Parkinson’s disease medication adjustments based on wearable device information compared to other methods: randomized clinical trial

Abstract

Parkinson's disease; Wearable device

Enfermedad de Parkinson; Dispositivo portátil

Malaltia de Parkinson; Dispositiu portàtil

Parkinson's disease (PD) is characterized by motor fluctuations, with alternating periods of good ("ON") and poor ("OFF") motor function. Monitoring these fluctuations is crucial for optimizing treatment, yet traditional methods rely on subjective patient reports. This multicenter, single-blind, cluster-randomized trial evaluated the effectiveness of three monitoring approaches in real-world clinical practice. Neurologists from 35 centers were randomized into three groups: one using clinical visit data alone, another incorporating Hauser diary entries, and a third integrating Parkinson's Holter (STAT-ON®) reports. A total of 156 patients were recruited. Changes in 'OFF time' from baseline to 26 weeks were minimal and non-significant across groups. Secondary outcomes, including 'ON time,' dyskinesia, and quality-of-life scores, showed no significant differences. These findings suggest that the choice of motor fluctuation monitoring method may not significantly impact clinical outcomes, underscoring the need for a broader understanding of how these monitoring tools are integrated and utilized in real-world settings. Trial registration: NCT04176302 (November 21, 2019 - ClinicalTrials.gov).

This work is supported by the Instituto de Salud Carlos III [DTS17/00195], the "A way to make Europe" European Fund for Regional Development, and AbbVie S.L.U.The authors would like to thank the i2e3 Procomms (Barcelona, Spain) team and especially, Jesús Loureiro, Ph.D., and Sara Cervantes, Ph.D., for providing medical writing support during the manuscript preparation.