Recruiting

Selective Laryngeal Reinnervation

Sponsor:

Weill Medical College of Cornell University

Code:

NCT03980275

Conditions

Bilateral Vocal Cord Paralysis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Bilateral Vocal Cord Paralysis

Study ID

NCT03980275

Start date

Dec 10, 2019

Status verified date

Apr, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in breathing function is being assessed and measured by the Dyspnea Index (DI) [ Time Frame: 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 ]
  • Change in breathing function is being assessed and measured by pulmonary function testing [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Babak Sadoughi, MD

646-962-4712bas9049@med.cornell.edu

Locations

Sean Parker Institute for the Voice

Recruiting

New York, New York, United States, 10022

Contacts

Babak Sadoughi, MD

bas9049@med.cornell.edu

Principal Investigator:

Babak Sadoughi, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • Bilateral vocal fold paralysis
  • Tracheostomy dependency
  • Glottic airway obstruction
  • Stridor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-04-21.