NCT00064571

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2002

Typical duration for phase_3

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

April 24, 2006

Status Verified

April 1, 2006

First QC Date

July 9, 2003

Last Update Submit

April 21, 2006

Conditions

Unilateral Vocal Cord Paralysis

Keywords

unilateral vocal fold paralysis

Interventions

vocal fold medializationPROCEDURE
vocal fold reinnervationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Alabama-Birmingham

Birmingham, Alabama, United States

Location

UC-Irvine Medical Center

Irvine, California, United States

Location

George Washington University

Washington D.C., District of Columbia, United States

Location

University of Minnesota

Minneapolis, Minnesota, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Cincinnati

Cincinnati, Ohio, United States

Location

Cleveland Clinic

Cleveland, Ohio, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Location

University of Utah

Salt Lake City, Utah, United States

Location

University of Wisconsin

Madison, Wisconsin, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Location

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Randal C Paniello, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 9, 2003

First Posted

July 10, 2003

Study Start

October 1, 2002

Study Completion

October 1, 2005

Last Updated

April 24, 2006

Record last verified: 2006-04

Locations

US(12)