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

Vocal Cord Paralysis Clinical Trial

Official title:

Dynamic Vocal Fold Abduction for Bilateral Paralysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845442
• Other study ID #: 08-03-16
• Secondary ID: NIH DC-0066854-0
• Status: Completed
• Phase: N/A
• Start date: January 1, 2006
• Est. completion date: November 1, 2010

Study information

• Verified date: July 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Data pending

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 1, 2010
• Est. primary completion date: January 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Breathing difficulties from vocal cord paralyses

• Tracheostomy tube

• Ability to understand the purpose of the research

• Appropriate hand motor coordination

Exclusion Criteria:

• Lack of understanding the research

• Poor hand motor coordination

• Non-acceptance of tracheostomy

• Inability to passively move the paralyzed vocal cords

Related Conditions & MeSH terms

• Paralysis
• Vocal Cord Paralysis

Intervention

Device:
• pacemaker
Placement of pacemaker over the chest wall to stimulate the larynx in the neck via a tunneled electrode

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	Tolerance of implanted device		3-6 months