The Function of Cricothyroid Muscle and Its Impaction on Mandarin Lexical Tones in Unilateral Vocal Fold Paralysis

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02184377
Collaborator
(none)
60
1
28
2.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Aug 1, 2013
    Anticipated Primary Completion Date :
    Jul 1, 2015
    Anticipated Study Completion Date :
    Dec 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    RLN+SLN paralysis

    unilateral recurrent laryngeal and superior laryngeal nerve paralysis

    RLN paralysis

    unilateral recurrent laryngeal nerve paralysis

    Outcome Measures

    Primary Outcome Measures

    1. laryngeal electromyography [before hyaluronate injection; one month after hyaluronate injection]

    Secondary Outcome Measures

    1. laboratory voice analysis [before hyaluronate injection; one month after hyaluronate injection]

      The voice analysis: fundamental frequency, Jitter (perturbation of frequency), Shimmer (perturbation of amplitude), harmonic-to-noise ratio (HN), and s/z ratio (SZ) .

    2. voice outcomes survey (VOS) [before hyaluronate injection; one month after hyaluronate injection]

      questionnaire

    3. Short form -36 [before hyaluronate injection; one month after hyaluronate injection]

      questionnaire

    4. voice range profile [before hyaluronate injection; one month after hyaluronate injection]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with acute unilateral vocal palsy

    • Patients with clear conscious and stable mental status

    Exclusion Criteria:
    • Patients with wounds on the neck or with bleeding disorder or serious cardiopulmonary dysfunction

    • Patients who cannot sit for longer than 30 minutes or received other vocal cord treatments before the selection

    • Pregnant and breastfeeding women

    • Patients with communication disorder

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chang Gung Memorial Hospital Linkuo Taiwan

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital

    Investigators

    • Principal Investigator: Tuan-Jen Fang, MD, Chang Gung Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fang Tuan-Jen, Director, Laryngology, Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT02184377
    Other Study ID Numbers:
    • 101_4920A3
    First Posted:
    Jul 9, 2014
    Last Update Posted:
    Jul 9, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by Fang Tuan-Jen, Director, Laryngology, Chang Gung Memorial Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 9, 2014