<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/NCT03006783</url>
  </required_header>
  <id_info>
    <org_study_id>TvanVeen</org_study_id>
    <nct_id>NCT03006783</nct_id>
  </id_info>
  <brief_title>Assessment of the Cross-face Nerve Graft in the Treatment of Facial Paralysis</brief_title>
  <official_title>Assessment of the Cross-face Nerve Graft in the Treatment of Facial Paralysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <brief_summary>
    <textblock>
      A retrospective and cross-sectional analysis of standard of care for facial paralysis&#xD;
      involving the cross-face nerve graft in the past 20 years.&#xD;
&#xD;
        -  Imagery analysis&#xD;
&#xD;
        -  Questionnaires&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will retrospectively and cross sectionally analyze all patients treated&#xD;
      with a cross-face nerve graft and another nerve transfer in our institution by image analysis&#xD;
      and sending out quality of life questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Symmetry of the mouth</measure>
    <time_frame>March 2016 - October 2016</time_frame>
    <description>Symmetry of the mouth expressed as the difference in millimeters between the position of the affected and the healthy corner of the mouth on a picture. An ideal symmetry would be 0 mm. Measured with the FACE-gram software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Excursion of the mouth</measure>
    <time_frame>March 2016 - October 2016</time_frame>
    <description>Excursion of the mouth expressed as the difference in millimeters between the position of the affected corner of the mouth in repose and with smile on a picture. Measured with the FACE-gram software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease-specific quality-of-life</measure>
    <time_frame>March 2016 - October 2016</time_frame>
    <description>A validated self-reported disease-specific quality-of-life questionnaire was used (Facial Clinimetric Evaluation scale). On which patients can score anything between 0 and 100 points (100 being healty).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Facial Palsy</condition>
  <arm_group>
    <arm_group_label>Cross-face nerve graft treated</arm_group_label>
    <description>People treated by a solitary cross-face nerve graft or in combination with another procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypoglossal-facial treated</arm_group_label>
    <description>People treated with a solitary hypoglossal-facial anastomosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cross-face nerve graft</intervention_name>
    <description>connecting the healthy facial nerve to the affected facial nerve</description>
    <arm_group_label>Cross-face nerve graft treated</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Retrospective cohort of people treated with a cross-face nerve graft or other nerve&#xD;
        transfer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Treated with one of the described procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evaluation material present&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 28, 2016</last_update_submitted>
  <last_update_submitted_qc>December 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Tijn van Veen</investigator_full_name>
    <investigator_title>M.M. van Veen, BSc</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bell Palsy</mesh_term>
    <mesh_term>Facial Paralysis</mesh_term>
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Facies</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/NCT03006783
org study id: TvanVeen
nct id: NCT03006783
lead sponsor: 
A retrospective and cross-sectional analysis of standard of care for facial paralysis
      involving the cross-face nerve graft in the past 20 years.

        -  Imagery analysis

        -  Questionnaires
The investigators will retrospectively and cross sectionally analyze all patients treated
      with a cross-face nerve graft and another nerve transfer in our institution by image analysis
      and sending out quality of life questionnaires.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Symmetry of the mouth
time frame: March 2016 - October 2016
description: Symmetry of the mouth expressed as the difference in millimeters between the position of the affected and the healthy corner of the mouth on a picture. An ideal symmetry would be 0 mm. Measured with the FACE-gram software.
measure: Excursion of the mouth
time frame: March 2016 - October 2016
description: Excursion of the mouth expressed as the difference in millimeters between the position of the affected corner of the mouth in repose and with smile on a picture. Measured with the FACE-gram software.
measure: Disease-specific quality-of-life
time frame: March 2016 - October 2016
description: A validated self-reported disease-specific quality-of-life questionnaire was used (Facial Clinimetric Evaluation scale). On which patients can score anything between 0 and 100 points (100 being healty).
arm group label: Cross-face nerve graft treated
description: People treated by a solitary cross-face nerve graft or in combination with another procedure.
arm group label: Hypoglossal-facial treated
description: People treated with a solitary hypoglossal-facial anastomosis.
intervention type: Procedure
intervention name: Cross-face nerve graft
description: connecting the healthy facial nerve to the affected facial nerve
arm group label: Cross-face nerve graft treated
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Tijn van Veen
investigator title: M.M. van Veen, BSc
mesh term: Bell Palsy
mesh term: Facial Paralysis
mesh term: Paralysis
mesh term: Facies