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/NCT06016764</url>
    </required_header>
    <id_info>
      <org_study_id>220645</org_study_id>
      <nct_id>NCT06016764</nct_id>
    </id_info>
    <brief_title>Use of MRI and cTBS for Catatonia in Autism</brief_title>
    <official_title>Use of Magnetic Resonance Imaging and Continuous Theta Burst Stimulation for Catatonia in Autism</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vanderbilt University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Vanderbilt Kennedy Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Vanderbilt University Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Despite the significant morbidity and mortality associated with catatonia in autism, no&#xD;
        diagnostic research has attempted to identify biomarkers for catatonia. This application will&#xD;
        use a participant's own individual brain magnetic resonance image to target the primary motor&#xD;
        strip with transcranial magnetic stimulation; to determine if hyper-excitability of the brain&#xD;
        directly correlates with symptoms of catatonia and social-emotional impairment in autism.&#xD;
        Completion of this project would result in the first study to associate hyper-excitability of&#xD;
        the brain with catatonia and core features of autism; findings which are likely to have a&#xD;
        significant impact on the health and well-being of autistic individuals.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 23, 2023</start_date>
    <completion_date type="Anticipated">August 23, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 23, 2025</primary_completion_date>
    <phase>Phase 1</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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The change in motor evoked potentials elicited from transcranial magnetic stimulation</measure>
      <time_frame>After cTBS, batches of 10 MEPs will be measured every 20 minutes for a total of 120 minutes to track ∆MEP amplitude over time.</time_frame>
      <description>Three batches of 10 MEPs will be recorded before cTBS and used as a baseline measure of motor evoked potentials.</description>
    </primary_outcome>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <condition>Catatonia</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Continuous Theta Burst in Transcranial Magnetic Stimulation</intervention_name>
      <description>This application will use a participant's own individual brain magnetic resonance image to target the primary motor strip with transcranial magnetic stimulation; to determine if hyper-excitability of the brain directly correlates with symptoms of catatonia and social-emotional impairment in autism</description>
      <other_name>cTBS</other_name>
      <other_name>TMS</other_name>
      <other_name>Neuromodulation</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Individuals aged 15-40 years of age will be enrolled. This age range was selected&#xD;
               given the high degree of social development occurring in this life stage, the&#xD;
               developmental nature of ASD, and ongoing cTBS-induced changes in MEP amplitude&#xD;
               observed in AIC individuals as they age.26,75-77&#xD;
  &#xD;
            -  Subjects and/or guardians must also be fluent in English, diagnosed with ASD based on&#xD;
               DSM-5 criteria1 and Autism Diagnostic Observation Schedule-II (ADOS-II) assessment,78&#xD;
               and competent to assent to the study based on investigator clinical evaluation.&#xD;
               Consenting guardians will be included if indicated.&#xD;
  &#xD;
            -  Subjects, or guardians if subjects cannot consent, must be competent to consent to the&#xD;
               study. Subjects must be able to assent to the study as determined by clinical&#xD;
               evaluation from the primary investigator.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of substance abuse/dependence,&#xD;
  &#xD;
            -  History of concomitant major medical/neurologic illness&#xD;
  &#xD;
            -  History of seizure within one calendar year&#xD;
  &#xD;
            -  History of traumatic brain injury&#xD;
  &#xD;
            -  Pregnant or currently breastfeeding&#xD;
  &#xD;
            -  Are psychiatrically or medically unstable as determined by the investigator clinical&#xD;
               evaluation&#xD;
  &#xD;
            -  Prescribed medication contraindicated in TMS&#xD;
  &#xD;
            -  Have a history of TMS treatment.&#xD;
  &#xD;
            -  Are diagnosed with a syndrome which results in ASD symptoms as preliminary research&#xD;
               suggests individuals with these diagnoses have differing biomarker responses to TMS.26&#xD;
  &#xD;
            -  Children below the age of fifteen will also be excluded because of decreased&#xD;
               likelihood of remaining still in the MRI scanner, as well as for scientific reasons&#xD;
               surrounding unknown variability for key variables during pubertal onset.&#xD;
  &#xD;
            -  MRI scanning also introduces exclusionary criteria for conditions contraindicated to&#xD;
               MRI, thus individuals with any bodily metal, history of claustrophobia, or pacemakers&#xD;
               will be excluded.&#xD;
  &#xD;
            -  Expresses dissenting behaviors as outlined below.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Joshua R Smith</last_name>
      <phone>6159363555</phone>
      <email>Joshua.R.Smith@vumc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sarah Mahler, MS</last_name>
      <phone>6159363555</phone>
      <email>sarah.marler@vumc.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Vanderbilt University Medical Center</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37212</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joshua R Smith, MD</last_name>
        <phone>615-936-3555</phone>
        <email>Joshua.R.Smith@vumc.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
      <investigator_full_name>Joshua Ryan Smith, MD</investigator_full_name>
      <investigator_title>Assistant Professor of Psychiatry and Behavioral Sciences</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Catatonia</mesh_term>
      <mesh_term>Autistic Disorder</mesh_term>
      <mesh_term>Autism Spectrum Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06016764
  org study id: 220645
  nct id: NCT06016764
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Despite the significant morbidity and mortality associated with catatonia in autism, no
        diagnostic research has attempted to identify biomarkers for catatonia. This application will
        use a participant's own individual brain magnetic resonance image to target the primary motor
        strip with transcranial magnetic stimulation; to determine if hyper-excitability of the brain
        directly correlates with symptoms of catatonia and social-emotional impairment in autism.
        Completion of this project would result in the first study to associate hyper-excitability of
        the brain with catatonia and core features of autism; findings which are likely to have a
        significant impact on the health and well-being of autistic individuals.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: The change in motor evoked potentials elicited from transcranial magnetic stimulation
  time frame: After cTBS, batches of 10 MEPs will be measured every 20 minutes for a total of 120 minutes to track ∆MEP amplitude over time.
  description: Three batches of 10 MEPs will be recorded before cTBS and used as a baseline measure of motor evoked potentials.
  intervention type: Device
  intervention name: Continuous Theta Burst in Transcranial Magnetic Stimulation
  description: This application will use a participant's own individual brain magnetic resonance image to target the primary motor strip with transcranial magnetic stimulation; to determine if hyper-excitability of the brain directly correlates with symptoms of catatonia and social-emotional impairment in autism
  other name: cTBS
  other name: TMS
  other name: Neuromodulation
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Joshua R Smith
  phone: 6159363555
  email: Joshua.R.Smith@vumc.org
  last name: Sarah Mahler, MS
  phone: 6159363555
  email: sarah.marler@vumc.org
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Vanderbilt University Medical Center
  investigator full name: Joshua Ryan Smith, MD
  investigator title: Assistant Professor of Psychiatry and Behavioral Sciences
  mesh term: Catatonia
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  sharing ipd: Undecided