Toward objective monitoring of Parkinson's disease motor symptoms using a wearable device: wearability and performance evaluation of PDMonitor®

Abstract

Parkinson's disease (PD) is characterized by a variety of motor and non-motor symptoms. As disease progresses, fluctuations in the response to levodopa treatment may develop, along with emergence of freezing of gait (FoG) and levodopa induced dyskinesia (LiD). The optimal management of the motor symptoms and their complications, depends, principally, on the consistent detection of their course, leading to improved treatment decisions. During the last few years, wearable devices have started to be used in the clinical practice for monitoring patients' PD-related motor symptoms, during their daily activities. This work describes the results of 2 multi-site clinical studies (PDNST001 and PDNST002) designed to validate the performance and the wearability of a new wearable monitoring device, the PDMonitor®, in the detection of PD-related motor symptoms. For the studies, 65 patients with Parkinson's disease and 28 healthy individuals (controls) were recruited. Specifically, during the Phase I of the first study, participants used the monitoring device for 2–6 h in a clinic while neurologists assessed the exhibited parkinsonian symptoms every half hour using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III, as well as the Abnormal Involuntary Movement Scale (AIMS) for dyskinesia severity assessment. The goal of Phase I was data gathering. On the other hand, during the Phase II of the first study, as well as during the second study (PDNST002), day-to-day variability was evaluated, with patients in the former and with control subjects in the latter. In both cases, the device was used for a number of days, with the subjects being unsupervised and free to perform any kind of daily activities. The monitoring device produced estimations of the severity of the majority of PD-related motor symptoms and their fluctuations. Statistical analysis demonstrated that the accuracy in the detection of symptoms and the correlation between their severity and the expert evaluations were high. As a result, the studies confirmed the effectiveness of the system as a continuous telemonitoring solution, easy to be used to facilitate decision-making for the treatment of patients with Parkinson's disease.

Home-based monitoring of persons with advanced Parkinson’s disease using smartwatch-smartphone technology

“…Several home monitoring systems are available for persons with PD. For example, the PDMonitor ® is a system intended to be used for continues home monitoring of motor related symptoms of PD 26 . PDMonitor demonstrated high correlation between the severity of the majority of the symptoms and the clinicians’ evaluation.…”

A Paradigm Shift in the Management of Patients with Parkinson’s Disease

“…The evolution of monitoring devices has finally led to systems that can record all the cardinal symptoms of PD along with motor complications, including measurements from four extremities and the trunk, and giving an integrated evaluation of patient's condition [9,[29][30][31][32]. Each monitoring system is validated against clinical examination, to confirm that it delivers relevant and correct information.…”

“…Despite significant technological advancements and the incorporation of new features in monitoring devices, wearables still face certain limitations. One major pitfall lies in their accuracy in symptom detection, as there is considerable variability in sensitivity and specificity, ranging from 0.39 to 0.97, across different devices and study designs [9,55,[58][59][60]. It is not surprising that objective measurements do not always align perfectly with subjective symptom estimations, but the correlation between supervised and unsupervised motor function assessments is also not flawless [61].…”

“…Besides, the need for objective symptoms' detection that could effectively direct treatment decisions cannot always be satisfied by clinical evaluation, since this is subjective to physicians' experience and expertise, and even commonly used rating scales may be susceptible to wide inter-and intra-ratter variability [8]. Enhancement of monitoring systems has made it possible for wearable devices to accurately capture the motor symptoms of Parkinsonism, supporting objective patients' evaluation [9][10][11]. A further step for wearable technology toward "precision medicine" in Parkinson's disease is continuous monitoring with data collection at home environment, providing a detailed analysis of the patient's clinical state throughout the day, while performing their usual everyday activities as well as a quantitative assessment of the patient's journey during long periods of months and years.…”

Sensor-Based Quantification of MDS-UPDRS III Subitems in Parkinson’s Disease Using Machine Learning

“…The use of wearable technology to characterise clinical features has the potential to significantly improve the reliability, reproducibility, and accessibility of motor symptom assessment in PD [14][15][16][17]. Passive monitoring systems, for example, could autonomously assess motor symptoms through regular task-specific movements at home to reduce bias in subjective scoring [18][19][20]. Additionally, those systems could decrease the frequency of in-person clinic visits while offering a more comprehensive insight into symptoms throughout the day, thereby optimising treatment strategies and the management of PD symptoms [7,16,21].…”