<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/NCT04457492</url>
  </required_header>
  <id_info>
    <org_study_id>19-5743</org_study_id>
    <nct_id>NCT04457492</nct_id>
  </id_info>
  <brief_title>Functional Electrical Stimulation for Facial Muscles</brief_title>
  <official_title>Applying Functional Electrical Stimulation to Facial Muscles After Acute Paralysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Partial or complete facial paralysis is the weakness of muscles of facial expression. Facial&#xD;
      paralysis causes physical, social and emotional problems. Functional electrical stimulation&#xD;
      (FES) for facial paralysis is a technique in which muscles are electrically stimulated,&#xD;
      causing them to contract This study is designed to help patients with facial nerve weakness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2021</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Lagophthalmos Over 14 weeks</measure>
    <time_frame>Measured at week 0, 7 and 14</time_frame>
    <description>Change in ability to close eyelids, measured in mm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Elevation of Corner of Mouth Over 14 weeks</measure>
    <time_frame>Measured at week 0, 7 and 14</time_frame>
    <description>Change in ability to raise corner of mouth, measured in mm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change House-Brackmann Scale Measurement Over 14 weeks</measure>
    <time_frame>Measured at week 0, 7 and 14</time_frame>
    <description>The House-Brackmann facial nerve grading scale is a measure of facial nerve impairment. The scale ranges from values 1 to 6, with larger values indicating greater facial nerve impairment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FaCE Questionnaire</measure>
    <time_frame>Administered at week 0, 7 and 14</time_frame>
    <description>Patient-based instrument to measure both facial impairment and disability. This will be used to identify patient's perceived change in facial impairment for the duration of the study period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Facial Movements Over 14 weeks</measure>
    <time_frame>Measured at week 0, 7 and 14</time_frame>
    <description>A video will be taken of the patient undergoing standard facial movements</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Study Interview</measure>
    <time_frame>Administered at week 0, 7 and 14</time_frame>
    <description>A structured interview questionnaire administered by a study team member to identify any changes to the therapy that may be needed before further studies are conducted</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Facial Nerve Paresis</condition>
  <arm_group>
    <arm_group_label>Acute Facial Nerve Injury with Intact Facial Nerve</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 sessions of FES (in a 14 week period)&#xD;
Assessments will be taken during the beginning, middle, and end of each study arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Facial Nerve Grafting After Surgical Excision</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 sessions of FES (in a 14 week period)&#xD;
Assessments will be taken during the beginning, middle, and end of each study arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No FES&#xD;
Assessments will be taken at the same intervals as the interventions group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Application of FES to the Face</intervention_name>
    <description>Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated.</description>
    <arm_group_label>Acute Facial Nerve Injury with Intact Facial Nerve</arm_group_label>
    <arm_group_label>Facial Nerve Grafting After Surgical Excision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients experiencing unilateral facial nerve paralysis Brackmann 5/6 or 6/6.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of epilepsy or seizures.&#xD;
&#xD;
          -  Individuals with metal orthopedic implants in the mouth (e.g. plates or screws).&#xD;
&#xD;
          -  Individuals suffering from fibromyalgia.&#xD;
&#xD;
          -  Individuals currently receiving any form of transcranial brain stimulation (e.g. rTMS,&#xD;
             ECT, or MST).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas Chepeha, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alex Esemezie, BACYC</last_name>
    <phone>416-340-3082</phone>
    <email>Alex.Esemezie@uhn.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alex Esemezie, BACYC</last_name>
      <phone>416-340-3082</phone>
      <email>alex.esemezie@uhn.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Facial Nerve Paralysis</keyword>
  <keyword>Functional Electrical Stimulation</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paresis</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/NCT04457492
org study id: 19-5743
nct id: NCT04457492
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Partial or complete facial paralysis is the weakness of muscles of facial expression. Facial
      paralysis causes physical, social and emotional problems. Functional electrical stimulation
      (FES) for facial paralysis is a technique in which muscles are electrically stimulated,
      causing them to contract This study is designed to help patients with facial nerve weakness.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Lagophthalmos Over 14 weeks
time frame: Measured at week 0, 7 and 14
description: Change in ability to close eyelids, measured in mm
measure: Change in Elevation of Corner of Mouth Over 14 weeks
time frame: Measured at week 0, 7 and 14
description: Change in ability to raise corner of mouth, measured in mm
measure: Change House-Brackmann Scale Measurement Over 14 weeks
time frame: Measured at week 0, 7 and 14
description: The House-Brackmann facial nerve grading scale is a measure of facial nerve impairment. The scale ranges from values 1 to 6, with larger values indicating greater facial nerve impairment.
measure: FaCE Questionnaire
time frame: Administered at week 0, 7 and 14
description: Patient-based instrument to measure both facial impairment and disability. This will be used to identify patient's perceived change in facial impairment for the duration of the study period.
measure: Change in Facial Movements Over 14 weeks
time frame: Measured at week 0, 7 and 14
description: A video will be taken of the patient undergoing standard facial movements
measure: Study Interview
time frame: Administered at week 0, 7 and 14
description: A structured interview questionnaire administered by a study team member to identify any changes to the therapy that may be needed before further studies are conducted
arm group label: Acute Facial Nerve Injury with Intact Facial Nerve
arm group type: Experimental
description: 40 sessions of FES (in a 14 week period)
Assessments will be taken during the beginning, middle, and end of each study arm.
arm group label: Facial Nerve Grafting After Surgical Excision
arm group type: Experimental
description: 40 sessions of FES (in a 14 week period)
Assessments will be taken during the beginning, middle, and end of each study arm.
arm group label: Standard of Care Group
arm group type: No Intervention
description: No FES
Assessments will be taken at the same intervals as the interventions group.
intervention type: Other
intervention name: Application of FES to the Face
description: Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated.
arm group label: Acute Facial Nerve Injury with Intact Facial Nerve
arm group label: Facial Nerve Grafting After Surgical Excision
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Douglas Chepeha, MD
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Alex Esemezie, BACYC
phone: 416-340-3082
email: Alex.Esemezie@uhn.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Paresis
mesh term: Facies