Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease

用于定量评估亨廷顿病运动损伤的可穿戴传感器

• 批准号: 9409865
• 负责人: Joseph T Gwin
• 金额: $ 131.49万
• 依托单位: BIOSENSICS, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9409865
• 关键词: Acceleration; Accelerometer; Activities of Daily Living; Algorithms; Americas; Businesses; Categories; Chorea; Clinic; Clinic Visits; Clinical; Clinical Research; Clinical Trials; Communication; Data; Disease; Dose; Ensure; Financial Support; Frequencies; Gait; Growth; Health Insurance Portability and Accountability Act; Home environment; Human Resources; Huntington Disease; Impairment; Individual; Industry; Intervention Trial; Investments; Letters; Manufacturer Name; Manuscripts; Measures; Methods; Monitor; Motor; Movement Disorders; Neurologic; Onset of illness; Outcome Measure; Parkinson Disease; Participant; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Phase; Phase I Clinical Trials; Pilot Projects; Preparation; Public Health; Publishing; Recruitment Activity; Research; Resources; Series; Severities; Small Business Innovation Research Grant; Societies; System; Tablet Computer; Technology; Telephone; Testing; Therapeutic Intervention; Time; Titrations; Training; Universities; Upper Extremity; Visit; Walking; Work; Wrist; base; cloud based; commercialization; cost; improved; infancy; insight; interest; motor impairment; patient population; response; sensor; technology development; telehealth; telehealth systems

ABSTRACT The principal means of measuring motor impairment in Huntington disease (HD) is the Unified Huntington's Disease Rating Scale (UHDRS) total motor score, which is subjective and categorical. Wearable sensors could enable objective, sensitive, continuous assessment of motor impairments in individuals with a variety of neurological movement disorders. This is important because large amounts of objective data acquired at a high frequency in a real-world setting could reduce the time and cost of early stage clinical trials. Clinically, wearable sensors for motor assessment during activities of daily living could be used to expedite and improve medication titration. In HD, wearable sensors that could detect subtle motor abnormalities in the premanifest phase of the disease would be valuable for monitoring early therapeutic intervention trials and could provide insight into the phase of clinical disease onset. We have recently completed a series of pilot studies (1 published article and 1 manuscript in preparation) supported by Auspex Pharmaceuticals (now part of Teva Pharmaceuticals) demonstrating that a wearable sensor on the torso can detect gait related motor impairments in HD and a wearable sensor on the wrist can identify the occurrence and severity of upper extremity chorea. In this Direct to Phase II SBIR we propose to build upon this Phase I equivalent pilot work by developing a telehealth system for continuous remote assessment of Huntington's chorea using wearable sensors. Based on our pilot research we propose to develop a system consisting of two wearables sensors to be worn on the dominant wrist and on the torso. In partnership with the University of Rochester, we will conduct a clinical study to improve and further validate algorithms for detecting chorea severity, and to evaluate whether sensor-derived measures can detect pharmacological response to anti-chorea medication or subtle motor abnormalities in the premanifest stage of HD. Participants will visit the clinic at baseline and then once a quarter for a total of 5 visits. Assessments will include the motor portion of the UHDRS, Q-motor assessment, a Timed-Up-and-Go walking test, and a series of simulated activities of daily living. This assessment will be conducted twice, on- and off-medication. Participants will wear the two sensors during in-clinic assessments and for a period of 1-week thereafter. There is a significant commercialization potential for the proposed technology. This includes pharmaceutical clinical trials, where the promise of wearable sensors has led to significant investment in the development of technologies for Parkinson's disease. However, the smaller patient population of individuals with Huntington's disease has been completely overlooked. This represents both a significant public health need and market opportunity for BioSensics. Teva Pharmaceuticals, who provided the financial support for our Phase I equivalent pilot work, and the Huntington's Disease Society of America have expressed an interest in the proposed technology and are supportive of our efforts (see Letters of Support).

抽象的 测量亨廷顿病（HD）运动障碍的主要手段是统一的亨廷顿 疾病评级量表（UHDRS）总运动评分，这是主观和分类的。可穿戴传感器可以 启用对各种个人的运动障碍的客观，敏感，连续评估 神经运动障碍。这很重要，因为大量的客观数据以高度获取 在现实世界中的频率可以减少早期临床试验的时间和成本。临床上 日常生活活动期间的可穿戴传感器可用于运动评估，可用于加快和改进 用药滴定。在高清中，可穿戴传感器可以检测到premifest中细微的电机异常 该疾病的阶段对于监测早期治疗干预试验将是有价值的，并且可以提供 深入了解临床疾病发作阶段。 我们最近完成了一系列试点研究（1个已发表的文章和1个手稿） 由Auspex Pharmaceuticals（现为Teva Pharmaceuticals的一部分）支持 躯干上的传感器可以检测高清步态相关的运动障碍，手腕上的可穿戴传感器可以 确定上肢绒毛膜的发生和严重程度。在直接到II阶段SBIR中，我们建议 建立在I阶段I等等飞行员工作的基础上，通过开发用于连续遥控的远程医疗系统 使用可穿戴传感器评估亨廷顿的唱片。根据我们的试点研究，我们建议 开发一个由两个可穿戴设备传感器组成的系统，要戴在主要的手腕和躯干上。 与罗切斯特大学合作，我们将进行一项临床研究，以改进并进一步验证 用于检测绒毛膜严重程度的算法，并评估传感器衍生的措施是否可以检测到 对抗螺旋药药物或细微运动异常的药理反应 高清。参与者将在基线访问诊所，然后每四分之一访问诊所，总共进行5次访问。评估将 包括UHDRS的电动机部分，Q-Motor评估，定时和行走测试和一系列 日常生活的模拟活动。这项评估将两次进行，并进行非治疗。 参与者将在链式评估期间佩戴这两个传感器，此后为期1周。 拟议的技术有很大的商业化潜力。这包括药物 临床试验，可穿戴传感器的承诺导致了对开发的大量投资 帕金森氏病的技术。但是，亨廷顿人的患者人数较小 疾病已被完全忽视。这既代表了巨大的公共卫生需求，又代表了市场 生物密度的机会。 Teva Pharmaceuticals，为我们的第一阶段提供了财政支持 同等的飞行员工作，美国亨廷顿氏病学会对此表示兴趣 拟议的技术并支持我们的努力（请参阅支持信）。