Surgery for Vocal Cord Paralysis
- Conditions
- Unilateral Vocal Cord Paralysis
- Registration Number
- NCT00064571
- Lead Sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
UC-Irvine Medical Center
🇺🇸Irvine, California, United States
Washington University
🇺🇸St. Louis, Missouri, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
University of Alabama-Birmingham
🇺🇸Birmingham, Alabama, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States