Kinesia-D: Ambulatory Parkinson's Disease Dyskinesia Monitor for Drug Therapy Tit

描述（由申请人提供）：目的是设计、构建和临床评估Kinesia-D”，这是一种紧凑、便携、无线运动障碍系统，具有连续监测能力，可检测和量化帕金森病（PD）中左旋多巴诱导的舞蹈病性运动障碍或不规则快速不自主运动的严重程度。在美国，疾病发病率影响超过1，000，000人，并且继续增加。虽然在PD运动症状的管理方面取得了重大进展，但运动障碍等治疗副作用构成了关键的治疗挑战。大约30%的诊断为PD的患者在治疗5年内表现出左旋多巴诱导的运动障碍，10年时为59-100%。医疗费用与运动障碍的严重程度直接相关。与表现出严重运动障碍的患者相关的年度费用比没有症状的患者多16，000美元。运动障碍损害的评估通常在办公室访视期间使用主观测量进行。这些评定量表受到患者回忆的限制，可能无法准确反映一天中在家庭环境中经历的运动障碍的持续时间、严重程度和残疾波动。因此，目前的运动障碍评估方法可能限制临床医生有效调整药物剂量以最佳减少PD运动症状和左旋多巴诱导的运动障碍的能力。Kinesia-D提案将利用CleveMed运动传感器技术创建一个独立的便携式系统，通过临床研究捕获和量化治疗引起的舞蹈病运动障碍。假设该项目将成功地1）捕获与舞蹈病运动障碍高度相关的定量变量，2）检测是否存在舞蹈病运动障碍，无论背景自愿运动如何，以及3）证明自动检测左旋多巴诱导的运动障碍的可行性。. 公共卫生相关性：在帕金森氏病（PD）的初始发作时，左旋多巴是PD运动症状的最广泛使用和有效的治疗;然而，药物剂量副作用可引起使人衰弱的舞蹈病性运动障碍或不规则的短暂快速运动。 在临床环境之外检测和监测运动障碍严重程度的可靠方法对于帮助临床医生优化患者的药物治疗方案和在晚期PD的临床试验中监测运动障碍都是非常有价值的。 Kinesia-D将通过提供一种不限于临床办公室访视的具有成本效益的运动障碍评估方法，解决日益增长的对老年成人人群和美国超过150万PD患者医疗保险使用成本的担忧，可能有助于代表性不足的农村患者人群参与临床试验，并且可能在临床试验中显示出药物不良事件如运动障碍的早期检测，从而潜在地影响新型治疗性PD治疗的试验设计。

DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess Kinesia-D", a compact, portable, wireless movement disorder system with continuous monitoring capabilities to detect and quantify the severity of levodopa-induced choreatic dyskinesia, or irregular rapid involuntary movements, in Parkinson's disease (PD). Disease incidence affects over 1,000,000 people in the United States and continues to increase. While significant strides have been made in the management of PD motor symptoms, treatment side effects such as dyskinesia pose a key therapeutic challenge. Approximately 30% of patients diagnosed with PD exhibit levodopa-induced dyskinesia within 5 years of treatment and 59-100% by 10 years. Healthcare costs are directly correlated with dyskinesia severity. Annual costs associated with a patient exhibiting severe dyskinesia are $16,000 more than a patient with no symptoms. Assessment of dyskinesia impairment is typically performed during office visits using subjective measures. These rating scales are limited by relying on patient recall and may not accurately reflect the duration, severity, and disability fluctuations of dyskinesia experienced in the home setting throughout the day. Therefore, current dyskinesia evaluation methods may limit the clinician's ability to effectively adjust medication dose for both optimal reduction of PD motor symptoms AND levodopa-induced dyskinesia. The Kinesia-D proposal will leverage CleveMed motion sensor technology to create a stand-alone portable system to capture and quantify therapy-induced choreatic dyskinesia through a clinical study. It is hypothesized that this project will successfully 1) capture quantitative variables highly correlated to choreatic dyskinesia, 2) detect the presence or absence of choreatic dyskinesias regardless of background voluntary movements, and 3) demonstrate feasibility for automated detection of levodopa-induced dyskinesia. . PUBLIC HEALTH RELEVANCE: Upon initial onset of Parkinson's disease (PD), Levodopa is the most-widely used and effective treatment of PD motor symptoms; however, medication dose side effects can cause debilitating choreatic dyskinesia, or irregular brief rapid movements. A reliable method for detecting and monitoring the severity of dyskinesia outside of the clinical setting would be highly valuable both for aiding clinicians in optimizing medication regimens for patients and for monitoring dyskinesia in clinical trials for advanced PD. Kinesia-D will address the growing concern of Medicare usage cost in the aging adult population and over 1.5 million people in the U.S. living with PD by providing a cost effective dyskinesia assessment method that is not constrained to clinical office visits, will potentially facilitate participation of under- represented rural patient populations in clinical trials, and may show early detection of drug adverse events such as dyskinesia in clinical trials to potentially impact trial designs for novel therapeutic PD treatments.