<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/NCT02237599</url>
  </required_header>
  <id_info>
    <org_study_id>104826</org_study_id>
    <nct_id>NCT02237599</nct_id>
  </id_info>
  <brief_title>Somatosensory Evoked Potential Algorithm for Detection of Intraoperative Positional Neuropraxia</brief_title>
  <acronym>EPAD</acronym>
  <official_title>A Feasibility Study of Integrated SSEP and Detection Algorithm for Detection of Intraoperative Positional Neuropraxia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study hypothesizes that an automated device using small electronic impulses can detect&#xD;
      nerve impairment in unconscious patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Application of SSEP probes to bilateral ulnar and popliteal nerve areas with sensors at (1)&#xD;
      bilateral brachial plexus (clavicles), (2) Erb's point (posterior C8 cervical spine) and (3)&#xD;
      on forehead will permit microvolt current to to be detected and analyzed against a&#xD;
      proprietary algorithm. Neuropraxia will be detected based on abnormalities developing in&#xD;
      received SSEP signals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neuropraxia</measure>
    <time_frame>postoperative</time_frame>
    <description>Correlation between postoperative neuropraxia and intraoperative alert of impaired neural transmission detected via EPAD</description>
  </primary_outcome>
  <enrollment type="Actual">115</enrollment>
  <condition>Neuropraxia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Intraoperative adult patients undergoing surgical procedure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neuromuscular disease stroke&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John M Murkin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>March 4, 2019</last_update_submitted>
  <last_update_submitted_qc>March 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>John Murkin</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>SSEP</keyword>
  <keyword>neuropraxia</keyword>
  <keyword>intraoperative</keyword>
  <keyword>automated</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02237599
org study id: 104826
nct id: NCT02237599
lead sponsor: 
has dmc: No
This study hypothesizes that an automated device using small electronic impulses can detect
      nerve impairment in unconscious patients.
Application of SSEP probes to bilateral ulnar and popliteal nerve areas with sensors at (1)
      bilateral brachial plexus (clavicles), (2) Erb's point (posterior C8 cervical spine) and (3)
      on forehead will permit microvolt current to to be detected and analyzed against a
      proprietary algorithm. Neuropraxia will be detected based on abnormalities developing in
      received SSEP signals.
observational model: Case-Only
time perspective: Prospective
measure: Neuropraxia
time frame: postoperative
description: Correlation between postoperative neuropraxia and intraoperative alert of impaired neural transmission detected via EPAD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: John M Murkin, MD
role: Principal Investigator
affiliation: Western University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: John Murkin
investigator title: PI
sharing ipd: No