IMPLANTABLE STIMULATOR FOR PREVENTING ASPIRATION

导致吸入的严重吞咽障碍发生在大约30%的中风患者中，仅在美国估计每年就有4万人死亡。对于那些无法通过标准康复训练恢复正常吞咽能力的患者，唯一剩下的选择就是采用损害或摧毁喉部的不可逆转的外科手术。这些手术费用昂贵，通常会降低患者的生活质量。然而，最近的一些动物研究表明，电刺激喉返神经(RLN)可导致强烈的声带内收(VCA)和呼吸道关闭。研究人员提出，RLN刺激是一种创新的、非破坏性的预防吸入的技术。在第一阶段，现有的植入性刺激系统将被改装用于喉返神经刺激。三名中风后慢性吸入的患者将被植入RLN刺激系统，并进行为期三个月的研究。标准的临床测量包括纤维喉镜直视、亚甲蓝吞咽试验和改良的吞钡试验，用于研究喉返神经刺激诱导的VCA预防误吸。这项先导性研究将证明刺激RLN诱导的VCA可以防止吸入，证明RLN刺激的安全性，并在第二阶段确定原型设备开发的基本设计参数。拟议的商业应用：拟议的干预是治疗吸入的一种创新技术。每年有超过10万名患者患有严重的吞咽障碍，导致吸入。与现有的治疗方法相比，建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。虽然最初的治疗重点是与中风相关的抽吸，但这种治疗也适用于其他导致抽吸的中枢神经系统疾病，如帕金森氏病、进行性核上性瘫痪和脑肿瘤。

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.