Fully Implantable Eye Blink Motor Neuroprosthesis for Facial Nerve Paralysis

用于治疗面神经麻痹的完全植入式眨眼运动神经假体

• 批准号: 7054991
• 负责人: Daniel McDonnall
• 金额: $ 9.94万
• 依托单位: RIPPLE, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-15 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7054991
• 关键词: clinical research; electrodes; eye; facial nerve; human subject; implant; muscle; paralysis

DESCRIPTION (provided by applicant): The goal of this program is to create a totally implantable stimulator device that can restore eye blink in patients with unilateral facial nerve paralysis. The system will record EMG from the intact eye to detect normal blink and stimulate the muscle of the paralyzed eye to create a synchronous blink. The implant will consist of a thin, ceramic package placed subcutaneously near the mastoid with a small number of surface electrodes sutured to the muscles placed with minimally-invasive facial endoscopy. In Phase I, the feasibility of the approach will be demonstrated by acutely stimulating the eye muscles of patients with facial nerve paralysis using transcutaneous electrodes. This study will confirm previous animal work in the area for human subjects and identify proper electrode placement and stimulation for functional and cosmetically acceptable eye closure. In Phase II, a fully implantable system will be developed for use in limited clinical trials with human subjects. The market for these devices is relatively small with annual patient populations on the order of a few thousand per year. For patients with chronic facial paralysis, however, the restoration of functional eye blink will provide a profound improvement in quality of life, and a reduction in the likelihood and costs of complications such as eye damage, infections and vision loss.

描述（由申请人提供）：本项目的目标是创建一种完全植入式刺激器装置，可以恢复单侧面神经麻痹患者的眨眼。该系统将记录来自完好眼睛的EMG以检测正常眨眼，并刺激麻痹眼睛的肌肉以创建同步眨眼。植入物将包括一个薄的陶瓷包装，放置在乳突附近的皮下，少量表面电极缝合到肌肉上，通过微创面部内窥镜放置。在第一阶段，该方法的可行性将通过使用经皮电极急性刺激面部神经麻痹患者的眼部肌肉来证明。本研究将确认之前在人类受试者区域的动物工作，并确定适当的电极放置和刺激，以实现功能性和美容学上可接受的眼睛闭合。在第二阶段，将开发一种完全植入式系统，用于人类受试者的有限临床试验。这些器械的市场相对较小，每年的患者数量约为几千人。然而，对于慢性面瘫患者来说，恢复功能性眨眼将大大改善生活质量，并降低并发症的可能性和成本，如眼睛损伤，感染和视力丧失。