Parkinson’s disease medication adjustments based on wearable device information compared to other methods: randomized clinical trial
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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).
Source: npj Parkinson s Disease
Authors: Alejandro Rodríguez-Molinero, Carlos Pérez-López, Nuria Caballol, Mariateresa Buongiorno, María Asunción Ávila Rivera, Núria López Ariztegui, Lydia López-Manzanares, Jorge Hernández-Vara, Àngels Bayes-Rusiñol, Alexandre Gironell Carreró, María Álvarez Saúco, Elisabet Franquet Gomez, David A. Pérez-Martínez, Sonia Escalante Arroyo, Silvia Martí-Martínez, Pablo Mir, José Mª Salom Juan, Juan Carlos Martínez-Castrillo, Cristian Tebé, Anna Planas-Ballvé, Pau Pastor, Ignacio Alvarez, Mª Isabel Morales Casado, Sara Lucas del Pozo, Anna Prats, Álvaro Sánchez-Ferro, Antonio Méndez Guerrero, Carlos Leiva Santana, Laura Muñoz-Delgado, Daniel Macías-García, Silvia Jesús, Astrid Adarmes-Gómez, Antonio Salvador Aliaga, Gema Sánchez, Esther Cubo, Lourdes Ispierto González, Ramiro Álvarez-Ramo, Dolores Vilas Rolan, Antonio Koukoulis Fernández, Mª Gema Alonso Losada, Jon Infante, María Sierra Peña, Isabel González Aramburu, Mª Victoria Sánchez Peláez, Marina Mata Álvarez-Santullano, Carmen Borrúe Fernández, Mª Concepción Jimeno Montero, Lydia Vela Desojo, Berta Solano Vila, Anna Cots Foraster, Daniel López Domínguez, Esteban Peña Llamas, Pilar Sánchez Alonso, Elisa Gamo Gonzalez, Sabela Novo Ponte, Alfredo López López, Mª José Gómez Heredia, Francisco Pérez Errazquin, Mª Pilar Solís Pérez, Esther Blanco Vicente, Rafael García Ruiz, Ana Rita Santos Pinto, Marta Recio-Bermejo, Ernest Balaguer, Antonio Hernández Vidal, Rocío García-Ramos, Eva López Valdés, Rubén Alonso Redondo, Jessica González Ardura, Teresa Muñoz Ruiz, Lucía Flores García, Javier Ruiz Martínez, Ana Vinagre Aragón, Ioana Croitoru, Esther Catena Ruiz, Victor Puente, Irene Navalpotro Gómez, Antonio Miñarro
Institutions: Consorci Sanitari Garraf, Hospital de Sant Joan Despí Moisès Broggi, Vall d'Hebron Hospital Universitari, Hospital Universitario de Toledo, Hospital Universitario de La Princesa, Vall d'Hebron Institut de Recerca, Hospital Quirón Teknon, Hospital de Sant Pau, Hospital General Universitario de Elche, Hospital Universitario 12 De Octubre, Hospital Universitari de Tortosa Verge de la Cinta, Hospital General Universitario de Alicante Doctor Balmis, Instituto de Salud Carlos III, Biomedical Research Networking Center on Neurodegenerative Diseases, Centro de Investigación Biomédica en Red, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Hospital Clínico Universitario de Valencia, Instituto Ramón y Cajal de Investigación Sanitaria, Hospital Universitario Ramón y Cajal, Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, University Hospital Mútua de Terrassa, Mútua Terrassa, Hospital Universitario de Burgos, University Hospital Complex Of Vigo, Universidad de Cantabria, Marqués de Valdecilla University Hospital, Instituto de Investigación Marqués de Valdecilla, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Hospital Universitario Fundación Alcorcón, Hospital Universitari de Girona Doctor Josep Trueta, Hospital Universitario Sanitas La Moraleja, Hospital Universitario Puerta de Hierro Majadahonda, Hospital Royo Villanova, Hospital Clínico Universitario Virgen de la Victoria, Hospital Arnau de Vilanova, Hospital General de Catalunya, Hospital Clínico San Carlos, Hospital Universitario Lucus Augusti, Hospital Regional Universitario de Málaga, Donostiako Unibertsitate Ospitalea, Consortium for Health and Social Catalonia, Hospital Del Mar, Universitat de Barcelona
Language: English
Subfield: Clinical Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,890
Funder: Instituto de Salud Carlos III
OpenAlex ID: W4413355451