Surgery for Vocal Cord Paralysis
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Unilateral Vocal Cord Paralysis |
Procedure: vocal fold medialization Procedure: vocal fold reinnervation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | Medialization Vs Reinnervation for Vocal Cord Paralysis |
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | October 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00064571
| 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 | |
| Principal Investigator: | Randal C Paniello, MD | Washington University School of Medicine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00064571 History of Changes |
| Other Study ID Numbers: | U01 DC 4681 |
| Study First Received: | July 9, 2003 |
| Last Updated: | April 21, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):
|
unilateral vocal fold paralysis |
Additional relevant MeSH terms:
|
Paralysis Vocal Cord Paralysis Cranial Nerve Diseases Laryngeal Diseases Nervous System Diseases |
Neurologic Manifestations Otorhinolaryngologic Diseases Respiratory Tract Diseases Signs and Symptoms Vagus Nerve Diseases |
ClinicalTrials.gov processed this record on March 03, 2015