<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/NCT03265015</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19090219 (Part 1)</org_study_id>
    <secondary_id>R21MH112770</secondary_id>
    <nct_id>NCT03265015</nct_id>
  </id_info>
  <brief_title>Theta Burst Stimulation for Compulsive Behavior Non-invasive Brain Stimulation Study</brief_title>
  <official_title>Testing the Causal Role of Orbitofrontal Cortex in Human Compulsive Behavior: a Non-invasive Brain Stimulation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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>
      This project seeks to identify causal neural mechanisms underlying unwanted, repetitive&#xD;
      behaviors (compulsions). Using non-invasive brain stimulation coupled with practice in a&#xD;
      computer task, we will modulate activity in a target brain region in two directions (up or&#xD;
      down) and measure effects on compulsive behaviors and related measures. This work could&#xD;
      ultimately lead to the ability to treat compulsions more effectively by targeting the regions&#xD;
      of the brain that can help or hinder attempts to overcome compulsions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>functional Magnetic Resonance Imaging (fMRI)</measure>
    <time_frame>10-60min</time_frame>
    <description>Brain activation in target region</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effort to resist compulsive behaviors in response to laboratory triggers</measure>
    <time_frame>90min-1 week</time_frame>
    <description>Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported effort needed to resist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of compulsive behaviors in response to laboratory triggers</measure>
    <time_frame>90min-1 week</time_frame>
    <description>Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of urges to perform compulsive behaviors in response to laboratory triggers</measure>
    <time_frame>90min-1 week</time_frame>
    <description>Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Two-step task</measure>
    <time_frame>90min-1 week</time_frame>
    <description>Neuropsychological test of flexible goal-directed cognition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Yale-Brown Obsessive Compulsive Scale (Y-BOCS)</measure>
    <time_frame>1 week</time_frame>
    <description>Clinician-administered measurement of obsessions and compulsions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHO Disability Assessment Scale 2.0</measure>
    <time_frame>1 week</time_frame>
    <description>Self-report measure of general functioning and disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obsessive Compulsive Inventory-Revised (OCI-R)</measure>
    <time_frame>1 week</time_frame>
    <description>Self-report measure of obsessions and compulsions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Habit override task</measure>
    <time_frame>1 week</time_frame>
    <description>Percentage of correct responses to each stimulus (0-100%; higher score=better performance)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Compulsive Behavior</condition>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>cTBS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>iTBS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transcranial Magnetic Stimulation delivered in an intermittent Theta Burst Stimulation (iTBS) pattern.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Habit Override Practice</intervention_name>
    <description>Computerized &quot;brain training&quot; to provide practice in overriding avoidance habits.</description>
    <arm_group_label>cTBS</arm_group_label>
    <arm_group_label>iTBS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transcranial Magnetic Stimulation</intervention_name>
    <description>Non-invasive method for temporary, focal stimulation of brain areas.</description>
    <arm_group_label>cTBS</arm_group_label>
    <arm_group_label>iTBS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants will:&#xD;
&#xD;
          1. Be between the ages of 18 and 55 years&#xD;
&#xD;
          2. Endorse problematic compulsive behaviors, per self-report and clinician-administered&#xD;
             measures.&#xD;
&#xD;
          3. Agree to video taping of structured clinical interview&#xD;
&#xD;
          4. Report that they will reside in the Pittsburgh area for at least 5 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Failure to meet standard MRI inclusion criteria: those who endorse claustrophobia,&#xD;
             those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or&#xD;
             blood vessels, surgically implanted metal plates, screws or pins, cochlear implants,&#xD;
             implanted uterine devices, metal braces, or other metal objects in their body,&#xD;
             especially in the eye. Dental fillings do not present a problem. Plastic or removable&#xD;
             dental appliances do not require exclusion. History of significant injury or surgery&#xD;
             to the brain or spinal cord that would impair interpretation of results. Pregnancy,&#xD;
             determined by pregnancy tests on females.&#xD;
&#xD;
          2. Medical contraindications for Transcranial Magnetic Stimulation (TMS):&#xD;
&#xD;
               1. Presence of a neurologic disorder or medication therapy known to alter seizure&#xD;
                  threshold (e.g., stroke, aneurysm, brain surgery, structural brain lesion, brain&#xD;
                  injury, frequent/severe headaches)&#xD;
&#xD;
               2. Recurrent seizures or epilepsy in participant or family history of hereditary&#xD;
                  epilepsy&#xD;
&#xD;
               3. Pregnancy&#xD;
&#xD;
               4. Metallic implants in body or other devices that may be affected by magnetic field&#xD;
&#xD;
               5. Significant heart disease or cerebrovascular disease&#xD;
&#xD;
               6. Medications with seizure threshold lowering potential, e.g., clomipramine,&#xD;
                  Monoamine Oxidase inhibitors (MAOi's), imipramine, clozapine&#xD;
&#xD;
          3. Acute suicidality or other psychiatric crises requiring treatment escalation&#xD;
&#xD;
          4. Changes made to treatment regimen within 4 weeks of baseline assessment&#xD;
&#xD;
          5. Reading level &lt;6th grade&#xD;
&#xD;
          6. Presence of bipolar, psychotic, autism spectrum, or substance use disorder (i.e.&#xD;
             current use of mood altering drugs such as cocaine, cannabis or marijuana, opiates,&#xD;
             amphetamines, and barbiturates)&#xD;
&#xD;
          7. Presence of movement disorder or tics affecting manual responses&#xD;
&#xD;
          8. Inability to read text from 2 feet away (corrective lenses allowed)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Western Psychiatric Institute and Clinic</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 14, 2022</last_update_submitted>
  <last_update_submitted_qc>August 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Rebecca Price</investigator_full_name>
    <investigator_title>Assistant Professor of Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
    <mesh_term>Compulsive Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data sharing and make use of NIMH databases.</ipd_description>
  </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/NCT03265015
org study id: STUDY19090219 (Part 1)
secondary id: R21MH112770
nct id: NCT03265015
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project seeks to identify causal neural mechanisms underlying unwanted, repetitive
      behaviors (compulsions). Using non-invasive brain stimulation coupled with practice in a
      computer task, we will modulate activity in a target brain region in two directions (up or
      down) and measure effects on compulsive behaviors and related measures. This work could
      ultimately lead to the ability to treat compulsions more effectively by targeting the regions
      of the brain that can help or hinder attempts to overcome compulsions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: functional Magnetic Resonance Imaging (fMRI)
time frame: 10-60min
description: Brain activation in target region
measure: Effort to resist compulsive behaviors in response to laboratory triggers
time frame: 90min-1 week
description: Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported effort needed to resist
measure: Duration of compulsive behaviors in response to laboratory triggers
time frame: 90min-1 week
description: Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance
measure: Intensity of urges to perform compulsive behaviors in response to laboratory triggers
time frame: 90min-1 week
description: Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity
measure: Two-step task
time frame: 90min-1 week
description: Neuropsychological test of flexible goal-directed cognition
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
time frame: 1 week
description: Clinician-administered measurement of obsessions and compulsions
measure: WHO Disability Assessment Scale 2.0
time frame: 1 week
description: Self-report measure of general functioning and disability
measure: Obsessive Compulsive Inventory-Revised (OCI-R)
time frame: 1 week
description: Self-report measure of obsessions and compulsions
measure: Habit override task
time frame: 1 week
description: Percentage of correct responses to each stimulus (0-100%; higher score=better performance)
arm group label: cTBS
arm group type: Experimental
description: Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern.
arm group label: iTBS
arm group type: Active Comparator
description: Transcranial Magnetic Stimulation delivered in an intermittent Theta Burst Stimulation (iTBS) pattern.
intervention type: Behavioral
intervention name: Habit Override Practice
description: Computerized "brain training" to provide practice in overriding avoidance habits.
arm group label: cTBS
arm group label: iTBS
intervention type: Other
intervention name: Transcranial Magnetic Stimulation
description: Non-invasive method for temporary, focal stimulation of brain areas.
arm group label: cTBS
arm group label: iTBS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Rebecca Price
investigator title: Assistant Professor of Psychiatry
mesh term: Obsessive-Compulsive Disorder
mesh term: Compulsive Behavior
sharing ipd: Yes
ipd description: We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data sharing and make use of NIMH databases.