xml: <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/NCT06016673</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00003574</org_study_id>
      <nct_id>NCT06016673</nct_id>
    </id_info>
    <brief_title>Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)</brief_title>
    <official_title>Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Florida State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Florida State 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>
        Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of the present study is to examine the effects of transcranial magnetic&#xD;
        stimulation (TMS) on cognitive control among individuals with posttraumatic stress disorder&#xD;
        (PTSD).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 13, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</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>
      <intervention_model_description>Each participant will receive stimulation to two brain areas (right dorsolateral prefrontal cortex and vertex) in a counterbalanced order.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Performance on emotional working memory task</measure>
      <time_frame>5 hours</time_frame>
      <description>Accuracy and reaction time on a task measuring working memory in the presence of trauma-related distractor images</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">35</enrollment>
    <condition>PTSD</condition>
    <arm_group>
      <arm_group_label>Intermittent theta burst stimulation to right dorsolateral prefrontal cortex</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive intermittent theta burst stimulation (iTBS) to the experimental target area, the right dorsolateral prefrontal cortex (rDLPFC)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intermittent theta burst stimulation to vertex of the skull</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive intermittent theta burst stimulation (iTBS) to the active comparator area, the vertex of the skull</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Transcranial Magnetic Stimulation (TMS)</intervention_name>
      <description>Participants will receive intermittent theta burst stimulation (iTBS) to two brain areas, the right dorsolateral prefrontal cortex (rDLPFC) and the vertex.</description>
      <arm_group_label>Intermittent theta burst stimulation to right dorsolateral prefrontal cortex</arm_group_label>
      <arm_group_label>Intermittent theta burst stimulation to vertex of the skull</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Over 18 years of age&#xD;
  &#xD;
            -  Endorse lifetime exposure to at least one Criterion A traumatic event&#xD;
  &#xD;
            -  Report clinically significant posttraumatic stress disorder (PTSD) symptoms (score of&#xD;
               ≥ 33 on the PTSD Checklist for DSM-5 [PCL-5]).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Endorse medical contraindication for neuromodulation (e.g., ferrous metal in head,&#xD;
               seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)&#xD;
  &#xD;
            -  Report an unstable medical condition or any current medical condition that precludes&#xD;
               safe participation in the trial (e.g., unstable metabolic abnormality, unstable&#xD;
               angina, etc.)&#xD;
  &#xD;
            -  Report any history or diagnosis of dementia or other cognitive disorder, which may&#xD;
               interfere with engagement&#xD;
  &#xD;
            -  Report any history or diagnosis of Severe Traumatic Brain Injury&#xD;
  &#xD;
            -  Report any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional&#xD;
               Disorder or other psychotic illness, which precludes safe participation in the trial&#xD;
  &#xD;
            -  Report a primary obsessive-compulsive disorder (OCD) diagnosis&#xD;
  &#xD;
            -  Report an active substance use disorder (within last 3 months) or any current&#xD;
               substance use that precludes safe participation in the trial&#xD;
  &#xD;
            -  Report suicide risk that precludes safe participation in the trial, defined as&#xD;
               clinical impression that the participant is at significant risk for suicide (i.e.,&#xD;
               greater than moderate level of suicide risk, in accordance with the Joiner et al.&#xD;
               (1999) suicide risk framework)&#xD;
  &#xD;
            -  Report an inability to stop taking any medication that significantly lowers the&#xD;
               seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)&#xD;
  &#xD;
            -  Report a current, planned, or suspected pregnancy&#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>Norman B Schmidt, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Distinguished Research Professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Norman B Schmidt, PhD</last_name>
      <phone>(850) 645-1766</phone>
      <email>abhcfsu@psy.fsu.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Florida State University College of Medicine</name>
        <address>
          <city>Tallahassee</city>
          <state>Florida</state>
          <zip>32306</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alecia LaPointe</last_name>
        <phone>850-644-1889</phone>
        <email>alecia.lapointe@med.fsu.edu</email>
      </contact>
      <investigator>
        <last_name>Carter E Bedford, MS</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>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Florida State University</investigator_affiliation>
      <investigator_full_name>Carter Bedford</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Transcranial Magnetic Stimulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016673
  org study id: STUDY00003574
  nct id: NCT06016673
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)
  The purpose of the present study is to examine the effects of transcranial magnetic
        stimulation (TMS) on cognitive control among individuals with posttraumatic stress disorder
        (PTSD).
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Each participant will receive stimulation to two brain areas (right dorsolateral prefrontal cortex and vertex) in a counterbalanced order.
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Performance on emotional working memory task
  time frame: 5 hours
  description: Accuracy and reaction time on a task measuring working memory in the presence of trauma-related distractor images
  arm group label: Intermittent theta burst stimulation to right dorsolateral prefrontal cortex
  arm group type: Experimental
  description: Participants will receive intermittent theta burst stimulation (iTBS) to the experimental target area, the right dorsolateral prefrontal cortex (rDLPFC)
  arm group label: Intermittent theta burst stimulation to vertex of the skull
  arm group type: Active Comparator
  description: Participants will receive intermittent theta burst stimulation (iTBS) to the active comparator area, the vertex of the skull
  intervention type: Procedure
  intervention name: Transcranial Magnetic Stimulation (TMS)
  description: Participants will receive intermittent theta burst stimulation (iTBS) to two brain areas, the right dorsolateral prefrontal cortex (rDLPFC) and the vertex.
  arm group label: Intermittent theta burst stimulation to right dorsolateral prefrontal cortex
  arm group label: Intermittent theta burst stimulation to vertex of the skull
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Norman B Schmidt, PhD
  role: Principal Investigator
  affiliation: Distinguished Research Professor
  last name: Norman B Schmidt, PhD
  phone: (850) 645-1766
  email: abhcfsu@psy.fsu.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Florida State University
  investigator full name: Carter Bedford
  investigator title: Principal Investigator
  mesh term: Stress Disorders, Post-Traumatic