SBIR Phase II: Palatal Device Providing In-situ Sensory Feedback for Patients with Vestibular Imbalance

这个小企业创新研究（SBIR）二期项目建议开发一种先进版本的隐式无创平衡装置，可用于前庭功能障碍患者的平衡辅助。前庭患者由于前庭反馈的丧失而经历失衡，这可能导致跌倒的风险增加，活动水平降低，在某些情况下，生活明显受损。项目一期已经成功展示了第一代设备，该设备可以完全佩戴在口腔内，并为患者提供头部运动的原位感觉反馈。在第二阶段开发的原型将以市场为导向，用户友好，并且在移动环境中扩展使用。第二阶段的研究将包括1)无线控制口腔内装置的实施；2)探索提供更敏感的反馈感知，在腭界面上可靠的接触，以及长期使用的强大用户体验的设计；3)通过与前庭评估和康复方面的卫生专业人员合作，对人体受试者的设备性能进行评估。市场导向的原型将在第二阶段结束时开发出来，由前庭患者进行测试，并由更多平衡中心/诊所的医疗专业人员提供支持。如果这项计划成功，其更广泛的影响/商业潜力将是一种治疗前庭不平衡的隐式和非侵入性辅助装置。目前，还没有实用的装置可以为前庭功能丧失患者提供头部运动的原位感觉反馈。该产品将以其独特的功能抓住这一巨大的市场机遇，同时帮助前庭患者无论走到哪里都能控制平衡。对于患有前庭功能障碍的人来说，好处是巨大的，因为该设备有可能帮助他们在社交环境中获得信心，减轻与前庭功能丧失相关的次要问题，并使他们过上更健康、更愉快的生活。此外，该设备为前庭康复领域的卫生专业人员提供了新的机会，可以进行运动，不平衡和治疗方面的研究。这也为神经科学研究者研究多感觉整合在平衡和知觉学习中的作用提供了新的工具。腭刺激技术可能在其他应用中具有潜力，其中隐藏，非侵入性和免提的感觉反馈是可取的。

This Small Business Innovation Research (SBIR) Phase II project proposes to develop advanced versions of a hidden and noninvasive balance device that can be used for balance assistance for people with vestibular dysfunction. Vestibular patients experience imbalance due to loss of vestibular feedback, which may result in an increased risk of falling, reduced activity levels, and in some cases, a significantly impaired life. Phase I of the project has successfully demonstrated a first-generation device that can be worn entirely inside the oral cavity and provide in-situ sensory feedback of head movement to patients. The prototypes to be developed in Phase II will be market-oriented, user friendly, and robust for extended use in mobile environments. Research in Phase II will include 1) implementation of a wirelessly controlled intra-oral device; 2) exploration of designs that provide more sensitive perception of the feedback, reliable contact at the palatal interface, and a robust user experience for long-term use; and 3) evaluation of the device performance on human subjects through collaboration with health professionals on vestibular assessment and rehabilitation. Market-oriented prototypes will be developed by the end of Phase II, tested by vestibular patients, and supported by medical professionals from an expanded list of balance centers/clinics.The broader impact/commercial potential of this proposed project, if successful, will be a hidden and noninvasive assistive device to treat vestibular imbalance. Currently, there is no practical device currently available to provide in-situ sensory feedback of head movement for patients with vestibular loss. The product from the proposed Phase II research will capture this great market opportunity with its unique features while assisting vestibular patients in balance control wherever they go. The benefits to people with vestibular disorders are enormous as the device has the potential to help them to gain confidence in social settings, mitigate secondary problems associated with vestibular loss, and enable them to live a healthier and more enjoyable life. In addition, the device offers new opportunities for health professionals in the field of vestibular rehabilitation to conduct research on motion, imbalance, and treatment. Also, it provides a new tool for neuroscience researchers to study the role of multisensory integration on balance and perceptual learning involving use of alternative sensory feedback. The palatal stimulation technology may have potential in other applications where hidden, noninvasive, and hands-free sensory feedback is desirable.