Reliable and Safe Laser Pointing for People with Locked-in Syndrome

描述(申请人提供)：拟议的项目使行动非常有限的人能够使用激光安全地控制辅助设备。这项第一阶段快速通道研究的重点是开发一种定制的、低成本的感光材料，它可以检测来自激光的光。在第一阶段获得的基本科学知识将使研究团队能够可靠地制造激光传感表面。第一阶段的目标是无故障地生产五个信噪比至少为3：1的激光传感表面。第二阶段快速通道研究的重点是通过完成三项主要任务来展示针对闭锁综合征患者的安全激光指向系统的可靠性、安全性和有效性。首先，技术团队将继续工作，优化第一阶段开发的激光传感表面，并生产用于临床评估的可靠原型。其次，我们必须设计一款重量轻、易于佩戴和指向的安全激光笔。第三，患有闭锁综合征(LIS)的个人、他们的家人以及照顾他们的专业人员将在18个月的临床研究中对这些原型进行全面评估。这项评估将从培训辅助技术使用和成功地将技术融入他们的生活的角度，展示原型的可靠性和安全性，以及安全激光指向系统在满足服务不足的LIS人群的辅助技术需求方面的有效性。SAFE激光指向系统是一种重要的、创新的访问方法，可用于各种残疾原因，包括脑瘫、肌萎缩侧索硬化症、脑干中风、创伤性脑损伤和重症肌无力。它使许多行动受限的人可以实现电子技术的直接门禁，避免使用单开关扫描。在这项研究完成后，我们将实施一个精心设计的快速商业化计划，将这项技术提供给需要它的人。

DESCRIPTION (provided by applicant): The proposed project enables people with very limited movement to use a laser to control assistive devices - safely. This Phase 1 Fast-Track research focuses on developing a custom, low-cost, photosensitive material that detects the light from a laser. The fundamental scientific knowledge gained during Phase 1 will enable the research team to manufacture laser-sensing surfaces reliably. The goal for Phase 1 is to produce, without failure, five laser-sensing surfaces with a signal-to-noise ratio of at least 3:1. The Phase 2 Fast-Track research focuses on demonstrating the reliability, safety, and efficacy of the Safe- laser Pointing System for individuals with Locked-in Syndrome by completing three major tasks. First, the technical team will continue its work by optimizing the laser-sensing surface developed in Phase 1 and producing reliable prototypes for clinical evaluation. Second, we must design a Safe-laser pointer that is lightweight, and easy to wear and point. Third, individuals with Locked-in Syndrome (LIS), their families, and the professionals that care for them will comprehensively evaluate these prototypes over an 18-month clinical study. This evaluation will demonstrate the reliability and safety of the prototypes, and the efficacy of the Safe-laser Pointing System for meeting the assistive technology needs of the underserved LIS population, both from the perspective of training assistive technology use and successfully integrating technology into their lives. The Safe-laser Pointing System is an important, innovative, access method for a wide range of disability etiologies, including cerebral palsy, amyotrophic lateral sclerosis, brainstem stroke, traumatic brain injury, and myasthenia gravis. It enables many people with restricted movement to achieve direct access control of electronic technology and avoid the use of single-switch scanning. Upon completion of this research, we will implement a well-conceived and swift commercialization plan to make this technology available to the people that need it.