Surgery for Vocal Cord Paralysis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Unilateral vocal fold paralysis (UVFP) is caused by injury to the nerve to the affected vocal fold. The injury to the vocal fold makes the affected person's voice sound "breathy". Voice therapy is usually tried first, and, if unsuccessful, surgical treatment is considered. The standard surgical treatment is called vocal fold medialization and aims to bring the injured cord to the midline. An alternative surgical treatment, vocal fold reinnervation, aims to bring a new nerve supply to the injured vocal fold. The reinnervation operation, which has some potential advantages over the medialization operation also requires several months for final results to be gained. The goal of this multicenter, randomized clinical trial is to see which of the two surgical treatments produces a better outcome.

In order to participate in this study patients with UVFP must meet all entry criteria and must be released from voice therapy by a speech-language pathologist. Information collected for the study (pre-surgery, and at 6 and 12 months after surgery) includes voice recordings, movies made of vocal fold function, airflow and pressure measurements of the voicebox, and an outcomes questionnaire.

Condition or disease	Intervention/treatment	Phase
Unilateral Vocal Cord Paralysis	Procedure: vocal fold medialization; Procedure: vocal fold reinnervation	Phase 3

Detailed Description:

Unilateral vocal fold paralysis (UVFP) is caused by injury to the recurrent laryngeal nerve. Patients with UVFP may have significant impairment of vocal fold function, including a breathy paralytic dysphonia. There are several available approaches for the treatment of this condition. Vocal fold medialization is currently used by most otolaryngologists and is probably the standard of care for treating UVFP. An alternative approach is laryngeal reinnervation, which has a number of potential advantages over medialization but which requires several months before a final result is achieved. The primary goal of this multicenter, randomized clinical trial is to determine which approach produces a better outcome.

Patients with UVFP meeting all inclusion criteria and released from therapy by a speech-language pathologist will be randomized into either the medialization arm or the reinnervation arm. The data collection protocol consists of voice recordings, aerodynamic measurements, electroglottography, videostroboscopy, and a clinical outcomes questionnaire collected pre-treatment and at 6 and 12 months post-treatment.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Primary Purpose:	Treatment
Official Title:	Medialization Vs Reinnervation for Vocal Cord Paralysis
Study Start Date :	October 2002
Study Completion Date :	October 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

• clinical diagnosis of unilateral vocal fold paralysis
• older than 18 years of age
• intact ansa cervicalis and recurrent laryngeal nerves
• life expectancy of greater than 2 years
• onset of the vocal fold paralysis within 2 years of the time of surgery
• no gelfoam injection for at least 4 months prior to initial data collection
• able to give informed consent
• willing and able to return for 6 and 12 month data collection sessions
• able and willing to perform questionnaire (by mail) 18 months after surgery

Exclusion criteria

• abnormal non-paralyzed fold
• other disorders affecting the larynx (voice box), such as multiple sclerosis, myasthenia gravis, spasmodic dysphonia, or essential voice tremor
• prior surgery to either vocal fold
• previous or planned irradiation of the voicebox

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Alabama
University of Alabama-Birmingham
Birmingham, Alabama, United States
United States, California
UC-Irvine Medical Center
Irvine, California, United States
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
United States, Utah
University of Utah
Salt Lake City, Utah, United States
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States

Sponsors and Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Principal Investigator:	Randal C Paniello, MD	Washington University School of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00064571 History of Changes
Other Study ID Numbers:	U01DC004681 ( U.S. NIH Grant/Contract )
First Posted:	July 10, 2003
Last Update Posted:	April 24, 2006
Last Verified:	April 2006

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

unilateral vocal fold paralysis

Additional relevant MeSH terms:

Paralysis; Vocal Cord Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms	Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases