<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/NCT03836989</url>
  </required_header>
  <id_info>
    <org_study_id>16901</org_study_id>
    <nct_id>NCT03836989</nct_id>
  </id_info>
  <brief_title>Electrical Stimulation to Promote Recovery in Bells Palsy</brief_title>
  <official_title>Pilot Clinical Trial to Study Facial Electrical Stimulation to Promote Recovery in Patients With Bell's Palsy and Poor Prognostic Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A feasibility pilot study to exam the necessary methodology for conducting a larger clinical&#xD;
      trial for Bell's Palsy patients with a poor prognosis and the use of electrical stimulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Here we describe a protocol for a prospective, randomized, double-blinded study to evaluate&#xD;
      the effects of monophasic pulsed current ES on patients with Bell's palsy and factors&#xD;
      predicting poor recovery, with a 6 month follow up. Motor level stimulation with a pulse&#xD;
      duration of 100 μsec and a frequency of 35 pulses per second were chosen from focus group&#xD;
      with physical therapist to treat facial paralysis and are consistent with clinical trials&#xD;
      showing motor benefit after capel tunnel surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">January 22, 2018</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 21, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigator and outcome assessors are blinded to the intervention. The physical therapist that teaches the research subjects how to perform the interventions are not blinded and patients are told they are assigned to either sensory or subsensory protocols.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions</measure>
    <time_frame>3 months</time_frame>
    <description>To evaluate for complete recovery, standardized photos of patients at rest, and during movement, will be evaluated by three treatment-blinded otolaryngologists. Total number of patients fully recovered over number of participants will be reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>House Brackmann Scale</measure>
    <time_frame>Baseline, and 3 months</time_frame>
    <description>Determined by three blinded otolaryngologist reviewing facial photos of patients with smile and eye closure. Reported as an average of the three scores. The scales ranges from 1 (normal) to 6 (most severe dysfunction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ)</measure>
    <time_frame>Baseline, 3 months and 6 months</time_frame>
    <description>Quality of life is in part measured in this study using the patient reported Synkinesis Assessment Questionnaire (SAQ). The instrument consisting of 10 items asks participants how difficult certain facial activities are. Based on the average score for each domain the test gives a score between 20 (no synkinesis) to 100 (severe synkinesis, all the time).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Global Quality of Life Specific to Facial Paralysis</measure>
    <time_frame>Baseline, 3 months and 6 months</time_frame>
    <description>Measured by the validated quality of life patient reported questionnaire Facial Clinimetric Evaluation (FaCE) Scale with a scale from 0 (normal) to 100 (severe dysfunction). The scale encompasses facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Measurements of Brow Elevation</measure>
    <time_frame>Baseline and in 3 months</time_frame>
    <description>Measuring brow elevation using the MEEI FACE-gram program reported as the millimeters in decreased elevation in comparison to the unaffected side</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eye Closure</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Measuring in millimeters of the eyelids remaining open during maximal eye closure using the MEEI FACE-gram program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smile Excursion</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Measuring oral commissure exclusion using the MEEI FACE-gram program reported as the change in millimeters in the distance between the midline of the lower lip and the oral commissure in comparison between rest and smile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Facial Symmetry at Rest</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Measured by facial asymmetry index (FAI) at rest in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals no difference between sides and perfect symmetry. The closer a number is to 0, the higher the symmetry is. Ranges have not been published for this scale. FAI does not have a maximum score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Facial Symmetry During Smile</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Measured by facial asymmetry index (FAI) during smile in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals perfect symmetry and no difference in sides. The closer a number is to 0, the greater the symmetry. Ranges have not been published for this scale. FAI does not have a maximum score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Tolerability</measure>
    <time_frame>3 months</time_frame>
    <description>Measured by a visual analog scale (VAS) which ranged from 0 to 10 where 0 stands for completely comfortable and 10 to very uncomfortable. A questionnaire designed by research team using a Likert's scale was created to measure patient tolerability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Reported Subject Adherence</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of subjected who reported full adherence, partial adherence and non-adherence confirmed by comparing to the daily diary of use.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Bell Palsy</condition>
  <arm_group>
    <arm_group_label>High-volt electrical stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.&#xD;
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.&#xD;
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subsensory electrical stimulation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrical stimulation device (tens unit)</intervention_name>
    <description>An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory</description>
    <arm_group_label>High-volt electrical stimulation</arm_group_label>
    <arm_group_label>Subsensory electrical stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New diagnosis of bell's palsy (diagnosed in the last 30 days)&#xD;
&#xD;
          -  IF younger than 60 years of age must have complete paralysis on one side of face or&#xD;
             both&#xD;
&#xD;
          -  IF older than 60 years of age paralysis must be present but CAN be incomplete.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Paralysis associated with any of the fallowing: cancer, tumor, surgery, stroke, or&#xD;
             trauma.&#xD;
&#xD;
          -  Younger than 60 years old with INCOMPLETE paralysis.&#xD;
&#xD;
          -  Non English speakers&#xD;
&#xD;
          -  Pacemaker or deep brain stimulator&#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>Myriam D Loyo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <results_first_submitted>January 15, 2021</results_first_submitted>
  <results_first_submitted_qc>May 7, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 11, 2021</results_first_posted>
  <last_update_submitted>May 7, 2021</last_update_submitted>
  <last_update_submitted_qc>May 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Myriam Loyo</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Facial Paralysis</keyword>
  <keyword>Bell Palsy</keyword>
  <keyword>Electrical Stimulation</keyword>
  <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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03836989/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Blocks were designed to account for predictors of recovery. There were four allocation blocks: 1) &gt;60 age with complete paralysis, 2) &gt; 60 age with incomplete paralysis, 3) &lt;60 age with complete paralysis and &lt; 15 days duration, or 4) &lt;60 age with complete paralysis and &gt;15 days duration.&#xD;
The block size was 2 and the allocation was 1:1. All patients were randomly allocated to high-volt arm</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>High-volt Electrical Stimulation</title>
          <description>Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.&#xD;
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.&#xD;
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved.</description>
        </group>
        <group group_id="P2">
          <title>Subsensory Electrical Stimulation</title>
          <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subjects &gt; 60 Years Old With Complete Paralysis</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subjects &gt; 60 Years Old With Incomplete Paralysis</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subject &lt; 60 Years Old + Complete Paralysis &lt; 15 Days Duration</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subjects &lt; 60 Years Old + Complete Paralysis &gt; 15 Days</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomization led to no participants in the Subsensory arm.</population>
      <group_list>
        <group group_id="B1">
          <title>High-volt Electrical Stimulation</title>
          <description>Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.&#xD;
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.&#xD;
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved</description>
        </group>
        <group group_id="B2">
          <title>Subsensory Electrical Stimulation</title>
          <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions</title>
        <description>To evaluate for complete recovery, standardized photos of patients at rest, and during movement, will be evaluated by three treatment-blinded otolaryngologists. Total number of patients fully recovered over number of participants will be reported.</description>
        <time_frame>3 months</time_frame>
        <population>Randomization led to no Subsensory participants.</population>
        <group_list>
          <group group_id="O1">
            <title>High-volt Electrical Stimulation</title>
            <description>Plan to use a monophasic waveform having 100µmsec pulse duration, 35 Hz and using tolerated voltage for a total of 20 minutes. Electrical stimulation will be produced with the Orthostim 3 device. The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral arm.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Subsensory Electrical Stimulation</title>
            <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions</title>
          <description>To evaluate for complete recovery, standardized photos of patients at rest, and during movement, will be evaluated by three treatment-blinded otolaryngologists. Total number of patients fully recovered over number of participants will be reported.</description>
          <population>Randomization led to no Subsensory participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>House Brackmann Scale</title>
        <description>Determined by three blinded otolaryngologist reviewing facial photos of patients with smile and eye closure. Reported as an average of the three scores. The scales ranges from 1 (normal) to 6 (most severe dysfunction)</description>
        <time_frame>Baseline, and 3 months</time_frame>
        <population>No subjects underwent subsensory electrical stimulation</population>
        <group_list>
          <group group_id="O1">
            <title>High-volt Electrical Stimulation</title>
            <description>Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.&#xD;
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.&#xD;
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved.&#xD;
Electrical stimulation device (tens unit): An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory</description>
          </group>
          <group group_id="O2">
            <title>Subsensory Electrical Stimulation</title>
            <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.&#xD;
Electrical stimulation device (tens unit): An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory</description>
          </group>
        </group_list>
        <measure>
          <title>House Brackmann Scale</title>
          <description>Determined by three blinded otolaryngologist reviewing facial photos of patients with smile and eye closure. Reported as an average of the three scores. The scales ranges from 1 (normal) to 6 (most severe dysfunction)</description>
          <population>No subjects underwent subsensory electrical stimulation</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ)</title>
        <description>Quality of life is in part measured in this study using the patient reported Synkinesis Assessment Questionnaire (SAQ). The instrument consisting of 10 items asks participants how difficult certain facial activities are. Based on the average score for each domain the test gives a score between 20 (no synkinesis) to 100 (severe synkinesis, all the time).</description>
        <time_frame>Baseline, 3 months and 6 months</time_frame>
        <population>No research subjects participated in the subsensory electrical stimulation arm</population>
        <group_list>
          <group group_id="O1">
            <title>High-volt Electrical Stimulation</title>
            <description>Plan to use a monophasic waveform having 100µmsec pulse duration, 35 Hz and using tolerated voltage for a total of 20 minutes. Electrical stimulation will be produced with the Orthostim 3 device. The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral arm.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Subsensory Electrical Stimulation</title>
            <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ)</title>
          <description>Quality of life is in part measured in this study using the patient reported Synkinesis Assessment Questionnaire (SAQ). The instrument consisting of 10 items asks participants how difficult certain facial activities are. Based on the average score for each domain the test gives a score between 20 (no synkinesis) to 100 (severe synkinesis, all the time).</description>
          <population>No research subjects participated in the subsensory electrical stimulation arm</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 month outcome</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.5" spread="5.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month outcome</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7" spread="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Reported Global Quality of Life Specific to Facial Paralysis</title>
        <description>Measured by the validated quality of life patient reported questionnaire Facial Clinimetric Evaluation (FaCE) Scale with a scale from 0 (normal) to 100 (severe dysfunction). The scale encompasses facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function.</description>
        <time_frame>Baseline, 3 months and 6 months</time_frame>
        <population>No subjects were recruited for the subsensory arm</population>
        <group_list>
          <group group_id="O1">
            <title>High-volt Electrical Stimulation</title>
            <description>Plan to use a monophasic waveform having 100µmsec pulse duration, 35 Hz and using tolerated voltage for a total of 20 minutes. Electrical stimulation will be produced with the Orthostim 3 device. The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral arm.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Subsensory Electrical Stimulation</title>
            <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Global Quality of Life Specific to Facial Paralysis</title>
          <description>Measured by the validated quality of life patient reported questionnaire Facial Clinimetric Evaluation (FaCE) Scale with a scale from 0 (normal) to 100 (severe dysfunction). The scale encompasses facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function.</description>
          <population>No subjects were recruited for the subsensory arm</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.25" spread="12.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Measurements of Brow Elevation</title>
        <description>Measuring brow elevation using the MEEI FACE-gram program reported as the millimeters in decreased elevation in comparison to the unaffected side</description>
        <time_frame>Baseline and in 3 months</time_frame>
        <population>No subjects were allocated to the subsensory arm</population>
        <group_list>
          <group group_id="O1">
            <title>High-volt Electrical Stimulation</title>
            <description>Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.&#xD;
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.&#xD;
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved.</description>
          </group>
          <group group_id="O2">
            <title>Subsensory Electrical Stimulation</title>
            <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Measurements of Brow Elevation</title>
          <description>Measuring brow elevation using the MEEI FACE-gram program reported as the millimeters in decreased elevation in comparison to the unaffected side</description>
          <population>No subjects were allocated to the subsensory arm</population>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.75" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Eye Closure</title>
        <description>Measuring in millimeters of the eyelids remaining open during maximal eye closure using the MEEI FACE-gram program</description>
        <time_frame>Baseline and 3 months</time_frame>
        <population>No subjects were allocated to the subsensory arm</population>
        <group_list>
          <group group_id="O1">
            <title>High-volt Electrical Stimulation</title>
            <description>Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.&#xD;
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.&#xD;
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved.</description>
          </group>
          <group group_id="O2">
            <title>Subsensory Electrical Stimulation</title>
            <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Eye Closure</title>
          <description>Measuring in millimeters of the eyelids remaining open during maximal eye closure using the MEEI FACE-gram program</description>
          <population>No subjects were allocated to the subsensory arm</population>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Smile Excursion</title>
        <description>Measuring oral commissure exclusion using the MEEI FACE-gram program reported as the change in millimeters in the distance between the midline of the lower lip and the oral commissure in comparison between rest and smile</description>
        <time_frame>Baseline and 3 months</time_frame>
        <population>No subjects were allocated to the subsensory arm</population>
        <group_list>
          <group group_id="O1">
            <title>High-volt Electrical Stimulation</title>
            <description>Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.&#xD;
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.&#xD;
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved.</description>
          </group>
          <group group_id="O2">
            <title>Subsensory Electrical Stimulation</title>
            <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Smile Excursion</title>
          <description>Measuring oral commissure exclusion using the MEEI FACE-gram program reported as the change in millimeters in the distance between the midline of the lower lip and the oral commissure in comparison between rest and smile</description>
          <population>No subjects were allocated to the subsensory arm</population>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Facial Symmetry at Rest</title>
        <description>Measured by facial asymmetry index (FAI) at rest in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals no difference between sides and perfect symmetry. The closer a number is to 0, the higher the symmetry is. Ranges have not been published for this scale. FAI does not have a maximum score.</description>
        <time_frame>Baseline and 3 months</time_frame>
        <population>No subjects were allocated to the subsensory arm</population>
        <group_list>
          <group group_id="O1">
            <title>High-volt Electrical Stimulation</title>
            <description>Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.&#xD;
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.&#xD;
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved.</description>
          </group>
          <group group_id="O2">
            <title>Subsensory Electrical Stimulation</title>
            <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Facial Symmetry at Rest</title>
          <description>Measured by facial asymmetry index (FAI) at rest in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals no difference between sides and perfect symmetry. The closer a number is to 0, the higher the symmetry is. Ranges have not been published for this scale. FAI does not have a maximum score.</description>
          <population>No subjects were allocated to the subsensory arm</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Facial Symmetry During Smile</title>
        <description>Measured by facial asymmetry index (FAI) during smile in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals perfect symmetry and no difference in sides. The closer a number is to 0, the greater the symmetry. Ranges have not been published for this scale. FAI does not have a maximum score.</description>
        <time_frame>Baseline and 3 months</time_frame>
        <population>no subjects were allocated to the subsensory arm</population>
        <group_list>
          <group group_id="O1">
            <title>High-volt Electrical Stimulation</title>
            <description>Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.&#xD;
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.&#xD;
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved.</description>
          </group>
          <group group_id="O2">
            <title>Subsensory Electrical Stimulation</title>
            <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Facial Symmetry During Smile</title>
          <description>Measured by facial asymmetry index (FAI) during smile in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals perfect symmetry and no difference in sides. The closer a number is to 0, the greater the symmetry. Ranges have not been published for this scale. FAI does not have a maximum score.</description>
          <population>no subjects were allocated to the subsensory arm</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Tolerability</title>
        <description>Measured by a visual analog scale (VAS) which ranged from 0 to 10 where 0 stands for completely comfortable and 10 to very uncomfortable. A questionnaire designed by research team using a Likert's scale was created to measure patient tolerability.</description>
        <time_frame>3 months</time_frame>
        <population>No subjected were recruited for the subsensory arm</population>
        <group_list>
          <group group_id="O1">
            <title>High-volt Electrical Stimulation</title>
            <description>Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.&#xD;
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.&#xD;
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved.</description>
          </group>
          <group group_id="O2">
            <title>Subsensory Electrical Stimulation</title>
            <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Tolerability</title>
          <description>Measured by a visual analog scale (VAS) which ranged from 0 to 10 where 0 stands for completely comfortable and 10 to very uncomfortable. A questionnaire designed by research team using a Likert's scale was created to measure patient tolerability.</description>
          <population>No subjected were recruited for the subsensory arm</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self Reported Subject Adherence</title>
        <description>Percentage of subjected who reported full adherence, partial adherence and non-adherence confirmed by comparing to the daily diary of use.</description>
        <time_frame>3 months</time_frame>
        <population>no subjects were recruited to the subsensory electrical stimulation</population>
        <group_list>
          <group group_id="O1">
            <title>High-volt Electrical Stimulation</title>
            <description>Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.&#xD;
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.&#xD;
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved.</description>
          </group>
          <group group_id="O2">
            <title>Subsensory Electrical Stimulation</title>
            <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Self Reported Subject Adherence</title>
          <description>Percentage of subjected who reported full adherence, partial adherence and non-adherence confirmed by comparing to the daily diary of use.</description>
          <population>no subjects were recruited to the subsensory electrical stimulation</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Full adherence</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partial adherence</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non adherence</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data will be collected throughout the participants therapy. Therapy is to start during the first week of onset of facial paralysis and be used daily for three months or sooner until complete recovery is achieved. Adverse event data was collected for up to 3 months</time_frame>
      <desc>No participants were enrolled in the subsensory stimulation.</desc>
      <group_list>
        <group group_id="E1">
          <title>High-volt Electric Stimulation</title>
          <description>Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.&#xD;
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.&#xD;
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.&#xD;
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved</description>
        </group>
        <group group_id="E2">
          <title>Subsensory Electric Stimulation</title>
          <description>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.&#xD;
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Myriam Loyo</name_or_title>
      <organization>Oregon Health and Science University</organization>
      <phone>503-494-8510</phone>
      <email>loyo@ohsu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03836989
org study id: 16901
nct id: NCT03836989
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
A feasibility pilot study to exam the necessary methodology for conducting a larger clinical
      trial for Bell's Palsy patients with a poor prognosis and the use of electrical stimulation.
Here we describe a protocol for a prospective, randomized, double-blinded study to evaluate
      the effects of monophasic pulsed current ES on patients with Bell's palsy and factors
      predicting poor recovery, with a 6 month follow up. Motor level stimulation with a pulse
      duration of 100 μsec and a frequency of 35 pulses per second were chosen from focus group
      with physical therapist to treat facial paralysis and are consistent with clinical trials
      showing motor benefit after capel tunnel surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Investigator and outcome assessors are blinded to the intervention. The physical therapist that teaches the research subjects how to perform the interventions are not blinded and patients are told they are assigned to either sensory or subsensory protocols.
measure: Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions
time frame: 3 months
description: To evaluate for complete recovery, standardized photos of patients at rest, and during movement, will be evaluated by three treatment-blinded otolaryngologists. Total number of patients fully recovered over number of participants will be reported.
measure: House Brackmann Scale
time frame: Baseline, and 3 months
description: Determined by three blinded otolaryngologist reviewing facial photos of patients with smile and eye closure. Reported as an average of the three scores. The scales ranges from 1 (normal) to 6 (most severe dysfunction)
measure: Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ)
time frame: Baseline, 3 months and 6 months
description: Quality of life is in part measured in this study using the patient reported Synkinesis Assessment Questionnaire (SAQ). The instrument consisting of 10 items asks participants how difficult certain facial activities are. Based on the average score for each domain the test gives a score between 20 (no synkinesis) to 100 (severe synkinesis, all the time).
measure: Patient Reported Global Quality of Life Specific to Facial Paralysis
time frame: Baseline, 3 months and 6 months
description: Measured by the validated quality of life patient reported questionnaire Facial Clinimetric Evaluation (FaCE) Scale with a scale from 0 (normal) to 100 (severe dysfunction). The scale encompasses facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function.
measure: Objective Measurements of Brow Elevation
time frame: Baseline and in 3 months
description: Measuring brow elevation using the MEEI FACE-gram program reported as the millimeters in decreased elevation in comparison to the unaffected side
measure: Eye Closure
time frame: Baseline and 3 months
description: Measuring in millimeters of the eyelids remaining open during maximal eye closure using the MEEI FACE-gram program
measure: Smile Excursion
time frame: Baseline and 3 months
description: Measuring oral commissure exclusion using the MEEI FACE-gram program reported as the change in millimeters in the distance between the midline of the lower lip and the oral commissure in comparison between rest and smile
measure: Facial Symmetry at Rest
time frame: Baseline and 3 months
description: Measured by facial asymmetry index (FAI) at rest in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals no difference between sides and perfect symmetry. The closer a number is to 0, the higher the symmetry is. Ranges have not been published for this scale. FAI does not have a maximum score.
measure: Facial Symmetry During Smile
time frame: Baseline and 3 months
description: Measured by facial asymmetry index (FAI) during smile in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals perfect symmetry and no difference in sides. The closer a number is to 0, the greater the symmetry. Ranges have not been published for this scale. FAI does not have a maximum score.
measure: Patient Tolerability
time frame: 3 months
description: Measured by a visual analog scale (VAS) which ranged from 0 to 10 where 0 stands for completely comfortable and 10 to very uncomfortable. A questionnaire designed by research team using a Likert's scale was created to measure patient tolerability.
measure: Self Reported Subject Adherence
time frame: 3 months
description: Percentage of subjected who reported full adherence, partial adherence and non-adherence confirmed by comparing to the daily diary of use.
arm group label: High-volt electrical stimulation
arm group type: Experimental
description: Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved.
arm group label: Subsensory electrical stimulation
arm group type: Placebo Comparator
description: Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting.
intervention type: Device
intervention name: Electrical stimulation device (tens unit)
description: An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory
arm group label: High-volt electrical stimulation
arm group label: Subsensory electrical stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Myriam D Loyo, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Myriam Loyo
investigator title: Assistant Professor
mesh term: Bell Palsy
mesh term: Facial Paralysis
mesh term: Paralysis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 