<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/NCT04498364</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00256962</org_study_id>
    <nct_id>NCT04498364</nct_id>
  </id_info>
  <brief_title>Extinction Learning in Adults With Tourette Syndrome</brief_title>
  <official_title>Extinction Learning in Adults With Tourette Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</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>
      Aversive sensory phenomena such as premonitory urges play a central role in the behavioral&#xD;
      treatment model of tics. Extinction learning and extinction recall are learning processes&#xD;
      implicated within this model, but are still understudied for individuals with Tourette&#xD;
      syndrome (TS). This study examines extinction learning and extinction recall in adults with&#xD;
      TS using an experimental task. This study will also explore the relationship between&#xD;
      extinction processes (i.e., extinction learning and extinction recall) and treatment outcomes&#xD;
      with behavior therapy. Findings from this investigation will be used to update the behavioral&#xD;
      treatment model, which serves as the basis for evidence-based behavioral interventions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 18, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</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>Tic severity as assessed by the Hopkins Motor and Vocal Tic Scale (HM/VTS)</measure>
    <time_frame>Within 1 week after completion of HRT</time_frame>
    <description>Patient will nominate up to five motor and five vocal tics they deem bothersome on the HM/VTS. Each bothersome tic is then rated by a clinician on the composite two (vocal and motor) 5-point HM/VTS scale ranging from none (0) to severe (4) for the motor as well as vocal tics. The individual tic scores are summed (minimum of 0 and maximum of 40) and averaged together to create an average tic severity score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tic severity as assessed by the Yale Global Tic Severity Scale-Revised (YGTSS)</measure>
    <time_frame>Within 1 week after completion of HRT</time_frame>
    <description>The YGTSS is a clinician-rated semi-structured interview that measures tic symptom severity over the previous week. It consists of 10-items that assess different dimensions of tic severity for motor and vocal tics, which are rated on a 0-5 scale. The YGTSS produces a Total Tic Score (range: 0-50), with higher ratings indicating greater tic severity. The YGTSS has demonstrated treatment sensitivity to pharmacotherapy and behavioral interventions.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Tourette Syndrome</condition>
  <condition>Habit Reversal Training</condition>
  <condition>Tic Disorders</condition>
  <condition>Tics</condition>
  <condition>Comprehensive Behavioral Intervention for Tics</condition>
  <arm_group>
    <arm_group_label>Habit Reversal Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics. It will be delivered over 8 hours of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Habit Reversal Training</intervention_name>
    <description>Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics.</description>
    <arm_group_label>Habit Reversal Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years old,&#xD;
&#xD;
          -  Have moderate tic severity or greater as evidenced by a YGTSS Total Tic Score greater&#xD;
             than 13 (&gt;9 for youth with motor or vocal tics only)&#xD;
&#xD;
          -  Have not received more than 4 previous sessions of HRT&#xD;
&#xD;
          -  Be fluent in English&#xD;
&#xD;
          -  Medication free or on a stable dose of psychiatric medication for 8 weeks prior to&#xD;
             enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An inability to complete rating scales&#xD;
&#xD;
          -  An inability to attend study visits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph F McGuire, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicholas Myers</last_name>
    <phone>4432877157</phone>
    <email>coach@jhmi.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Johns Hopkins University School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicholas Myers, M.A</last_name>
      <phone>443-287-7157</phone>
      <email>coach@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Joseph McGuire, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Extinction Learning</keyword>
  <keyword>Comprehensive Behavioral Intervention for Tics</keyword>
  <keyword>Behavior Therapy</keyword>
  <keyword>Habit Reversal Training</keyword>
  <keyword>Tourette's Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tourette Syndrome</mesh_term>
    <mesh_term>Tic Disorders</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04498364
org study id: IRB00256962
nct id: NCT04498364
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aversive sensory phenomena such as premonitory urges play a central role in the behavioral
      treatment model of tics. Extinction learning and extinction recall are learning processes
      implicated within this model, but are still understudied for individuals with Tourette
      syndrome (TS). This study examines extinction learning and extinction recall in adults with
      TS using an experimental task. This study will also explore the relationship between
      extinction processes (i.e., extinction learning and extinction recall) and treatment outcomes
      with behavior therapy. Findings from this investigation will be used to update the behavioral
      treatment model, which serves as the basis for evidence-based behavioral interventions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tic severity as assessed by the Hopkins Motor and Vocal Tic Scale (HM/VTS)
time frame: Within 1 week after completion of HRT
description: Patient will nominate up to five motor and five vocal tics they deem bothersome on the HM/VTS. Each bothersome tic is then rated by a clinician on the composite two (vocal and motor) 5-point HM/VTS scale ranging from none (0) to severe (4) for the motor as well as vocal tics. The individual tic scores are summed (minimum of 0 and maximum of 40) and averaged together to create an average tic severity score.
measure: Tic severity as assessed by the Yale Global Tic Severity Scale-Revised (YGTSS)
time frame: Within 1 week after completion of HRT
description: The YGTSS is a clinician-rated semi-structured interview that measures tic symptom severity over the previous week. It consists of 10-items that assess different dimensions of tic severity for motor and vocal tics, which are rated on a 0-5 scale. The YGTSS produces a Total Tic Score (range: 0-50), with higher ratings indicating greater tic severity. The YGTSS has demonstrated treatment sensitivity to pharmacotherapy and behavioral interventions.
arm group label: Habit Reversal Training
arm group type: Experimental
description: Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics. It will be delivered over 8 hours of treatment.
intervention type: Behavioral
intervention name: Habit Reversal Training
description: Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics.
arm group label: Habit Reversal Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph F McGuire, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Nicholas Myers
phone: 4432877157
email: coach@jhmi.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Tourette Syndrome
mesh term: Tic Disorders
mesh term: Syndrome
sharing ipd: Undecided