Virtual exam for Parkinson’s disease enables frequent and reliable remote measurements of motor function

Abstract

Sensor-based remote monitoring could help better track Parkinson’s disease (PD) progression, and measure patients’ response to putative disease-modifying therapeutic interventions. To be useful, the remotely-collected measurements should be valid, reliable, and sensitive to change, and people with PD must engage with the technology. We developed a smartwatch-based active assessment that enables unsupervised measurement of motor signs of PD. Participants with early-stage PD (N = 388, 64% men, average age 63) wore a smartwatch for a median of 390 days. Participants performed unsupervised motor tasks both in-clinic (once) and remotely (twice weekly for one year). Dropout rate was 5.4%. Median wear-time was 21.1 h/day, and 59% of per-protocol remote assessments were completed. Analytical validation was established for in-clinic measurements, which showed moderate-to-strong correlations with consensus MDS-UPDRS Part III ratings for rest tremor (⍴ = 0.70), bradykinesia (⍴ = −0.62), and gait (⍴ = −0.46). Test-retest reliability of remote measurements, aggregated monthly, was good-to-excellent (ICC = 0.75–0.96). Remote measurements were sensitive to the known effects of dopaminergic medication (on vs off Cohen’s d = 0.19–0.54). Of note, in-clinic assessments often did not reflect the patients’ typical status at home. This demonstrates the feasibility of smartwatch-based unsupervised active tests, and establishes the analytical validity of associated digital measurements. Weekly measurements provide a real-life distribution of disease severity, as it fluctuates longitudinally. Sensitivity to medication-induced change and improved reliability imply that these methods could help reduce sample sizes needed to demonstrate a response to therapeutic interventions or disease progression.

Watching Parkinson’s disease with wrist-based sensors

“…In particular, digital biomarkers and clinical outcome assessments (COAs) may improve on qualitative evaluations for conditions like Parkinson’s disease (PD). A team from Verily (formerly Google Life Sciences) developed and validated a smartwatch-based motor exam for PD that is concordant with standard disease severity ratings, responsive to medication effects, and reliable across repeat measurements 2 . A virtual motor exam could complement in-clinic visits and passive monitoring strategies to unlock more precise insights for PD treatment.…”

Driving time-based identification of gaps in specialised care coverage: An example of neuroinflammatory diseases in Germany

“… 3 , 12 Digital Health Technologies (DHTs) 13 are increasingly being applied to support remote disease management and comprehensive research efforts, which often used to be impaired by geographic inaccessibility. 14 , 15 Well-directed deployment of DHTs in areas where currently specialised care is not available could help to reduce the overall travel time, patient burden and health outcomes significantly. With a larger number of DHTs available, 16 , 17 the digital support can increasingly be tailored to the patient's and clinician's needs and provide assistance regardless of the respective location.…”

Evidence from ClinicalTrials.gov on the growth of Digital Health Technologies in neurology trials

“…In neurological diseases such as Parkinson’s disease (PD), use of validated, reliable, and sensitive tools has already been shown to provide better data on the “real-life distribution of disease severity, as it fluctuates longitudinally” in early-stage patients 12 , 13 . DHTs can therefore facilitate new study designs 12 , improve the efficiency of clinical trials 14 – 16 , and contribute to tackling many of the challenges neurological research faces.…”

“…In neurological diseases such as Parkinson’s disease (PD), use of validated, reliable, and sensitive tools has already been shown to provide better data on the “real-life distribution of disease severity, as it fluctuates longitudinally” in early-stage patients 12 , 13 . DHTs can therefore facilitate new study designs 12 , improve the efficiency of clinical trials 14 – 16 , and contribute to tackling many of the challenges neurological research faces. As more researchers adopt such technologies, understanding the use and development of DHTs in neurological clinical trials will be valuable for investigators, practicing clinicians, and those designing patient care pathways.…”

“…This development is evident in the subset of AD trials, where recent growth in the share of trials using DHTs is consistent with increasing readiness of novel digital measures that integrate speech and cognition tracking 18 , 19 . In parallel, the repertoire of DHTs used in early-adopting subfields has also expanded, for example through potential PD monitoring technologies that now include passive tremor monitoring via wearables 12 , 13 , smartphone-based motor and vocal symptom assessments 20 , 21 , gait analysis via smart insoles 22 , and sensors for swallowing 23 .…”