TMS. The information that will be collected from participation includes information
      about tic symptoms, emotional and behavioral functioning, and brain activity (from MRI brain
      images and TMS results).
observational model: Case-Only
time perspective: Cross-Sectional
measure: Tic frequency
time frame: Day 3
description: Tics will be observed and counted
measure: Urge to tic
time frame: Day 3
description: The participant will be asked to give subjective ratings of premonitory urge intensity
arm group label: Sham TMS
description: Participants in this group will receive one, 30 minute session of inactive ("sham") TMS.
arm group label: Active TMS
description: Participants in this group will receive one, 30 minute session of 1hz TMS.
intervention type: Other
intervention name: Active TMS
description: There will be one, 30-minute TMS session. Participants randomly assigned to this group will receive 1hz "active" TMS. Tics and urges will be monitored immediately before and after TMS.
arm group label: Active TMS
intervention type: Other
intervention name: Sham TMS
description: There will be one, 30-minute TMS session. Participants randomly assigned to this group will receive inactive ("sham") TMS. Tics and urges will be monitored immediately before and after TMS.
arm group label: Sham TMS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Christine Conelea, PhD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tourette Syndrome
mesh term: Tics
mesh term: Tic Disorders
sharing ipd: No