No abstract

Innovative tools are urgently needed to accelerate the evaluation and subsequent approval of novel treatments that may slow, halt, or reverse the relentless progression of Parkinson disease (PD). Therapies that intervene early in the disease continuum are a priority for the many candidates in the drug development pipeline. There is a paucity of sensitive and objective, yet clinically interpretable, measures that can capture meaningful aspects of the disease. This poses a major challenge for the development of new therapies and is compounded by the considerable heterogeneity in clinical manifestations across patients and the fluctuating nature of many signs and symptoms of PD. Digital health technologies (DHT), such as smartphone applications, wearable sensors, and digital diaries, have the potential to address many of these gaps by enabling the objective, remote, and frequent measurement of PD signs and symptoms in natural living environments. The current climate of the COVID-19 pandemic creates a heightened sense of urgency for effective implementation of such strategies. In order for these technologies to be adopted in drug development studies, a regulatory-aligned consensus on best practices in implementing appropriate technologies, including the collection, processing, and interpretation of digital sensor data, is required. A growing number of collaborative initiatives are being launched to identify effective ways to advance the use of DHT in PD clinical trials. The Critical Path for Parkinson’s Consortium of the Critical Path Institute is highlighted as a case example where stakeholders collectively engaged regulatory agencies on the effective use of DHT in PD clinical trials. Global regulatory agencies, including the US Food and Drug Administration and the European Medicines Agency, are encouraging the efficiencies of data-driven engagements through multistakeholder consortia. To this end, we review how the advancement of DHT can be most effectively achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies.

Background The natural fluctuation of motor symptoms of Parkinson's disease (PD) makes judgement of any change challenging and the use of clinical scales such as the International Parkinson and Movement Disorder Society (MDS)‐UPDRS imperative. Recently developed commodity mobile communication devices, such as smartphones, could possibly be used to assess motor symptoms in PD patients in a convenient way with low cost. We provide the first report on the development and testing of stand‐alone software for mobile devices that could be used to assess both tremor and bradykinesia of PD patients. Methods We assessed motor symptoms with a custom‐made smartphone application in 14 patients and compared the results with their MDS‐UPDRS scores. Results We found significant correlation between five subscores of MDS‐UPDRS (rest tremor, postural tremor, pronation‐supination, leg agility, and finger tapping) and eight parameters of the data collected with the smartphone. Conclusions These results provide evidence as a proof of principle that smartphones could be a useful tool to objectively assess motor symptoms in PD in clinical and experimental settings.

The Internet of Things (IoT) is a computing paradigm whereby everyday life objects are augmented with computational and wireless communication capabilities, typically through the incorporation of resource-constrained devices including sensors and actuators, which enable their connection to the Internet. The IoT is seen as the key ingredient for the development of smart environments. Nevertheless, the current IoT ecosystem offers many alternative communication solutions with diverse performance characteristics. This situation presents a major challenge to identifying the most suitable IoT communication solution(s) for a particular smart environment. In this paper we consider the distinct requirements of key smart environments, namely the smart home, smart health, smart cities and smart factories, and relate them to current IoT communication solutions. Specifically, we describe the core characteristics of these smart environments and then proceed to provide a comprehensive survey of relevant IoT communication technologies and architectures. We conclude with our reflections on the crucial features of IoT solutions in this setting and a discussion of challenges that remain open for research.