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

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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Publication Details

Journal
npj Parkinson s Disease
Published
2025-08-20
DOI
https://doi.org/10.1038/s41531-025-00977-2
Citations
2
Primary Topic
Parkinson's Disease Mechanisms and Treatments
Type
article
Field-Weighted Citation Impact
2.78

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article

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

Laura Muñoz‐Delgado, Teresa Muñoz Ruíz, Ignacio Álvarez, Esteban Peña et al.
2 citations
npj Parkinson s Disease
Parkinson's Disease Mechanisms and Treatments
2.78
article

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

Laura Muñoz‐Delgado, Teresa Muñoz Ruíz, Ignacio Álvarez, Esteban Peña, Silvia Jesús, Astrid Adarmes‐Gómez, Antonio Hernández Vidal, Isabel González Aramburu, S. Novo Ponte, Daniel Macías‐García, Marina Mata Álvarez‐Santullano, Sara Lucas del Pozo, Ramiro Álvarez-Ramo, Eduardo Ruíz, María Isabel Morales‐Casado, Pau Pástor, Jon Infante, A. Planas-Ballvé, Ernest Balaguer, A. Cots Foraster, Aline Rodrigues Pinto, E. López Valdés, Anna Prats, Núria López Ariztegui, Esther Blanco Vicente, Carlos Pérez‐López, Ana Vinagre‐Aragón, Núria Caballol, David A. Pérez-Martínez, Lydia López Manzanares, Manuel de Jesús Díaz Pérez, Antonio Miñarro, Javier Ruiz‐Martínez, Jessica González Ardura, Berta Solano Vila, Cristina R. Fernández, Lydia Vela, Pilar Sánchez Alonso, Francisco Pérez Errazquin, Gema María Varó Sánchez, Carlos Leiva Santana, Daniel López Domínguez, Alejandro Rodríguez‐Molinero, Sonia Escalante Arroyo, Marta Montero, Maríateresa Buongiorno, María José Gómez Heredia, Alfredo López, Jorge Hernández‐Vara, Álvaro Sánchez‐Ferro, María A. Ávila Rivera, Ma Victoria Sánchez Peláez, Ioana Croitoru, Víctor Puente, R. García-Ramos, Emily Solano González, Rubén Alonso Redondo, Dolores Vilas, Silvia Martí Martínez, María Álvarez Saúco, Antonio Salvador Aliaga, Alexandre Gironell Carreró, Lourdes Ispierto González, Antonio Koukoulis Fernández, Juan Carlos Martínez‐Castrillo, José Juan, María Sierra Peña, Elisabet Franquet Gomez, Maria G. Alonso Losada, Pablo Mir, Antonio Guerrero, Luis Martín Garrido García, Rafael García Ruiz, Cristian Tebé, Marta Recio‐Bermejo, Esther Cubo, Irene Navalpotro Gómez, Àngels Bayes-Rusiñol
article en
2 citations

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).

npj Parkinson s DiseaseVol. 11(1)
Universidad de Cantabria (ES), Instituto de Salud Carlos III (ES), Hospital de Sant Pau (ES), Hospital Universitari Arnau de Vilanova (ES), University Hospital Complex Of Vigo (ES), Hospital Clínico San Carlos (ES), Biomedical Research Networking Center on Neurodegenerative Diseases (ES), Hospital Quirón Teknon (ES), Hospital Clínico Universitario de Valencia (ES), Marqués de Valdecilla University Hospital (ES), Hospital Universitario Fundación Alcorcón (ES), Hospital Universitario 12 De Octubre (ES), Universidad Europea (MX), Hospital Royo Villanova (ES), Vall d'Hebron Institut de Recerca (ES), Hospital Universitario Puerta de Hierro Majadahonda (ES), Hospital Regional Universitario de Málaga (ES), Instituto de Investigación Marqués de Valdecilla (ES), Centro de Investigación Biomédica en Red (ES), Hospital Universitario de Burgos (ES), Hospital General Universitario de Elche (ES), Hospital Arnau de Vilanova (ES), Hospital General de Catalunya (ES), Hospital San Juan de Dios (CL), Instituto Ramón y Cajal de Investigación Sanitaria (ES), Vall d'Hebron Hospital Universitari (ES), Mútua Terrassa (ES), Hospital Universitario de La Princesa (ES), Hospital Del Mar (ES), Hospital de Sant Joan Despí Moisès Broggi (ES), Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (ES), Hospital General Universitario de Alicante Doctor Balmis (ES), Donostiako Unibertsitate Ospitalea (ES), Hospital Universitario Lucus Augusti (ES), Hospital Universitari de Vic (ES), Hospital Universitari de Tortosa Verge de la Cinta (ES), Hospital Universitario Virgen del Rocío (ES), Hospital General de La Rioja (ES), Hospital Universitari Germans Trias i Pujol (ES), Hospital Universitari de Girona Doctor Josep Trueta (ES), Hospital Comarcal de Inca (ES), Hospital Clínico Universitario Virgen de la Victoria (ES), Consorci Sanitari Garraf (ES), Hospital Universitario Infanta Sofía (ES), Complejo Hospitalario Universitario de Toledo (ES), Hospital Universitario de Toledo (ES), Universitat de Barcelona (ES), Universidad de Sevilla (ES), Universidad Europea de Madrid (ES)
Instituto de Salud Carlos III
Openalex Percentile: Top 9%
Parkinson's Disease Mechanisms and Treatments
2.78
DOIOpen Access PDFOpenAlex
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