Surgery for Vocal Cord Paralysis

Stopped early · Phase 3

Conditions studied: Unilateral Vocal Cord Paralysis

In brief

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.

Key facts

Study ID

NCT00064571

Run by

National Institute on Deafness and Other Communication Disorders (NIDCD)

People needed

300

Starts

2002-10-01

Expected to finish

2005-10-01

Last updated by the study team

2006-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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