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/NCT05989763</url>
    </required_header>
    <id_info>
      <org_study_id>HSC-MS-23-0531</org_study_id>
      <nct_id>NCT05989763</nct_id>
    </id_info>
    <brief_title>Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis</brief_title>
    <acronym>TEA in SSc</acronym>
    <official_title>Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>The University of Texas Health Science Center, Houston</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to determine whether transcutaneous electrical acustimulation&#xD;
        (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing&#xD;
        autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow&#xD;
        colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves&#xD;
        autonomic dysfunction and modulates inflammatory pathways.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2029</completion_date>
    <primary_completion_date type="Anticipated">August 14, 2028</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>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in slow colonic transit (SCT)</measure>
      <time_frame>baseline, week 4 (visit 2)</time_frame>
      <description>slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in rectal hyposensitivity as assessed by the anorectal manometry</measure>
      <time_frame>baseline, week 4 (visit 2)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures</measure>
      <time_frame>baseline, week 4 (visit 2)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in autonomic dysfunction as assessed by the COMPASS-31 measures</measure>
      <time_frame>baseline, week 4 (visit 2)</time_frame>
      <description>This is a 31 item questionnaire and scores range from 0-100 a higher score indicating more severe autonomic dysfunction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),</measure>
      <time_frame>baseline, week 4 (visit 2)</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Systemic Sclerosis</condition>
    <condition>Constipation</condition>
    <condition>Gastrointestinal Motility Disorder</condition>
    <condition>Autonomic Dysfunction</condition>
    <arm_group>
      <arm_group_label>Transcutaneous Electrical Acustimulation (TEA)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham-TEA</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcutaneous Electrical Acustimulation (TEA)</intervention_name>
      <description>TEA will then be administrated for 1 hour twice daily for a period of 4 weeks</description>
      <arm_group_label>Transcutaneous Electrical Acustimulation (TEA)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham-TEA</intervention_name>
      <description>Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks</description>
      <arm_group_label>Sham-TEA</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
            -  Patients with SSc-constipation from Aim 1 of the study&#xD;
  &#xD;
            -  Patients with SCT (&gt;20% radiopaque marks left in the colon 5 days (120 hours) after&#xD;
               swallowing the Sitzmark capsule or patients with RH (defined in Aim 1)&#xD;
  &#xD;
            -  Patients not yet on therapy for constipation or patients who continue to experience&#xD;
               constipation while on stable therapy for one month prior to TEA.&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
          -Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of&#xD;
          constipation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zsuzsanna H McMahan, MD, MHS (M-PI)</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas Health Science Center, Houston</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zsuzsanna H McMahan, MD, MHS (M-PI)</last_name>
      <phone>7135007531</phone>
      <email>Zsuzsanna.H.McMahan@uth.tmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sharvari R Kamat</last_name>
      <phone>713-500-6898</phone>
      <email>Sharvari.R.Kamat@uth.tmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Texas Health Science Center at Houston</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Zsuzsanna H McMahan, MD, MHS (M-PI)</last_name>
        <phone>713-500-6883</phone>
        <email>Zsuzsanna.H.McMahan@uth.tmc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Sharvari R Kamat</last_name>
        <phone>713-500-6898</phone>
        <email>Sharvari.R.Kamat@uth.tmc.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
      <investigator_full_name>Zsuzsanna Hortobagyi Mcmahan</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autonomic Nervous System Diseases</mesh_term>
      <mesh_term>Primary Dysautonomias</mesh_term>
      <mesh_term>Scleroderma, Systemic</mesh_term>
      <mesh_term>Scleroderma, Diffuse</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
      <mesh_term>Constipation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05989763
  org study id: HSC-MS-23-0531
  nct id: NCT05989763
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  The purpose of this study is to determine whether transcutaneous electrical acustimulation
        (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing
        autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow
        colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves
        autonomic dysfunction and modulates inflammatory pathways.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in slow colonic transit (SCT)
  time frame: baseline, week 4 (visit 2)
  description: slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion
  measure: Change in rectal hyposensitivity as assessed by the anorectal manometry
  time frame: baseline, week 4 (visit 2)
  measure: Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures
  time frame: baseline, week 4 (visit 2)
  measure: Change in autonomic dysfunction as assessed by the COMPASS-31 measures
  time frame: baseline, week 4 (visit 2)
  description: This is a 31 item questionnaire and scores range from 0-100 a higher score indicating more severe autonomic dysfunction
  measure: Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),
  time frame: baseline, week 4 (visit 2)
  arm group label: Transcutaneous Electrical Acustimulation (TEA)
  arm group type: Experimental
  arm group label: Sham-TEA
  arm group type: Sham Comparator
  intervention type: Device
  intervention name: Transcutaneous Electrical Acustimulation (TEA)
  description: TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
  arm group label: Transcutaneous Electrical Acustimulation (TEA)
  intervention type: Device
  intervention name: Sham-TEA
  description: Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
  arm group label: Sham-TEA
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Zsuzsanna H McMahan, MD, MHS (M-PI)
  role: Principal Investigator
  affiliation: The University of Texas Health Science Center, Houston
  last name: Zsuzsanna H McMahan, MD, MHS (M-PI)
  phone: 7135007531
  email: Zsuzsanna.H.McMahan@uth.tmc.edu
  last name: Sharvari R Kamat
  phone: 713-500-6898
  email: Sharvari.R.Kamat@uth.tmc.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center, Houston
  investigator full name: Zsuzsanna Hortobagyi Mcmahan
  investigator title: Associate Professor
  mesh term: Autonomic Nervous System Diseases
  mesh term: Primary Dysautonomias
  mesh term: Scleroderma, Systemic
  mesh term: Scleroderma, Diffuse
  mesh term: Sclerosis
  mesh term: Constipation
  sharing ipd: No