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. 2025 Aug 20;11(1):249.
doi: 10.1038/s41531-025-00977-2.

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

Alejandro Rodríguez-Molinero  1 , Carlos Pérez-López  2 , Nuria Caballol  3 , Mariateresa Buongiorno  4 , María Asunción Ávila Rivera  3 , Núria López Ariztegui  5 , Lydia López-Manzanares  6 , Jorge Hernández-Vara  4   7 , Àngels Bayes-Rusiñol  8 , Alexandre Gironell Carreró  9 , María Álvarez Saúco  10 , Elisabet Franquet Gomez  11 , David A Pérez-Martínez  12 , Sonia Escalante Arroyo  13 , Silvia Martí-Martínez  14 , Pablo Mir  15   16   17 , José Mª Salom Juan  18 , Juan Carlos Martínez-Castrillo  19 , Cristian Tebé  20 ; MoMoPa-EC Research Group
Collaborators, Affiliations

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

Alejandro Rodríguez-Molinero et al. NPJ Parkinsons Dis. .

Abstract

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).

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Conflict of interest statement

Competing interests: C.P.L., A.R.M., J.H.V., and A.B. are shareholders of Sense4Care the company that markets the tested device. The remaining declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of participating neurologists and study patients.
See this image and copyright information in PMC

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