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、便携式、无线运动障碍系统，具有连续监测能力，可检测和量化左多巴诱导的帕金森病（PD）的舞蹈性运动障碍或不规则快速不自主运动的严重程度。在美国，这种疾病的发病率超过100万人，而且还在继续增加。虽然在PD运动症状的治疗方面取得了重大进展，但治疗副作用，如运动障碍，是一个关键的治疗挑战。大约30%被诊断为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年后为59-100%。医疗费用与运动障碍的严重程度直接相关。一个表现出严重运动障碍的患者的年费用比一个没有症状的患者多出16000美元。运动障碍障碍的评估通常在办公室访问期间使用主观测量进行。这些评定量表依赖于患者回忆，可能不能准确反映全天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会限制临床医生有效调整药物剂量以最佳减轻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运动障碍。假设该项目将成功地1)捕获与舞蹈运动障碍高度相关的定量变量，2)检测舞蹈运动障碍的存在或不存在，而不考虑背景自主运动，3)证明自动检测左旋多巴诱导的运动障碍的可行性。

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.