Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis

Bilateral Vocal Cord Paralysis Clinical Trial

Official title:

Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03980275
• Other study ID #: 1806019347
• Status: Recruiting
• Start date: December 10, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: Weill Medical College of Cornell University
• Contact: Babak Sadoughi, MD
• Phone: 646-962-4712
• Email: bas9049[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective observational study examining the treatment outcomes of selective laryngeal reinnervation procedures for patients with bilateral vocal fold paralysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 30, 2025
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-70

• Patients with bilateral vocal fold paralysis without any improvement for 6 months

Exclusion Criteria:

• Patients with neck or chest radiation

• Patients with severe respiratory compromise

• Patients with cricoarytenoid ankylosis

• Patients with pacemakers

• Patients who are pregnant

• Patients with cochlear implant, or any nerve stimulator implants

Related Conditions & MeSH terms

• Bilateral Vocal Cord Paralysis
• Paralysis
• Vocal Cord Paralysis

Locations

Country	Name	City	State
United States	Sean Parker Institute for the Voice	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in breathing function is being assessed and measured by the Dyspnea Index (DI)	The DI is a standardized and validated tool to quantify patients' symptoms of upper airway dyspnea. It's a 10-item questionnaire. The lowest score is 0, which indicates that the patient is never experiencing dyspnea symptoms, and the highest is 40, which indicates that the patient is always experiencing dyspnea symptoms.	Pre-surgery and then post-surgery at 1 week, 1 month, 3 months and every 3 months thereafter up to 18 months, then at 24 months
Primary	Change in breathing function is being assessed and measured by pulmonary function testing	Pulmonary function testing will measure the total inspiratory and expiratory tidal volumes.	Pre-surgery and then post-surgery at 1 week, 1 month, 3 months and every 3 months thereafter up to 18 months, then at 24 months