The study results "demonstrate the real-world feasibility of using smartwatch sensor technology in capturing and visualizing clinically relevant motor symptoms to improve the care of patients with Parkinson's disease," Dr. Peter Lin at Valley Parkinson Clinic in Los Gatos, California, said by email.
As reported in Science Translational Medicine, Dr. Lin and colleagues designed MM4PD and conducted three studies to map sensor data to ratings by a standard clinical diagnostic tool, the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. They did a pilot study with 118 PD patients that included multiple expert ratings; a longitudinal study with more than six months of data from 225 PD patients who wore the watch for an average of 11 hours daily; and a longitudinal control study with 171 elderly patients without PD.
Data from the studies were used to create PD symptom profiles that were evaluated by clinicians to determine whether the MM4PD could be used to identify symptom response to treatment changes, and whether it might be used as a decision-support tool.
MM4PD measurements correlated to clinical ratings of tremor severity and mapped to expert ratings of dyskinesia during in-clinic tasks. Specifically, during cognitive distraction tasks in the pilot study, MM4PD captured tremor in 97.7% of cases where all raters agreed.
The median tremor false-positive rate over 43,300 hours of all-day data from longitudinal control study participants was 0.25%. False positives occurred infrequently among younger, healthy controls during activities such as manual teeth brushing (8%) and playing a musical instrument (2%).
MM4PD also captured treatment-related symptom changes among 104 PD patients that matched clinicians' expectations in 94% of cases.
In the remaining 6%, symptom profiles helped the clinician identify likely clinical or pharmacological responses that may have otherwise gone unnoticed. For example, in three of six cases, the clinician determined that MM4PD detected symptom changes that were not detectable by traditional assessment but were supported by secondary clinical evidence - for example, the patient reported upper limb cramps but did not report dyskinesias.
Summing up, the authors state, "These findings demonstrate that by aligning MM4PD with standardized MDS-UPDRS assessments, the system can complement traditional examination with interpretable, quantitative and longitudinal symptom data."
Dr. Elana Clar of the Neuroscience Institute at Hackensack University Medical Center and the neurosurgery practice New Jersey Brain and Spine, commented in an email to Reuters Health, "While several groups are developing similar protocols, the importance of this paper lies in the large number of patients that were studied, the longitudinal follow up and correlation with a standardized clinical evaluation."
"In the future, this technology may be very useful in the evaluation and treatment of patients, and more importantly, accessible, given the scalability of a consumer product like this smartwatch," said Dr. Clar, who was not involved in the study.
"What the API does not report on," she said, "is monitoring of other motor symptoms in PD (i.e., rigidity, bradykinesia or gait and balance issues), which can be just as disabling for patients, and must be accounted for when looking at comprehensive, nuanced, medication management."
Although the device has not been cleared by the FDA and Apple states that it does not intend to market movement disorder monitoring as a regulated medical device, the company is offering its movement disorder API to institutions for use with patients. (https://apple.co/370kkdV)
The study was funded by Apple. Most authors are current or former employees and shareholders.
SOURCE: https://bit.ly/3cU9iuA Science Translational Medicine, online February 3, 2021
By Marilynn Larkin
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