<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/NCT02184377</url>
  </required_header>
  <id_info>
    <org_study_id>101_4920A3</org_study_id>
    <nct_id>NCT02184377</nct_id>
  </id_info>
  <brief_title>The Function of Cricothyroid Muscle and Its Impaction on Mandarin Lexical Tones in Unilateral Vocal Fold Paralysis</brief_title>
  <official_title>The Function of Cricothyroid Muscle and Its Impaction on Mandarin Lexical Tones in Unilateral Vocal Fold Paralysis: a Quantified Laryngeal Electromyography Based Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mandarin Chinese phonemically distinguishes four tones, with Tone 1 having high-level pitch,&#xD;
      Tone 2 high-rising pitch, Tone 3 low-dipping pitch, and Tone 4 high-falling pitch The same&#xD;
      segmental context carries different meanings depending on the tone. The function deficit of&#xD;
      cricothyroid (CT) muscle, innervated by external branch superior laryngeal nerve (eSLN),&#xD;
      would impair the speech tone adjustment. The defect in tone adjustment may interfere with the&#xD;
      communication function in Mandarin Chinese speaker more than other language users. This may&#xD;
      explain while peripheral unilateral vocal fold paralysis (UVFP) patients with eSLN injury had&#xD;
      worse outcomes than those with sole recurrent laryngeal nerve paralysis. The neuromuscular&#xD;
      control of laryngeal muscle can be evaluated by laryngeal electromyography (LEMG). The&#xD;
      investigators have utilized a quantified LEMG (denoted Q-LEMG) in their previous research to&#xD;
      measure the neuromuscular control of thyroarytenoid- lateral cricoarytenoid (TA-LCA) adductor&#xD;
      complex. However, the task to measure the CT muscle function by Q-LEMG has not been developed&#xD;
      yet. It is of thus of utmost interest to develop a standardized task to measure the&#xD;
      neuromuscular function of CT muscle in Mandarin speakers. In Mandarin speaking patients with&#xD;
      UVFP, the lexical tone influence from CT muscle can be discovered by the technique. The&#xD;
      investigators also want to measure the lexical tone correction by conventional laryngoplasty&#xD;
      and its influence in CT muscle activity. The data of lexical tone and its correlation with CT&#xD;
      contractile activity is important in attempting pitch adjust artificial electrolarynx.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purposes: 1. Searching for a standard task to measure CT function by Q-LEMG. 2. Correlate the&#xD;
      data among Q-LEMG activity of CT muscle, lexical tone in Mandarin and vocal cord position and&#xD;
      its impaction on vocal functions. 3. Detect the influence of lexical tone from conventional&#xD;
      laryngoplasty for peripheral UVFP with eSLN injury.&#xD;
&#xD;
      Study designs: The current research is a two-year study. In the first year, the investigators&#xD;
      will develop a standardized task for quantified LEMG analysis for CT muscles which were&#xD;
      controlled by eSLN. In the second year, patients with acute UVFP will be enrolled into the&#xD;
      study. By comprehensive evaluation including Q-LEMG analysis, the impact of injection&#xD;
      laryngoplasty on tone adjustment can be identified. The results between UVFP with or without&#xD;
      CT muscle damage will also be compared.&#xD;
&#xD;
      Predictive outcomes: 1. Developing a standard tool, Q-LEMG, to measure the function CT&#xD;
      muscles. 2. Achieve the correlation of the neuromuscular control of lexical tone and CT&#xD;
      muscle. 3. Analyze the impaction of early temporary injection on speech modal tone in&#xD;
      Mandarin speakers and neuromuscular control in CT muscles. 4. Applying the data of tone and&#xD;
      CT signals to future pitch controlled artificial electrolarynx animal models.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>August 2013</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>laryngeal electromyography</measure>
    <time_frame>before hyaluronate injection; one month after hyaluronate injection</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>laboratory voice analysis</measure>
    <time_frame>before hyaluronate injection; one month after hyaluronate injection</time_frame>
    <description>The voice analysis:&#xD;
fundamental frequency, Jitter (perturbation of frequency), Shimmer (perturbation of amplitude), harmonic-to-noise ratio (HN), and s/z ratio (SZ) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>voice outcomes survey (VOS)</measure>
    <time_frame>before hyaluronate injection; one month after hyaluronate injection</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short form -36</measure>
    <time_frame>before hyaluronate injection; one month after hyaluronate injection</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>voice range profile</measure>
    <time_frame>before hyaluronate injection; one month after hyaluronate injection</time_frame>
    <description>The voice will be analyzed by computerized software. The extreme lowest and highest notes of frequencies production and the amplitude will be recorded and a voice map will be made as a plot of sound pressure level versus F0.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Unilateral Vocal Cord Paralysis</condition>
  <arm_group>
    <arm_group_label>RLN+SLN paralysis</arm_group_label>
    <description>unilateral recurrent laryngeal and superior laryngeal nerve paralysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RLN paralysis</arm_group_label>
    <description>unilateral recurrent laryngeal nerve paralysis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from a tertian referral medical center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute unilateral vocal palsy&#xD;
&#xD;
          -  Patients with clear conscious and stable mental status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with wounds on the neck or with bleeding disorder or serious cardiopulmonary&#xD;
             dysfunction&#xD;
&#xD;
          -  Patients who cannot sit for longer than 30 minutes or received other vocal cord&#xD;
             treatments before the selection&#xD;
&#xD;
          -  Pregnant and breastfeeding women&#xD;
&#xD;
          -  Patients with communication disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tuan-Jen Fang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Linkuo</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 8, 2014</last_update_submitted>
  <last_update_submitted_qc>July 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Fang Tuan-Jen</investigator_full_name>
    <investigator_title>Director, Laryngology</investigator_title>
  </responsible_party>
  <keyword>quantitative laryngeal electromyography</keyword>
  <keyword>cricothyroid muscle</keyword>
  <keyword>unilateral vocal fold paralysis</keyword>
  <keyword>superior laryngeal nerve</keyword>
  <keyword>lexical tone</keyword>
  <keyword>Mandarin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vocal Cord Paralysis</mesh_term>
    <mesh_term>Paralysis</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/NCT02184377
org study id: 101_4920A3
nct id: NCT02184377
lead sponsor: 
has dmc: Yes
Mandarin Chinese phonemically distinguishes four tones, with Tone 1 having high-level pitch,
      Tone 2 high-rising pitch, Tone 3 low-dipping pitch, and Tone 4 high-falling pitch The same
      segmental context carries different meanings depending on the tone. The function deficit of
      cricothyroid (CT) muscle, innervated by external branch superior laryngeal nerve (eSLN),
      would impair the speech tone adjustment. The defect in tone adjustment may interfere with the
      communication function in Mandarin Chinese speaker more than other language users. This may
      explain while peripheral unilateral vocal fold paralysis (UVFP) patients with eSLN injury had
      worse outcomes than those with sole recurrent laryngeal nerve paralysis. The neuromuscular
      control of laryngeal muscle can be evaluated by laryngeal electromyography (LEMG). The
      investigators have utilized a quantified LEMG (denoted Q-LEMG) in their previous research to
      measure the neuromuscular control of thyroarytenoid- lateral cricoarytenoid (TA-LCA) adductor
      complex. However, the task to measure the CT muscle function by Q-LEMG has not been developed
      yet. It is of thus of utmost interest to develop a standardized task to measure the
      neuromuscular function of CT muscle in Mandarin speakers. In Mandarin speaking patients with
      UVFP, the lexical tone influence from CT muscle can be discovered by the technique. The
      investigators also want to measure the lexical tone correction by conventional laryngoplasty
      and its influence in CT muscle activity. The data of lexical tone and its correlation with CT
      contractile activity is important in attempting pitch adjust artificial electrolarynx.
Purposes: 1. Searching for a standard task to measure CT function by Q-LEMG. 2. Correlate the
      data among Q-LEMG activity of CT muscle, lexical tone in Mandarin and vocal cord position and
      its impaction on vocal functions. 3. Detect the influence of lexical tone from conventional
      laryngoplasty for peripheral UVFP with eSLN injury.

      Study designs: The current research is a two-year study. In the first year, the investigators
      will develop a standardized task for quantified LEMG analysis for CT muscles which were
      controlled by eSLN. In the second year, patients with acute UVFP will be enrolled into the
      study. By comprehensive evaluation including Q-LEMG analysis, the impact of injection
      laryngoplasty on tone adjustment can be identified. The results between UVFP with or without
      CT muscle damage will also be compared.

      Predictive outcomes: 1. Developing a standard tool, Q-LEMG, to measure the function CT
      muscles. 2. Achieve the correlation of the neuromuscular control of lexical tone and CT
      muscle. 3. Analyze the impaction of early temporary injection on speech modal tone in
      Mandarin speakers and neuromuscular control in CT muscles. 4. Applying the data of tone and
      CT signals to future pitch controlled artificial electrolarynx animal models.
observational model: Case-Only
time perspective: Prospective
measure: laryngeal electromyography
time frame: before hyaluronate injection; one month after hyaluronate injection
measure: laboratory voice analysis
time frame: before hyaluronate injection; one month after hyaluronate injection
description: The voice analysis:
fundamental frequency, Jitter (perturbation of frequency), Shimmer (perturbation of amplitude), harmonic-to-noise ratio (HN), and s/z ratio (SZ) .
measure: voice outcomes survey (VOS)
time frame: before hyaluronate injection; one month after hyaluronate injection
description: questionnaire
measure: Short form -36
time frame: before hyaluronate injection; one month after hyaluronate injection
description: questionnaire
measure: voice range profile
time frame: before hyaluronate injection; one month after hyaluronate injection
description: The voice will be analyzed by computerized software. The extreme lowest and highest notes of frequencies production and the amplitude will be recorded and a voice map will be made as a plot of sound pressure level versus F0.
arm group label: RLN+SLN paralysis
description: unilateral recurrent laryngeal and superior laryngeal nerve paralysis
arm group label: RLN paralysis
description: unilateral recurrent laryngeal nerve paralysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Tuan-Jen Fang, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Fang Tuan-Jen
investigator title: Director, Laryngology
mesh term: Vocal Cord Paralysis
mesh term: Paralysis