You are viewing an expired study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials

Washington, District of Columbia

  • Unilateral Vocal Cord Paralysis

Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

U01 DC 4681


NCT ID:

NCT00064571


Secondary ID:


Study Acronym:


Brief Title:

Surgery for Vocal Cord Paralysis


Official Title:

Medialization Vs Reinnervation for Vocal Cord Paralysis


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Deafness and Other Communication Disorders (NIDCD)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:October 2002
Completion Date:October 2005
Verification Date:April 2006
Last Changed Date:April 21, 2006
First Received Date:July 9, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Procedure
Name:vocal fold medialization
Intervention Type:Procedure
Name:vocal fold reinnervation

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Deafness and Other Communication Disorders (NIDCD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.