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

University Hospitals (UH)

Status: Completed

Conditions: Vocal Cord Paralysis

Treatments: Device: pacemaker

Study type: Interventional

Funder types: Other

Identifiers

NCT00845442

08-03-16

IDE G980179

NIH DC-0066854-01

Details and patient eligibility

About

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.

Full description

Data pending

Enrollment: 6 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind