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	Treatment or Intervention	Phase
unilateral vocal fold paralysis Unilateral Vocal Cord Paralysis	Procedure: vocal fold medialization  Procedure: vocal fold reinnervation	Phase III

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

California
      UC-Irvine Medical Center, Irvine,  California,  United States; Not yet recruiting
      UCLA, Los Angeles,  California,  United States; Not yet recruiting
District of Columbia
      George Washington University, Washington,  District of Columbia,  United States; Not yet recruiting
Iowa
      University of Iowa, Iowa City,  Iowa,  United States; Not yet recruiting
Michigan
      University of Michigan, Ann Arbor,  Michigan,  United States; Not yet recruiting
Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  United States; Not yet recruiting
Missouri
      Washington University, St. Louis,  Missouri,  63110,  United States; Recruiting
Ohio
      Medical College of Toledo, Toledo,  Ohio,  United States; Not yet recruiting
Oklahoma
      University of Oklahoma, Oklahoma City,  Oklahoma,  United States; Not yet recruiting
Virginia
      East Virginia Medical School, Norfolk,  Virginia,  United States; Not yet recruiting
Washington
      University of Washington, Seattle,  Washington,  United States; Not yet recruiting
Wisconsin
      University of Wisconsin, Madison,  Wisconsin,  United States; Not yet recruiting

Study chairs or principal investigators

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

Study ID Numbers:  U01 DC 4681
Record last reviewed:  July 2003
Record first received:  July 9, 2003
ClinicalTrials.gov Identifier:  NCT00064571
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08