IMPLANTABLE STIMULATOR FOR PREVENTING ASPIRATION

导致误吸的严重吞咽缺陷发生在大约30%的中风患者中，并且仅在美国每年就造成估计40，000例死亡。 对于无法通过标准康复训练恢复正常吞咽能力的患者，损伤或破坏喉部的不可逆外科手术是唯一剩下的选择。 这些手术是昂贵的，通常会降低患者的生活质量。 然而，最近，一些动物研究表明，电刺激喉返神经（RLN）可引起强烈的声带内收（VCA）和气道关闭。研究者提出喉返神经刺激是一种创新的、非破坏性的防止误吸的技术.在第一阶段，现有的植入式刺激系统将适用于喉返神经刺激。三名中风后长期抽吸患者将植入RLN刺激系统并进行三个月的研究。 将使用柔性纤维喉镜可视化、亚甲蓝吞咽试验和改良钡吞咽试验的标准临床测量来研究RLN刺激诱导的VCA以防止误吸。该初步研究将证明RLN刺激诱导的VCA可防止抽吸，证明RLN刺激的安全性，并确定II期原型器械开发的基本设计参数。拟议的商业应用：拟议的干预措施是一种治疗吸入性疾病的创新技术。每年有超过100，000名患者患有导致误吸的严重吞咽障碍。 与现有的治疗方法相比，拟议的干预措施是微创的，提高了患者的生活质量，并降低了康复和护理成本。虽然最初专注于中风相关的误吸，但该治疗也适用于其他引起误吸的中枢神经系统疾病，如帕金森病，进行性核上性麻痹和脑肿瘤。

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.