- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00064571
Surgery for Vocal Cord Paralysis
Medialization Vs Reinnervation for Vocal Cord Paralysis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States
- University of Alabama-Birmingham
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California
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Irvine, California, United States
- UC-Irvine Medical Center
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District of Columbia
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Washington, District of Columbia, United States
- George Washington University
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Minnesota
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Minneapolis, Minnesota, United States
- University of Minnesota
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University
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Ohio
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Cincinnati, Ohio, United States
- University of Cincinnati
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Cleveland, Ohio, United States
- Cleveland Clinic
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Oklahoma
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Oklahoma City, Oklahoma, United States
- University of Oklahoma
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Pennsylvania
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Philadelphia, Pennsylvania, United States
- Thomas Jefferson University
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Utah
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Salt Lake City, Utah, United States
- University of Utah
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Wisconsin
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Madison, Wisconsin, United States
- University of Wisconsin
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Milwaukee, Wisconsin, United States
- Medical College Of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Investigators
- Principal Investigator: Randal C Paniello, MD, Washington University School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U01DC004681 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Unilateral Vocal Cord Paralysis
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University of FloridaCompletedUnilateral Vocal Cord Paralysis | Unilateral Vocal Cord ParesisUnited States
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Lawson Health Research InstituteUnknownUnilateral Vocal Cord LesionsCanada
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Cliniques universitaires Saint-Luc- Université...Active, not recruitingUnilateral Vocal Cord ParalysisBelgium
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Royal National Throat, Nose and Ear HospitalUniversity College London Hospitals; University College Joint Research Office; NIHR Research for Patient Benefit (RfPB) and other collaboratorsCompletedVocal Cord Paralysis UnilateralUnited Kingdom
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APrevent Biotech GmbHCompletedParalysis, Unilateral, Vocal CordAustria
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Chang Gung Memorial HospitalUnknownUnilateral Vocal Cord ParalysisTaiwan
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Chang Gung Memorial HospitalUnknownUnilateral Vocal Cord ParalysisTaiwan
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Chang Gung Memorial HospitalNational Science Council, TaiwanCompletedParalysis, Unilateral, Vocal CordTaiwan
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APrevent Biotech GmbHRecruitingParalysis, Unilateral, Vocal CordAustria, United States, Germany
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Hospital General Universitario Gregorio MarañonCompletedVocal Cord Paralysis, UnilateralSpain
Clinical Trials on vocal fold medialization
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University Hospital, Strasbourg, FranceUnknown
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University of FloridaCompletedUnilateral Vocal Cord Paralysis | Unilateral Vocal Cord ParesisUnited States
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Muhammad RashidCompletedVocal Cord Paralysis | Presbylarynges | Phonasthenia | Idiopathic Vocal Cord Paralysis | Ca LarynxPakistan
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PfizerCompleted
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NYU Langone HealthCompleted
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Galderma R&DEnrolling by invitationWrinkleUnited States
-
Vrushali AngadiCompleted
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Far Eastern Memorial HospitalCompletedAged | Dysphonia | Speech Therapy
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Azienda Ospedaliero Universitaria Maggiore della...UnknownIntubation Complication | Vocal Cord Dysfunction | Intubation;Difficult | Vocal Tone DisorderItaly
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Tehran University of Medical SciencesUnknownSinusitis | Nasal PolyposisIran, Islamic Republic of