NCT00845442

Dynamic Laryngeal Opening for Bilateral Vocal Fold Paralysis by an Implanted Stimulator

Dynamic Vocal Fold Abduction for Bilateral Paralysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

People who had paralysis of the vocal cords are often prevented from breathing by this problem because the cords will not open, and the patients have to wear a tracheostomy (neck breathing tube) to bypass this airway obstruction. This study examines the effects of vocal cord opening triggered by a pacemaker implanted over the chest wall. The device is connected to a nerve taken from a muscle close to the larynx (voice box) and implanted into the paralysed laryngeal muscle so it can reinnervate it. When this process is complete after a few weeks, the stimulator is turned on and the level of vocal cord opening is assessed. Airway improvement is checked by pulmonary function tests and measurements of vocal cord opening. The ultimate goal of the study is to lead to situations where patients with bilateral vocal fold paralyses could get rid of the neck breathing tube to have less complications, be more comfortable and socially acceptable.

Detailed description

Data pending

Conditions

• Vocal Cord Paralysis

Interventions

Type	Name	Description
DEVICE	pacemaker	Placement of pacemaker over the chest wall to stimulate the larynx in the neck via a tunneled electrode

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-01-01
• Completion: 2010-11-01
• First posted: 2009-02-18
• Last updated: 2022-07-22

Locations

1 site across 1 country: United States