<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/NCT01726725</url>
  </required_header>
  <id_info>
    <org_study_id>B2012:099</org_study_id>
    <nct_id>NCT01726725</nct_id>
  </id_info>
  <brief_title>Hemifacial Spasm and Desflurane</brief_title>
  <acronym>HFS</acronym>
  <official_title>Investigating the Etiology of Hemifacial Spasm (HFS): The Role of Desflurane</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients are chosen to participate in this study because they will undergo a particular type&#xD;
      of brain surgery to treat their hemifacial spasm. This surgery is called microvascular&#xD;
      decompression (MVD) and involves the facial nerve. The facial nerve is being compressed by&#xD;
      one or more blood vessels and this contact produces the facial twitches. The investigators do&#xD;
      not know why a blood vessel that touches the facial nerve produces facial twitches. The&#xD;
      investigators are interested in investigating this during your surgery. A total of 25&#xD;
      participants are expected to participate in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      &quot;Intra Operative Monitoring&quot; (IOM) is a standard and routine medical practice for patients&#xD;
      having MVD surgery. IOM is done to make sure that the hearing and face nerves are not&#xD;
      accidentally bumped or damaged during surgery. After anesthetic induction, the&#xD;
      neurophysiologist places electrodes for the nerves, on the scalp and muscles. Stimulation and&#xD;
      monitoring of muscle twitches are all common, safe and painless medical procedures.&#xD;
&#xD;
      In this study, the investigators would like to measure the nerve and muscle function on the&#xD;
      normal side and compare it to nerve and muscle function on the abnormal side during different&#xD;
      levels of the anesthetic desflurane. In order to monitor the normal side of the face one&#xD;
      additional set of electrodes will be placed in the facial muscles. The investigators will&#xD;
      compare responses to three different levels of anesthetic. The technique used will be motor&#xD;
      evoked potentials. The effect of the anesthesia on the lateral spread response will also be&#xD;
      examined. This response is evident only on the symptomatic side. These observations will take&#xD;
      approximately 10 to 15 minutes and will not delay or lengthen the surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure EMG responses to peripheral nerve stimulation and motor cortex stimulation during changes in desflurane levels</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Hemifacial Spasm</condition>
  <arm_group>
    <arm_group_label>hemifacial spasm, lateral spread, motor evoked potentials</arm_group_label>
    <description>EMG recordings from facial muscles of HFS patients during MVD surgery will be compared during total intravenous anesthesia (propofol), 0.5 MAC desflurane and 1.0 MAC desflurane</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>desflurane</intervention_name>
    <arm_group_label>hemifacial spasm, lateral spread, motor evoked potentials</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with hemifacial spasm who will be undergoing microvascular decompression&#xD;
        surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients referred to the neurosurgical service for microvascular decompression surgery&#xD;
             for HFS&#xD;
&#xD;
          -  males and females 18 to 75 years of age&#xD;
&#xD;
          -  otherwise normal neurological exam&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Botox treatment within the last three months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marshall Wilkinson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>November 15, 2012</last_update_submitted>
  <last_update_submitted_qc>November 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hemifacial spasm</keyword>
  <keyword>microvascular decompression surgery</keyword>
  <keyword>desflurane</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Cramp</mesh_term>
    <mesh_term>Hemifacial Spasm</mesh_term>
    <mesh_term>Spasm</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Desflurane</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>December 1, 2014</submitted>
    <returned>December 4, 2014</returned>
    <submitted>May 27, 2015</submitted>
    <returned>June 10, 2015</returned>
    <submitted>September 12, 2019</submitted>
    <returned>October 2, 2019</returned>
  </pending_results>
  <!-- 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/NCT01726725
org study id: B2012:099
nct id: NCT01726725
lead sponsor: 
has dmc: Yes
Patients are chosen to participate in this study because they will undergo a particular type
      of brain surgery to treat their hemifacial spasm. This surgery is called microvascular
      decompression (MVD) and involves the facial nerve. The facial nerve is being compressed by
      one or more blood vessels and this contact produces the facial twitches. The investigators do
      not know why a blood vessel that touches the facial nerve produces facial twitches. The
      investigators are interested in investigating this during your surgery. A total of 25
      participants are expected to participate in this study.
"Intra Operative Monitoring" (IOM) is a standard and routine medical practice for patients
      having MVD surgery. IOM is done to make sure that the hearing and face nerves are not
      accidentally bumped or damaged during surgery. After anesthetic induction, the
      neurophysiologist places electrodes for the nerves, on the scalp and muscles. Stimulation and
      monitoring of muscle twitches are all common, safe and painless medical procedures.

      In this study, the investigators would like to measure the nerve and muscle function on the
      normal side and compare it to nerve and muscle function on the abnormal side during different
      levels of the anesthetic desflurane. In order to monitor the normal side of the face one
      additional set of electrodes will be placed in the facial muscles. The investigators will
      compare responses to three different levels of anesthetic. The technique used will be motor
      evoked potentials. The effect of the anesthesia on the lateral spread response will also be
      examined. This response is evident only on the symptomatic side. These observations will take
      approximately 10 to 15 minutes and will not delay or lengthen the surgery.
observational model: Case-Control
time perspective: Prospective
measure: Measure EMG responses to peripheral nerve stimulation and motor cortex stimulation during changes in desflurane levels
time frame: one year
arm group label: hemifacial spasm, lateral spread, motor evoked potentials
description: EMG recordings from facial muscles of HFS patients during MVD surgery will be compared during total intravenous anesthesia (propofol), 0.5 MAC desflurane and 1.0 MAC desflurane
intervention type: Drug
intervention name: desflurane
arm group label: hemifacial spasm, lateral spread, motor evoked potentials
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marshall Wilkinson, PhD
role: Principal Investigator
affiliation: University of Manitoba
responsible party type: Sponsor
mesh term: Muscle Cramp
mesh term: Hemifacial Spasm
mesh term: Spasm
mesh term: Desflurane
submitted: December 1, 2014
returned: December 4, 2014
submitted: May 27, 2015
returned: June 10, 2015
submitted: September 12, 2019
returned: October 2, 2019