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

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ClinicalTrials.gov Identifier: NCT02184377
Recruitment Status : Unknown
Verified July 2014 by Fang Tuan-Jen, Chang Gung Memorial Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : July 9, 2014
Last Update Posted : July 9, 2014
Sponsor:
Information provided by (Responsible Party):
Fang Tuan-Jen, Chang Gung Memorial Hospital

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
Unilateral Vocal Cord Paralysis

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.


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Study Type : Observational
Estimated 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 : August 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Group/Cohort
RLN+SLN paralysis
unilateral recurrent laryngeal and superior laryngeal nerve paralysis
RLN paralysis
unilateral recurrent laryngeal nerve paralysis



Primary Outcome Measures :
  1. laryngeal electromyography [ Time Frame: before hyaluronate injection; one month after hyaluronate injection ]

Secondary Outcome Measures :
  1. laboratory voice analysis [ Time Frame: 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) [ Time Frame: before hyaluronate injection; one month after hyaluronate injection ]
    questionnaire

  3. Short form -36 [ Time Frame: before hyaluronate injection; one month after hyaluronate injection ]
    questionnaire

  4. voice range profile [ Time Frame: 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from a tertian referral medical center.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184377


Locations
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Taiwan
Chang Gung Memorial Hospital
Linkuo, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Tuan-Jen Fang, MD Chang Gung Memorial Hospital

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Responsible Party: Fang Tuan-Jen, Director, Laryngology, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02184377     History of Changes
Other Study ID Numbers: 101_4920A3
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014
Keywords provided by Fang Tuan-Jen, Chang Gung Memorial Hospital:
quantitative laryngeal electromyography
cricothyroid muscle
unilateral vocal fold paralysis
superior laryngeal nerve
lexical tone
Mandarin
Additional relevant MeSH terms:
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Vocal Cord Paralysis
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases