IMPLANTABLE STIMULATOR FOR PREVENTING ASPIRATION

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Severe swallowing deficits that result in aspiration occur in approximately 30% of stroke patients and are responsible for an estimated 40,000 deaths each year in the U.S. alone. For patients who cannot recover normal swallowing capabilities with standard rehabilitative exercises, irreversible surgical procedures that damage or destroy the larynx are the only remaining options. These surgeries are expensive and typically decrease the patient's quality of life. Recently, however, several animal studies have shown that electrical stimulation of the recurrent laryngeal nerve (RLN) can cause strong vocal cord adduction (VCA) and closure of the airway. The investigators propose RLN stimulation as an innovative, non- destructive technique for preventing aspiration. In Phase I, an existing implantable stimulation system will be adapted for RLN stimulation. Three post-stroke, chronically aspirating patients will be implanted with the RLN stimulation system and studied for three months. Standard clinical measurements of flexible fiberoptic laryngoscope visualization, methylene blue swallow tests, and modified barium swallow tests will be used to study RLN stimulation-induced VCA for preventing aspiration. This pilot study will demonstrate that RLN stimulation-induced VCA prevents aspiration, demonstrate the safety of the RLN stimulation, and identify essential design parameters for prototype device development in Phase II. PROPOSED COMMERCIAL APPLICATIONS: The proposed intervention is an innovative technique for treatment of aspiration. Annually, over 100,000 patients suffer from severe swallowing disorders that result in aspiration. Compared to available treatments, the proposed intervention is minimally invasive, improves patient quality of life, and reduces rehabilitation and care costs. Although initially focused on stroke-related aspiration, the treatment is also applicable to other central nervous system diseases that cause aspiration, such as Parkinson's disease, progressive supranuclear palsy, and brain tumors.