The Function of Cricothyroid Muscle and Its Impaction on Mandarin Lexical Tones in Unilateral Vocal Fold Paralysis
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 9, 2014
July 1, 2014
1.9 years
June 23, 2014
July 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
laryngeal electromyography
before hyaluronate injection; one month after hyaluronate injection
Secondary Outcomes (4)
laboratory voice analysis
before hyaluronate injection; one month after hyaluronate injection
voice outcomes survey (VOS)
before hyaluronate injection; one month after hyaluronate injection
Short form -36
before hyaluronate injection; one month after hyaluronate injection
voice range profile
before hyaluronate injection; one month after hyaluronate injection
Study Arms (2)
RLN+SLN paralysis
unilateral recurrent laryngeal and superior laryngeal nerve paralysis
RLN paralysis
unilateral recurrent laryngeal nerve paralysis
Eligibility Criteria
Patients from a tertian referral medical center.
You may qualify if:
- Patients with acute unilateral vocal palsy
- Patients with clear conscious and stable mental status
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Linkuo, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuan-Jen Fang, MD
Chang Gung Memorial Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Laryngology
Study Record Dates
First Submitted
June 23, 2014
First Posted
July 9, 2014
Study Start
August 1, 2013
Primary Completion
July 1, 2015
Study Completion
December 1, 2015
Last Updated
July 9, 2014
Record last verified: 2014-07