<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/NCT03026816</url>
  </required_header>
  <id_info>
    <org_study_id>NEUROSURG-2017-25478</org_study_id>
    <nct_id>NCT03026816</nct_id>
  </id_info>
  <brief_title>Epidural Stimulation After Neurologic Damage</brief_title>
  <acronym>E-STAND</acronym>
  <official_title>Epidural Stimulation for Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Minnesota Office of Higher Education</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Minneapolis Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hennepin Healthcare Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hennepin County Medical Center, Minneapolis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate a method to optimize parameter settings in epidural spinal cord&#xD;
      stimulation used to recover lower extremity volitional movement. The study will also&#xD;
      characterize improvement in autonomic function (such as blood pressure control) and other&#xD;
      functions related to spinal cord injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epidural spinal cord stimulation for the purpose of facilitating volitional movement is a new&#xD;
      and novel neuromodulatory treatment. Epidural SCS has a long history of use for chronic pain&#xD;
      with established medical device platforms. The purpose of this study is to investigate and&#xD;
      establish the use of SCS for volitional movement. Specifically, establishing the&#xD;
      disinhibitory effect of SCS in a greater population with inherent greater variability.&#xD;
&#xD;
      In addition to establishing the disinhibitory effect of SCS for cSCI, our study attempts to&#xD;
      explore the parameter space of the spinal cord stimulator platforms in order to optimize&#xD;
      stimulation settings for patients through the creation of a clinical decision support system&#xD;
      (CDSS). Preliminary evidence suggests benefit to autonomic function, and this study also&#xD;
      begins to explore the effects of SCS on cardiovascular function, urinary function,&#xD;
      psychiatric outcomes, and quality of life, which all offer significant potential for patients&#xD;
      suffering from chronic spinal cord injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Anticipated">January 2028</completion_date>
  <primary_completion_date type="Anticipated">January 2027</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>
    <intervention_model_description>All subjects will receive study intervention. Outcome assessments will be tested while the stimulator unit is on (intervention) and off (sham) during the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Masking is done during formal testing of BMCA</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Volitional Response Index Magnitude</measure>
    <time_frame>Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15</time_frame>
    <description>Brain Motor Control Assessment Volitional Response Index Magnitude</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spinal cord stimulation for cardiovascular function</measure>
    <time_frame>Over 12 months</time_frame>
    <description>Systolic blood pressure measured during epidural stimulation (continuous)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebrovascular Assessment Change</measure>
    <time_frame>Months: 3, 6, 9</time_frame>
    <description>Cerebral blood flow (CBF) during tilt table</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visual Neurocognitive Assessment</measure>
    <time_frame>Months: 3, 6, 9</time_frame>
    <description>Stroop Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spinal cord stimulation optimization</measure>
    <time_frame>Over 12 months</time_frame>
    <description>Probit preference response surface obtained by serial force binary choice</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <condition>Paraplegia, Complete</condition>
  <arm_group>
    <arm_group_label>Epidural Spinal Cord Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Epidural Spinal Cord Stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Epidural Spinal Cord Stimulation</intervention_name>
    <description>epidural spinal cord stimulator</description>
    <arm_group_label>Epidural Spinal Cord Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  22 years of age or older&#xD;
&#xD;
          -  Able to undergo the informed consent/assent process&#xD;
&#xD;
          -  Stable, motor-complete paraplegia&#xD;
&#xD;
          -  Discrete spinal cord injury between C6 and T10&#xD;
&#xD;
          -  ASIA A or B Spinal Cord Injury Classification&#xD;
&#xD;
          -  Medically stable in the judgement of the principal investigator&#xD;
&#xD;
          -  Intact segmental reflexes below the lesion of injury&#xD;
&#xD;
          -  Greater than 1 year since initial injury and at least 6 months from any required&#xD;
             spinal instrumentation&#xD;
&#xD;
          -  Willing to attend all scheduled appointments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diseases and conditions that would increase the morbidity and mortality of spinal cord&#xD;
             injury surgery (e.g. cardiopulmonary issues)&#xD;
&#xD;
          -  Inability to withhold antiplatelet/anticoagulation agents perioperatively&#xD;
&#xD;
          -  Significant dysautonomia that would prohibit rehabilitation or assisted standing or&#xD;
             any history of CVA or MI associated with autonomic dysreflexia. A single tilt table&#xD;
             test with syncope, presyncope, or SBP &lt; 50 or &gt;200.&#xD;
&#xD;
          -  Other conditions that would make the subject unable to participate in&#xD;
             testing/rehabilitation in the judgement of the principal investigator&#xD;
&#xD;
          -  Current and anticipated need for opioid pain medications or pain that would prevent&#xD;
             full participation in the rehabilitation program in the judgement of the principal&#xD;
             investigator&#xD;
&#xD;
          -  Clinically significant mental illness in the judgement of the principal investigator&#xD;
&#xD;
          -  Botulinum toxin injections in the previous 6 months&#xD;
&#xD;
          -  Volitional movements present during EMG testing in bilateral lower extremities&#xD;
&#xD;
          -  Unhealed spinal fracture&#xD;
&#xD;
          -  Presence of significant contracture&#xD;
&#xD;
          -  Presence of pressure ulcers&#xD;
&#xD;
          -  Recurrent urinary tract infection refractory to antibiotics&#xD;
&#xD;
          -  Current Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Darrow, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Study Coordinator</last_name>
    <phone>612-873-9113</phone>
    <email>estand@umn.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>David Darrow, MD MPH</last_name>
    <phone>612-217-4290</phone>
    <email>estand@umn.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Darrow, MD MPH</last_name>
      <phone>612-217-4290</phone>
      <email>estand@umn.edu</email>
    </contact>
    <contact_backup>
      <last_name>Study Coordinator</last_name>
      <phone>612-873-9113</phone>
      <email>estand@umn.edu</email>
    </contact_backup>
    <investigator>
      <last_name>David Darrow, MD MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.estand.org</url>
    <description>Clinical Trial Website</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 1, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>epidural stimulation</keyword>
  <keyword>spinal cord stimulation</keyword>
  <keyword>autonomic dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Paraplegia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03026816
org study id: NEUROSURG-2017-25478
nct id: NCT03026816
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This study will evaluate a method to optimize parameter settings in epidural spinal cord
      stimulation used to recover lower extremity volitional movement. The study will also
      characterize improvement in autonomic function (such as blood pressure control) and other
      functions related to spinal cord injury.
Epidural spinal cord stimulation for the purpose of facilitating volitional movement is a new
      and novel neuromodulatory treatment. Epidural SCS has a long history of use for chronic pain
      with established medical device platforms. The purpose of this study is to investigate and
      establish the use of SCS for volitional movement. Specifically, establishing the
      disinhibitory effect of SCS in a greater population with inherent greater variability.

      In addition to establishing the disinhibitory effect of SCS for cSCI, our study attempts to
      explore the parameter space of the spinal cord stimulator platforms in order to optimize
      stimulation settings for patients through the creation of a clinical decision support system
      (CDSS). Preliminary evidence suggests benefit to autonomic function, and this study also
      begins to explore the effects of SCS on cardiovascular function, urinary function,
      psychiatric outcomes, and quality of life, which all offer significant potential for patients
      suffering from chronic spinal cord injury.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All subjects will receive study intervention. Outcome assessments will be tested while the stimulator unit is on (intervention) and off (sham) during the study.
primary purpose: Treatment
masking: None (Open Label)
masking description: Masking is done during formal testing of BMCA
measure: Change in Volitional Response Index Magnitude
time frame: Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
description: Brain Motor Control Assessment Volitional Response Index Magnitude
measure: Spinal cord stimulation for cardiovascular function
time frame: Over 12 months
description: Systolic blood pressure measured during epidural stimulation (continuous)
measure: Cerebrovascular Assessment Change
time frame: Months: 3, 6, 9
description: Cerebral blood flow (CBF) during tilt table
measure: Change in Visual Neurocognitive Assessment
time frame: Months: 3, 6, 9
description: Stroop Test
measure: Spinal cord stimulation optimization
time frame: Over 12 months
description: Probit preference response surface obtained by serial force binary choice
arm group label: Epidural Spinal Cord Stimulation
arm group type: Experimental
description: Epidural Spinal Cord Stimulation
intervention type: Device
intervention name: Epidural Spinal Cord Stimulation
description: epidural spinal cord stimulator
arm group label: Epidural Spinal Cord Stimulation
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: David Darrow, MD
role: Principal Investigator
affiliation: University of Minnesota
last name: Study Coordinator
phone: 612-873-9113
email: estand@umn.edu
last name: David Darrow, MD MPH
phone: 612-217-4290
email: estand@umn.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: http://www.estand.org
description: Clinical Trial Website
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Paraplegia