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).

摘要 测量亨廷顿病（HD）中的运动损伤的主要手段是统一的亨廷顿运动损伤评估方法。 疾病评定量表（UHDRS）总运动评分，这是主观和分类的。可穿戴传感器可以 能够客观、敏感、持续地评估患有各种疾病的个体的运动障碍， 神经运动障碍这一点很重要，因为大量的客观数据是在高 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。在临床上， 在日常生活活动中用于运动评估的可穿戴传感器可用于加速和改善 药物滴定在HD中，可穿戴传感器可以检测预清单中的细微运动异常 疾病的早期阶段对于监测早期治疗干预试验是有价值的， 洞察临床疾病发作的阶段。 我们最近完成了一系列试点研究（1篇已发表的文章和1篇准备中的手稿） 由Auspex Pharmaceuticals（现为Teva Pharmaceuticals的一部分）支持，证明可穿戴设备 躯干上的传感器可以检测HD中与步态相关的运动损伤，手腕上的可穿戴传感器可以 确定上肢舞蹈病的发生和严重程度。在本直接至第二阶段SBIR中，我们建议 在第一阶段的试点工作基础上，开发远程保健系统， 使用可穿戴传感器评估亨廷顿舞蹈病。根据我们的试点研究，我们建议 开发一个由两个可穿戴传感器组成的系统，分别戴在主手腕和躯干上。 我们将与罗切斯特大学合作，进行临床研究，以改进和进一步验证 用于检测舞蹈病严重程度的算法，并评估传感器衍生的测量是否可以检测 对抗舞蹈病药物的药理学反应或在症状前阶段的细微运动异常 HD.受试者将在基线时访视诊所，然后每季度访视一次，共5次。评估将 包括UHDRS的运动部分、Q运动评估、定时起身行走测试和一系列 模拟日常生活活动。该评估将进行两次，分别在服药和停药期间进行。 受试者将在门诊评估期间佩戴两个探头，并在此后佩戴1周。 拟议的技术具有巨大的商业化潜力。其中包括制药 临床试验，其中可穿戴传感器的承诺导致了对开发的重大投资， 帕金森病的治疗技术。然而，患有亨廷顿舞蹈症的患者人数较少， 疾病被完全忽视了。这代表了一个重要的公共卫生需求和市场 生物传感器的机会Teva制药公司为我们的第一阶段提供了资金支持， 美国亨廷顿氏病协会（Huntington's Disease Society of America）也表达了对这项研究的兴趣。 建议的技术，并支持我们的努力（见支持信）。