Dynamic Laryngeal Opening for Bilateral Vocal Fold Paralysis by an Implanted Stimulator
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ClinicalTrials.gov Identifier: NCT00845442
Recruitment Status : Unknown
Verified January 2010 by University Hospitals Cleveland Medical Center. Recruitment status was: Recruiting
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.
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Ages Eligible for Study:
18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Breathing difficulties from vocal cord paralyses
Ability to understand the purpose of the research
Appropriate hand motor coordination
Lack of understanding the research
Poor hand motor coordination
Non-acceptance of tracheostomy
Inability to passively move the paralyzed vocal cords