Electrical Stimulation of the Bilaterally Paralyzed Larynx Paced with Respiration

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DESCRIPTION (provided by applicant): Bilateral vocal fold paralysis is a serious and often life-threatening medical condition. Injury to the recurrent laryngeal nerves arrests the vocal folds in a near-closed position. Conventional surgical therapies rely on partial laryngeal resection to enlarge the airway, but sacrifice voice and leave the patient at risk for aspiration. A more physiologic approach involves functional electrical stimulation of the posterior cricoarytenoid (PCA) muscle to abduct the vocal folds during inspiration. The goal of this research is to conceive an implantable laryngeal pacemaker system that will reestablish bilateral glottal opening in synchrony with inspiration. Studies will be performed initially in the canine, and then translated into the human through a clinical trial. The initial focus of the research will be to invent sensor technology that can reliably synchronize the pacemaker with each inspiratory effort. Once the most suitable stimulus electrode array has been identified, an investigation of the safety and efficacy of an implanted laryngeal pacing system will ensue in a chronic canine model. After adaptation to human anatomy, a prospective Phase I clinical trial of laryngeal pacing treatment will be compared to tracheotomy and cordotomy with respect to ventilation, voice and swallowing parameters. This new, more dynamic approach to treatment could restore normal ventilation through the mouth without alteration of voice or swallowing, and return the patient to a physically active lifestyle.