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

July 8, 2014 updated by: Fang Tuan-Jen, Chang Gung Memorial Hospital

The Function of Cricothyroid Muscle and Its Impaction on Mandarin Lexical Tones in Unilateral Vocal Fold Paralysis: a Quantified Laryngeal Electromyography Based Research

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.

Study Overview

Status

Unknown

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Linkuo, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from a tertian referral medical center.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
laryngeal electromyography
Time Frame: before hyaluronate injection; one month after hyaluronate injection
before hyaluronate injection; one month after hyaluronate injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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) .

before hyaluronate injection; one month after hyaluronate injection
voice outcomes survey (VOS)
Time Frame: before hyaluronate injection; one month after hyaluronate injection
questionnaire
before hyaluronate injection; one month after hyaluronate injection
Short form -36
Time Frame: before hyaluronate injection; one month after hyaluronate injection
questionnaire
before hyaluronate injection; one month after hyaluronate injection
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.
before hyaluronate injection; one month after hyaluronate injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

July 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (ESTIMATE)

July 9, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

July 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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