Surgery for Vocal Cord Paralysis

Unilateral Vocal Cord Paralysis Clinical Trial

Official title:

Medialization Vs Reinnervation for Vocal Cord Paralysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00064571
• Other study ID #: U01DC004681
• Status: Terminated
• Phase: Phase 3
• First received: July 9, 2003
• Last updated: April 21, 2006
• Start date: October 2002
• Est. completion date: October 2005

Study information

• Verified date: April 2006
• Source: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Paralysis
• Unilateral Vocal Cord Paralysis
• Vocal Cord Paralysis

Intervention

Procedure:
• vocal fold medialization

• vocal fold reinnervation

Locations

Country	Name	City	State
United States	University of Alabama-Birmingham	Birmingham	Alabama
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	UC-Irvine Medical Center	Irvine	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
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	Washington University	St. Louis	Missouri
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States,