Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, The Netherlands.
Department of Neurological Sciences, Rush University, Chicago, IL, USA.
Ann Neurol. 2023 Apr;93(4):681-685. doi: 10.1002/ana.26612. Epub 2023 Feb 9.
It is challenging to reliably assess the motor features of Parkinson's disease in real-time. This has motivated the search for new digital outcomes that can objectively and remotely measure the severity of parkinsonian motor impairments over an extended period of time. The United States Food and Drug Administration (FDA) has recently granted a 510(k) clearance to the Rune Labs Kinematics System, an ambulatory, smartwatch-based monitoring system to remotely track tremor and dyskinesias in persons with Parkinson's disease. The FDA clearance means that this new digital approach can be regarded as being safe for use in daily practice, with acceptable correlations to clinically based measures. However, the immediate implications for clinicians are limited, because it remains to be demonstrated whether the digital signals correlate well to clinically meaningful outcomes at patient level. The impact on research is also restricted for now, as more validation studies are needed before this new digital approach can be used as primary or secondary endpoint in clinical trials. ANN NEUROL 2023;93:681-685.
实时可靠地评估帕金森病的运动特征具有挑战性。这促使人们寻找新的数字结果，可以在较长时间内客观、远程地测量帕金森运动障碍的严重程度。美国食品和药物管理局（FDA）最近批准了 Rune Labs Kinematics System 的 510(k)许可，这是一种基于可穿戴智能手表的监测系统，可远程跟踪帕金森病患者的震颤和运动障碍。FDA 的许可意味着这种新的数字方法可以在日常实践中安全使用，与基于临床的测量具有可接受的相关性。然而，对临床医生的直接影响是有限的，因为仍需要证明数字信号是否与患者层面的临床有意义的结果很好地相关。对研究的影响也受到限制，因为在这种新的数字方法可以作为临床试验的主要或次要终点之前，还需要进行更多的验证研究。ANN NEUROL 2023;93:681-685.
