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/NCT06000592</url>
    </required_header>
    <id_info>
      <org_study_id>1648740</org_study_id>
      <nct_id>NCT06000592</nct_id>
    </id_info>
    <brief_title>Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI</brief_title>
    <official_title>Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jill M. Wecht, Ed.D.</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Icahn School of Medicine at Mount Sinai</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>James J. Peters Veterans Affairs Medical Center</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>
        This site-specific project will focus on a novel non-pharmacologic approach to stabilizing BP&#xD;
        during AIR after acute traumatic SCI. Current forms of pharmacologic and non-pharmacologic&#xD;
        treatments for hypotension and OH remain inadequate in the SCI population. A critical need&#xD;
        exists for the identification of safe, practical and effective treatment options that&#xD;
        stabilize BP after traumatic SCI. Transcutaneous Spinal Cord Stimulation (TSCS) has several&#xD;
        advantages: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly,&#xD;
        and (3) can be applied in synergy with physical exercise. TSCS represents an alternate&#xD;
        approach to epidural SCS, with far greater potential to reach large numbers of individuals,&#xD;
        thus providing for a greater likelihood of clinical implementation with far fewer risks. We&#xD;
        are asking the key question: what if applying SCS earlier after injury could prevent the&#xD;
        development of BP instability? To facilitate adoption of TSCS for widespread clinical use, we&#xD;
        have designed a spatial-temporal mapping and parameter configuration approach that will&#xD;
        result in a key deliverable for SCI care: a standard, easy to follow algorithm that will&#xD;
        maximize individual benefits of spinal neuromodulation, while minimizing the burden on&#xD;
        healthcare professionals. This project will provide the foundational evidence to support the&#xD;
        feasible and safe application of TSCS for widespread clinical utility in the newly injured&#xD;
        population, thereby overcoming barriers to engagement in prescribed AIR regimens that are&#xD;
        imposed by ANS dysfunction.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Anticipated">October 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2026</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>
      <masking_description>Participant awareness during TSCS appears to be unavoidable. The FDA recognizes that some trials of non-pharmacological interventions cannot be fully shammed or blinded, yet with careful blinding of data assessors, it is possible to obtain reliable results that meet FDA approval criteria.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The safety (#1) of TSCS to improve autonomic control following acute SCI.</measure>
      <time_frame>Acute Inpatient Rehabilitation following SCI (up to 4 months)</time_frame>
      <description>Assess pain levels using a Likert Scale 0-10 (0=no pain, 10=worst pain).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The safety (#2) of TSCS to improve autonomic control following acute SCI.</measure>
      <time_frame>Acute Inpatient Rehabilitation following SCI (up to 4 months)</time_frame>
      <description>Document any skin changes (burns) following use of TSCS in count of occurrences.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The efficacy (#1) of TSCS to improve autonomic control following acute SCI.</measure>
      <time_frame>Acute Inpatient Rehabilitation following SCI (up to 4 months)</time_frame>
      <description>Blood pressure changes (mmHg) during the sit-up test with TSCS compared to no stimulation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The efficacy (#2) of TSCS to improve autonomic control following acute SCI.</measure>
      <time_frame>Acute Inpatient Rehabilitation following SCI (up to 4 months)</time_frame>
      <description>To compare dizziness symptoms on a Likert Scale 0-10 (0=no dizziness, 10=worst dizziness) during the sit-up test with TSCS compared to no stimulation..</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Acute Spinal Cord Injury</condition>
    <condition>Spinal Cord Injuries</condition>
    <condition>Neuromodulation</condition>
    <condition>Traumatic Spinal Cord Injury</condition>
    <condition>Spinal Cord Stimulation</condition>
    <condition>SCI - Spinal Cord Injury</condition>
    <condition>Blood Pressure</condition>
    <condition>Blood Pressure Disorders</condition>
    <arm_group>
      <arm_group_label>transcutaneous spinal stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Digitimer</intervention_name>
      <description>transcutaneous spinal cord stimulation for blood pressure control following spinal cord injury.</description>
      <arm_group_label>transcutaneous spinal stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Newly injured patients with traumatic SCI&#xD;
  &#xD;
            -  Admitted to Acute Inpatient Rehabilitation at Mount Sinai&#xD;
  &#xD;
            -  Within one year of SCI&#xD;
  &#xD;
            -  Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females)&#xD;
  &#xD;
            -  Orthostatic hypotension (fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥&#xD;
               10 mmHg within 10 minutes of assuming an upright position)&#xD;
  &#xD;
            -  Daily fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10&#xD;
               mmHg&#xD;
  &#xD;
            -  At least 14 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Implanted brain/spine/nerve stimulators&#xD;
  &#xD;
            -  Cochlear implants&#xD;
  &#xD;
            -  Cardiac pacemaker/defibrillator, or intracardiac lines&#xD;
  &#xD;
            -  Open skin lesions on or near the electrode placement sites (neck, upper back)&#xD;
  &#xD;
            -  Significant coronary artery or cardiac conduction disease&#xD;
  &#xD;
            -  Recent history of myocardial infarction&#xD;
  &#xD;
            -  Insufficient mental capacity to understand and independently provide consent&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Cancer&#xD;
  &#xD;
            -  Deemed unsuitable by study physician&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>The Icahn School of Medicine at Mount Sinai</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10029</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Miguel Escalón, MD, MPH</last_name>
        <phone>212-241-6321</phone>
        <email>miguel.escalon@mountsinai.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>James J. Peters Veterans Affairs Medical Center</investigator_affiliation>
      <investigator_full_name>Jill M. Wecht, Ed.D.</investigator_full_name>
      <investigator_title>Research Health Scientist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</mesh_term>
      <mesh_term>Wounds and Injuries</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/NCT06000592
  org study id: 1648740
  nct id: NCT06000592
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  This site-specific project will focus on a novel non-pharmacologic approach to stabilizing BP
        during AIR after acute traumatic SCI. Current forms of pharmacologic and non-pharmacologic
        treatments for hypotension and OH remain inadequate in the SCI population. A critical need
        exists for the identification of safe, practical and effective treatment options that
        stabilize BP after traumatic SCI. Transcutaneous Spinal Cord Stimulation (TSCS) has several
        advantages: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly,
        and (3) can be applied in synergy with physical exercise. TSCS represents an alternate
        approach to epidural SCS, with far greater potential to reach large numbers of individuals,
        thus providing for a greater likelihood of clinical implementation with far fewer risks. We
        are asking the key question: what if applying SCS earlier after injury could prevent the
        development of BP instability? To facilitate adoption of TSCS for widespread clinical use, we
        have designed a spatial-temporal mapping and parameter configuration approach that will
        result in a key deliverable for SCI care: a standard, easy to follow algorithm that will
        maximize individual benefits of spinal neuromodulation, while minimizing the burden on
        healthcare professionals. This project will provide the foundational evidence to support the
        feasible and safe application of TSCS for widespread clinical utility in the newly injured
        population, thereby overcoming barriers to engagement in prescribed AIR regimens that are
        imposed by ANS dysfunction.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Participant awareness during TSCS appears to be unavoidable. The FDA recognizes that some trials of non-pharmacological interventions cannot be fully shammed or blinded, yet with careful blinding of data assessors, it is possible to obtain reliable results that meet FDA approval criteria.
  measure: The safety (#1) of TSCS to improve autonomic control following acute SCI.
  time frame: Acute Inpatient Rehabilitation following SCI (up to 4 months)
  description: Assess pain levels using a Likert Scale 0-10 (0=no pain, 10=worst pain).
  measure: The safety (#2) of TSCS to improve autonomic control following acute SCI.
  time frame: Acute Inpatient Rehabilitation following SCI (up to 4 months)
  description: Document any skin changes (burns) following use of TSCS in count of occurrences.
  measure: The efficacy (#1) of TSCS to improve autonomic control following acute SCI.
  time frame: Acute Inpatient Rehabilitation following SCI (up to 4 months)
  description: Blood pressure changes (mmHg) during the sit-up test with TSCS compared to no stimulation.
  measure: The efficacy (#2) of TSCS to improve autonomic control following acute SCI.
  time frame: Acute Inpatient Rehabilitation following SCI (up to 4 months)
  description: To compare dizziness symptoms on a Likert Scale 0-10 (0=no dizziness, 10=worst dizziness) during the sit-up test with TSCS compared to no stimulation..
  arm group label: transcutaneous spinal stimulation
  arm group type: Experimental
  intervention type: Device
  intervention name: Digitimer
  description: transcutaneous spinal cord stimulation for blood pressure control following spinal cord injury.
  arm group label: transcutaneous spinal stimulation
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 100 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: James J. Peters Veterans Affairs Medical Center
  investigator full name: Jill M. Wecht, Ed.D.
  investigator title: Research Health Scientist
  mesh term: Spinal Cord Injuries
  mesh term: Wounds and Injuries