A novel wearable platform to assess cognitive-motor performance

摘要 阿尔茨海默病（AD）临床研究的最新转变是从临床诊断转向 神经保护疗法的发展突出了对强大和快速管理的认知的需要， 一种评估工具，能够识别处于认知能力下降最早阶段的个体， 随着时间的推移，认知运动表现会发生微妙的变化。在这种情况下，身体虚弱加上 认知障碍（称为“认知脆弱”）被证明是一个强大的和独立的预测因素， 随着时间的推移认知能力下降。国际老年学和老年医学协会以及 国际营养与老龄化学会建议使用认知脆弱性测量， 确定MCI进展为痴呆/AD和丧失独立性的途径。 我们最近开发了一种新的认知脆弱性测量工具，该工具基于 可穿戴传感器连接到病人的小腿和虚拟现实软件。使用此工具进行的评估 平台是工具化的跟踪制作任务或iTMT。这种创新的工具， 运动和认知表现的评估被用来检查患者执行运动的能力。 在虚拟环境中进行跟踪任务。评估基于测量执行时间和用户 在涉及视觉搜索，扫描，处理速度，心理灵活性， 和执行功能。在执行每项任务时，通过测量踝关节速度来量化运动性能 认知表现通过评估运动规划错误、工作记忆和所需时间来量化 来完成任务在我们最近发表在《老年学》上的试点研究中，我们证明， iTMT可用于评估老年人的认知运动表现并识别aMCI和AD。 此外，我们已经证明了iTMT确定虚弱状态的能力。iTMT可以用作 双任务步行测试的替代测试，以评估和量化老年人的认知能力。的 拟议平台的独特好处包括客观性、低成本、节省时间、多方面评估， 并且易于使用。 这项STTR第一阶段研究的目的是将这项创新和专利技术从贝勒大学转移到 医药向BioSensics LLC提供进一步的开发、临床试验和商业化。BioSensics是一家 一家私人控股的生物医学公司，专门从事医疗保健可穿戴技术， 迅速将政府研究资金转化为商业化的医疗设备和技术。 此处提出的iTMT产品将添加到当前的床旁评估工具中 由BioSensics商业化，其中包括步态和跌倒风险（LEGSys），平衡（BalanSens） 脆弱度（Frailty Meter）

ABSTRACT The recent shift in Alzheimer’s disease (AD) clinical research from clinical diagnosis toward the goal of developing neuroprotective therapies has highlighted the need for a robust and rapidly-administered cognitive assessment tool capable of identifying individuals in the earliest stages of cognitive decline and measuring subtle changes in cognitive-motor performance over time. In this context, physical frailty together with cognitive impairment (known as ‘cognitive frailty’) is shown to be a strong and independent predictor of cognitive decline over time. The International Association of Gerontology and Geriatrics, as well as The International Academy on Nutrition and Aging have recommended the use of cognitive frailty measurement for determining pathways of MCI progression toward dementia/AD, and loss of independence. We have recently developed a novel cognitive frailty measurement tool that is based on a combination of a wearable sensor attached to patient’s shin and virtual reality software. The assessment performed using this platform is the Instrumented Trail Making Task or iTMT . This innovative tool for objective and simultaneous assessment of both motor and cognitive performance is used to examine the ability of the patient to execute a trail-making task in a virtual environment. The assessment is based on measuring the execution time and user performance during multiple tasks that involve visual search, scanning, speed of processing, mental flexibility, and executive function. In performing each task, motor performance is quantified by measuring ankle velocity and cognitive performance is quantified by assessing motor-planning error, working memory, and time needed to complete the task. In our pilot study, which was recently published in Gerontology, we demonstrated that iTMT can be used to assess cognitive-motor performance and identify aMCI and AD in older adults. Furthermore, we have demonstrated the ability of iTMT to determine frailty status. The iTMT could be used as an alternative test to the dual-task walking test to assess and quantify cognitive frailty in older adults. The unique benefits of the proposed platform include objectivity, low cost, time-savings, multifaceted assessment, and being easy to use. This STTR Phase I study aims to transfer this innovative and patented technology from Baylor College of Medicine to BioSensics LLC for further development, clinical testing, and commercialization. BioSensics is a privately-held biomedical firm specialized in wearable technologies for healthcare, with a proven record of rapidly transitioning governmental research funding into commercialized medical devices and technologies. The iTMT product proposed here will be added to the current line of point-of-care assessment tools commercialized by BioSensics, which includes devices for gait and fall risk (LEGSys), balance (BalanSens) and Frailty (Frailty Meter).