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Home > "S" Clinical Trials Conditions > Surgery for Vocal Cord Paralysis  Surgery for Vocal Cord Paralysis
Surgery for Vocal Cord Paralysis
For Condition: Unilateral Vocal Cord Paralysis,unilateral vocal fold paralysis
Status: Recruiting
Sponsor(s): National Institute on Deafness and Other Communication Disorders (NIDCD) ,
Synopsis: 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.
Details: 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 acheived. 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
RandalPaniello, Principal Investigator, Washington University School of Medicine
University of Michigan *Not yet recruiting*
Ann Arbor, Michigan,
United States
Not yet recruiting Norman Hogikyan
University of Minnesota *Not yet recruiting*
Minneapolis, Minnesota,
United States
Not yet recruiting George Goding
UC-Irvine Medical Center *Not yet recruiting*
Irvine, California,
United States
Not yet recruiting Roger Crumley
Medical College of Toledo *Not yet recruiting*
Toledo, Ohio,
United States
Not yet recruiting Sid Kholsa
East Virginia Medical School *Not yet recruiting*
Norfolk, Virginia,
United States
Not yet recruiting Randall Plant
University of Washington *Not yet recruiting*
Seattle, Washington,
United States
Not yet recruiting Allen Hillel
Washington University *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Randal Paniello 314-362-8626
University of Iowa *Not yet recruiting*
Iowa City, Iowa,
United States
Not yet recruiting Henry Hoffman
George Washington University *Not yet recruiting*
Washington D.C., District of Columbia,
United States
Not yet recruiting Patty Lee
UCLA *Not yet recruiting*
Los Angeles, California,
United States
Not yet recruiting Gerald Berke
University of Oklahoma *Not yet recruiting*
Oklahoma City, Oklahoma,
United States
Not yet recruiting Keith Clark
University of Wisconsin *Not yet recruiting*
Madison, Wisconsin,
United States
Not yet recruiting Charles Ford
Additional Information:
Study ID Numbers: U01 DC 4681;
Study Start Date: October 2002
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064571
Other Unilateral Vocal Fold Paralysis Studies:
1. Surgery for Vocal Cord Paralysis
Related Studies:
Other unilateral vocal fold paralysis Clinical Trials
Other Oklahoma Clinical Trials
Other Oklahoma City Clinical Trials
Surgery for Vocal Cord Paralysis
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