Development and Evaluation of stimulation strategies for the Improvement of the pharyngeal swallowing by an automated direct stimulation of N. hypoglossus in neurogenic swallow disorders

通过自动直接刺激神经源性吞咽障碍舌下神经来改善咽部吞咽的刺激策略的开发和评估

• 批准号: 398890253
• 负责人: Professor Dr. Rainer Seidl
• 金额: --
• 依托单位: Klinik für Hals-, Nasen- und Ohrenheilkunde
• 依托单位国家: 德国
• 项目类别: Research Grants
• 财政年份: 2018
• 资助国家: 德国
• 起止时间: 2017-12-31 至 2018-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/398890253?language=en
• 关键词: Development; Evaluation; stimulation; strategies; Improvement

The main goal of the proposed research project is to prove of concept of an implantable neuroprosthesis for the treatment of swallowing disorders. In the context of this project a controlled stimulations of the N. hypoglossus will be tried on awake patients. Those patients suffer from a neurogenic dysphagia, that prevents a sufficient elevation of the larynx. A real-time detection of the patient’s swallow intention will be used to support the voluntary onset of the swallow by electro stimulation and enable a save swallow process. The basis of the stimulation is a measurement system that has been developed under the supervision of the applicant, that can safely detect a swallow in real-time based on a bioimpedance and an electromyography measurement. This system shall be extended by a direct stimulation of the N. hypoglossus, to support the elevation of the larynx. Within the project, existing algorithms will be extended to detect swallow intentions and incomplete swallows. For that reason, the automatic detection must be adapted to patients and an inertial sensor must be integrated in the system do detect chewing movements. Further, a procedure needs to be derived that uses an endoscope and the measurement system to find the best suited position of the hypoglossus-electrode during implantation. The sufficient placement of the electrode is an important requirement for a successful stimulation. The implantation will be performed on patients that suffer from a dysphagia because of a limited elevation of the larynx (e.g. stem stroke), that can’t be further improved after a conservative therapy. This result will be evaluated by videofluoroscopy. After implantation and healing of the wounds, different stimulation strategies will be tested. It will be evaluated whether a preloading of the muscles during swallowing or imitation of the larynx movement by controlled electronic stimulation can provide the needed support of the swallowing process. Finally, a combination of both techniques will lead to an individually adapted stimulation strategy for each patient. The goal is an aspiration free swallow, with a stimulation intensity that is controlled by the stimulation system. After the evaluation is done using videofluoroscopy, the stimulation electrodes will be removed.The project will be finished after two years.

提出的研究项目的主要目标是证明可植入式神经假体治疗吞咽障碍的概念。在这个项目的背景下，将在清醒的病人身上尝试对舌下神经进行控制刺激。这些患者患有神经性吞咽困难，导致喉部无法充分抬高。患者吞咽意图的实时检测将用于通过电刺激支持吞咽的自愿发作，并使吞咽过程得以保存。刺激的基础是在申请人监督下开发的测量系统，该系统可以基于生物阻抗和肌电测量安全地实时检测燕子。这个系统应该通过直接刺激舌下肌而延伸，以支持喉部的抬高。在这个项目中，现有的算法将被扩展到检测燕子的意图和不完整的燕子。因此，自动检测必须适应患者，并且必须在系统中集成惯性传感器以检测咀嚼运动。此外，需要推导出一种程序，该程序使用内窥镜和测量系统在植入过程中找到舌下电极的最佳位置。电极的充分放置是成功刺激的重要要求。该植入将用于因喉部有限抬高而出现吞咽困难的患者（如干性中风），这些患者在保守治疗后无法进一步改善。该结果将通过透视检查进行评估。在植入和伤口愈合后，将测试不同的刺激策略。将评估在吞咽过程中肌肉的预负荷或通过受控的电子刺激模仿喉部运动是否能提供吞咽过程所需的支持。最后，这两种技术的结合将为每个病人带来一种单独适应的刺激策略。目标是无吸气的吞咽，刺激强度由刺激系统控制。在使用视频透视检查完成评估后，将移除刺激电极。这项工程将在两年后完工。