<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/NCT02192112</url>
  </required_header>
  <id_info>
    <org_study_id>NUVA.NV1301</org_study_id>
    <nct_id>NCT02192112</nct_id>
  </id_info>
  <brief_title>Advanced XLIF Monitoring Pilot Study</brief_title>
  <official_title>Evaluation of Transcutaneous Stimulation of Lumbosacral Nerve Roots: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NuVasive</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NuVasive</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Though the utility of NVM5 neuromonitoring by stimulating within the surgical site during&#xD;
      XLIF has been demonstrated, it is hypothesized that more information may be gathered if a&#xD;
      greater section of the motor neural pathway was monitored (i.e., stimulation above the&#xD;
      surgical site and recording the subsequent muscle response in the lower limbs). Currently,&#xD;
      there has not been demonstrated a practical method of stimulating the lumbosacral nerve roots&#xD;
      locally, but well-above the surgical site in this fashion.&#xD;
&#xD;
      This protocol is intended to evaluate the feasibility and reproducibility of using surface&#xD;
      stimulation and return (anode) electrodes to stimulate the lumbosacral nerve roots, and&#xD;
      record responses from the relevant innervated muscle groups of the lower limbs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">May 8, 2018</completion_date>
  <primary_completion_date type="Actual">May 8, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery.</measure>
    <time_frame>Intraoperative</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of any observed changes in the response or response thresholds with surgical events.</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between patient characteristics and the ability to generate and reliably record responses and response thresholds.</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between observed changes in the response or response threshold and postoperative neural status.</measure>
    <time_frame>6 weeks postoperative</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">57</enrollment>
  <condition>Degenerative Lumbar Disc Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        At least 20 subjects will be consecutively enrolled in this prospective pilot study from up&#xD;
        to three (3) participating centers. Patients who, in the surgeon investigator's opinion,&#xD;
        require lateral approach spinal fusion surgery at spinal level L4-5 (though may include any&#xD;
        number of levels from L2 through L5), and have consented to XLIF surgery for their&#xD;
        condition will be included. The following eligibility criteria are designed to identify&#xD;
        existing clinic patients for whom study under this protocol is considered appropriate. All&#xD;
        subjects must meet the inclusion/exclusion criteria below in order to be considered for&#xD;
        enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female spine surgery patients who are at least 18 years of age&#xD;
&#xD;
          2. Surgical candidates for lateral approach lumbar spine surgery at spinal levels L2 to&#xD;
             L5, inclusive of L4-5&#xD;
&#xD;
          3. Patients who understand the conditions of enrollment and are willing to sign an&#xD;
             informed consent to participate in the evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently undergoing surgical treatment at any spinal level other than L2 to L5,&#xD;
             including S1&#xD;
&#xD;
          2. Pregnant women&#xD;
&#xD;
          3. Implanted pacemaker, defibrillator, or other electronic devices&#xD;
&#xD;
          4. Involved in active litigation relating to the spine (worker's compensation claim is&#xD;
             allowed if it is not contested)&#xD;
&#xD;
          5. Underlying neurological disease or neurological deficit that is not associated with&#xD;
             the condition for which he/she is seeking surgical intervention (e.g., diabetic&#xD;
             peripheral neuropathy)&#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>Kyle Malone, MS</last_name>
    <role>Study Director</role>
    <affiliation>NuVasive</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Durango Orthopaedics Associates/Spine Colorado</name>
      <address>
        <city>Durango</city>
        <state>Colorado</state>
        <zip>81301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinnacle Orthopaedics &amp; Sports Medicine Specialists</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.nuvasive.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>August 24, 2018</last_update_submitted>
  <last_update_submitted_qc>August 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02192112
org study id: NUVA.NV1301
nct id: NCT02192112
lead sponsor: 
has dmc: No
Though the utility of NVM5 neuromonitoring by stimulating within the surgical site during
      XLIF has been demonstrated, it is hypothesized that more information may be gathered if a
      greater section of the motor neural pathway was monitored (i.e., stimulation above the
      surgical site and recording the subsequent muscle response in the lower limbs). Currently,
      there has not been demonstrated a practical method of stimulating the lumbosacral nerve roots
      locally, but well-above the surgical site in this fashion.

      This protocol is intended to evaluate the feasibility and reproducibility of using surface
      stimulation and return (anode) electrodes to stimulate the lumbosacral nerve roots, and
      record responses from the relevant innervated muscle groups of the lower limbs.
observational model: Cohort
time perspective: Prospective
measure: Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery.
time frame: Intraoperative
measure: Correlation of any observed changes in the response or response thresholds with surgical events.
time frame: Intraoperative
measure: Correlation between patient characteristics and the ability to generate and reliably record responses and response thresholds.
time frame: Intraoperative
measure: Correlation between observed changes in the response or response threshold and postoperative neural status.
time frame: 6 weeks postoperative
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kyle Malone, MS
role: Study Director
affiliation: NuVasive
facility: 
facility: 
country: United States
url: http://www.nuvasive.com
description: Related Info
responsible party type: Sponsor