Remote patient testing with smartphones provides reliable, valid and sensitive measures of motor symptom severity in Parkinson’s disease patients (P3.046)

Objective: Consumer electronics enable frequent and remote, test-based assessments and ‘passive’ continuous monitoring of motor symptoms and mobility in neurological patients. We determined the reliability, sensitivity and validity of smartphone-sensor derived features to quantify motor symptoms in Parkinson’s disease (PD) patients participating in a clinical trial, as a prerequisite for use in drug development and clinical practice. Background: Remote PD symptom monitoring complements and augments physician-administered rating scales by providing previously inaccessible insights into patients’ motor symptom severity and fluctuations with heightened ecological validity. However, the feasibility, reliability and validity of these measures in the clinical trial setting are unknown. Design/Methods: All 44 PD patients (cohorts 4–6) from the Phase Ib clinical trial NCT02157714 and 35 age and gender-matched healthy controls (HC) performed daily smartphone-based assessments of sustained phonation, resting and postural tremor, dexterity, balance and gait in their homes for 24 weeks (HC: 6 weeks). Participants also carried the smartphone throughout the day, resulting in 24,104h of passive monitoring data (HC: 8,614h). Investigational drug effects and longitudinal change were not evaluated. Clinically meaningful features were extracted from the smartphone sensor data and analyzed in-depth. Results: Features showed very good test-retest reliability, differentiated PD from HC participants and were significantly associated with symptom severity as measured by the MDS-UPDRS. Importantly, most features demonstrated subclinical sensitivity, i.e. significantly heightened signals in PD patients scored as having no symptoms at site visits compared to HC. Multiple passive monitoring features demonstrated reduced mobility in PD compared to HCs. Finally, a significant effect of concomitant symptomatic medication was detected with bradykinesia sensor features. Conclusions: Remote patient testing with smartphones is feasible and provides reliable, valid, sensitive measurements of motor symptom severity and decreased mobility in PD patients. Together with real-time data transfer and advanced analytics including machine learning, this technology provides a unique window into patients’ daily motor lives. Disclosure: Dr. Lipsmeier has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Taylor has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Kilchenmann has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Wolf has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Scotland has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Schjodt-Eriksen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Cheng has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Roche TCRC Inc. Dr. Fernandez Garcia has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Siebourg-Polster has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Jin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Roche TCRC Inc. Dr. Soto has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Prothena Biosciences Inc. Dr. Verselis has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Roche TCRC Inc. Dr. Martin Facklam has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Boess has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Boess holds stock and/or stock options in F. Hoffmann-La Roche Ltd. Dr. Koller has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Prothena Biosciences Inc. Dr. Koller holds stock and/or stock options in Prothena Biosciences Inc. Dr. Grundman holds stock and/or stock options in Prothena Biosciences Inc., which sponsored research in which Dr. Grundman was involved as an investigator. Dr. Grundman has received research support from Prothena Biosciences Inc. Dr. Monsch has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Vifor Pharma; Roche; AC Immune. Dr. Monsch has received research support from Vifor Pharma, Roche. Dr. Postuma has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biotie, Roche/Prothena, Teva Neurosciences, Jazz Pharmaceuticals, Novartis Canada, Theranexus, GE HealthCare, . Dr. Ghosh has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen Inc., E-Scape Bio. Dr. Kremer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Czech has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Czech has received compensation for serving on the Board of Directors of F. Hoffmann-La Roche Ltd. Dr. Gossens has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Gossens holds stock and/or stock options in F. Hoffmann-La Roche Ltd. Dr. Lindemann has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd.