Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial
NCT ID: NCT04176302
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
173 participants
INTERVENTIONAL
2019-11-26
2023-06-21
Brief Summary
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The timeline of these motor fluctuations over the course of the day and also on different days is very valuable to precisely adjust the medication. Nevertheless, neurologists do not currently have detailed information on the timeline of the symptoms of their patients, which means that they have serious difficulties to obtain good results with the adjustment of medication. Currently, the neurologist's information on the time progression of the motor fluctuations is drawn from what the patient indicates in the office visit, or in the best case, from diaries that the patient fills out at home, periodically (e.g. every hour) noting the motor state (On or Off). Although the latter method is still the gold standard in research and in care, it has serious limitations, because patients often forget to record the information (especially when they are in Off), many do not recognize their motor states well, and few can maintain adherence to such a laborious system for more than a few days.
The Parkinson Holter (STAT-ON ®) is a wearable device, which objectively measures and records the motor fluctuations of the patients. It does not require intervention by the patient, and can, therefore, be used in daily life, long term if necessary. However, the concept that detailed knowledge of motor fluctuations of patients will lead to better control of the disease, thanks to optimisation of the therapeutic regimen, is still a hypothesis. To demonstrate or refute this hypothesis, we are now conducting a clinical trial, with this medical device, to study the clinical effectiveness in patients with moderate Parkinson's disease and motor fluctuations. This trial will show whether using the Parkinson Holter is better than the clinical interview used in traditional clinical practice (primary objective), and whether it is not inferior to the On-Off diary recorded by the patients at home (exploratory objective)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Parkinson Holter
The neurologists in the study will receive information from the Parkinson Holter (device being studied)
Parkinson Holter
The neurologists will receive the wearable report (for medication adjustment, if any as per physician's criteria/judgement)
Parkinson's diary
The neurologists in the study will receive information from a motor fluctuations diary
Motor fluctuations diary
The neurologists will receive the patient's diary report (for medication adjustment, if any as per physician's criteria/judgement).
Traditional clinical practice
The neurologists in the study will receive no additional information other than what is obtained during the visit
Traditional clinical practice
The neurologists will receive the patient \& caregiver report at the time of the visit (for medication adjustment, if any as per physician's criteria/judgement).
Interventions
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Parkinson Holter
The neurologists will receive the wearable report (for medication adjustment, if any as per physician's criteria/judgement)
Motor fluctuations diary
The neurologists will receive the patient's diary report (for medication adjustment, if any as per physician's criteria/judgement).
Traditional clinical practice
The neurologists will receive the patient \& caregiver report at the time of the visit (for medication adjustment, if any as per physician's criteria/judgement).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease in the moderate-severe phase (Hoehn \& Yahr ≥ 2 en Off)
* Motor fluctuations (with at least 2h/day in Off)
* Agree to participate voluntarily and will sign a written consent form
Exclusion Criteria
* Participating in another clinical trial
* Patients with acute intercurrent disease
* Psychiatric or cognitive disorders that prevent collaboration (MMSE \<24)
18 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
European Regional Development Fund
OTHER
Consorci Sanitari de l'Alt Penedès i Garraf
OTHER
Responsible Party
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Principal Investigators
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Alejandro Rodríguez-Molinero, PhD/MD
Role: STUDY_DIRECTOR
Consorci Sanitari de l'Alt Penedès i Garraf
Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital General de l'Hospitalet. CS Integral
L'Hospitalet de Llobregat, Barcelona, Spain
Consorci Sanitari del Maresme. Hospital de Mataró
Mataró, Barcelona, Spain
Hospital Universitari Mútua Terrassa
Terrassa, Barcelona, Spain
Consorci Sanitari de l'Alt Penedès i Garraf
Vilafranca del Penedès, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital General La Mancha-Centro, Alcázar de San Juan
Alcázar de San Juan, Ciudad Real, Spain
Hospital Universitario Lucus Augustí
Lugo, Galicia, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Guipúzkoa, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitario del Henares
Madrid, Madrid, Spain
Hospital Universitario La Princesa
Madrid, Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro, Majadahonda
Majadahonda, Madrid, Spain
Hospital Univesitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Verge de la Cinta
Tortosa, Tarragona, Spain
Hospital General de Elche
Alicante, , Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Hospital Moisès Broggi - CS Integral
Barcelona, , Spain
Hospital Sanitas CIMA
Barcelona, , Spain
Terapia Integral UParkinson, SL
Barcelona, , Spain
Hospital Universitario de Burgos
Burgos, , Spain
Hospital Universitari dr. Josep Trueta
Girona, , Spain
Hospital Universitario Juan Ramón Jiménez
Huelva, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario La Moraleja
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, , Spain
Hospital General Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, , Spain
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Consorci Sanitari de Terrassa
Terrassa, , Spain
Hospital Virgen de la Salud
Toledo, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital de Llíria
Valencia, , Spain
Hospital Royo de Vilanova
Zaragoza, , Spain
Countries
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References
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Rodriguez-Molinero A, Perez-Lopez C, Caballol N, Buongiorno M, Avila Rivera MA, Lopez Ariztegui N, Lopez-Manzanares L, Hernandez-Vara J, Bayes-Rusinol A, Gironell Carrero A, Alvarez Sauco M, Franquet Gomez E, Perez-Martinez DA, Escalante Arroyo S, Marti-Martinez S, Mir P, Salom Juan JM, Martinez-Castrillo JC, Tebe C; MoMoPa-EC Research Group. Parkinson's disease medication adjustments based on wearable device information compared to other methods: randomized clinical trial. NPJ Parkinsons Dis. 2025 Aug 20;11(1):249. doi: 10.1038/s41531-025-00977-2.
Perez-Lopez C, Hernandez-Vara J, Caballol N, Bayes A, Buongiorno M, Lopez-Ariztegui N, Gironell A, Lopez-Sanchez J, Martinez-Castrillo JC, Sauco M A, Lopez-Manzanares L, Escalante-Arroyo S, Perez-Martinez DA, Rodriguez-Molinero A; MoMoPa-EC Research Group. Comparison of the Results of a Parkinson's Holter Monitor With Patient Diaries, in Real Conditions of Use: A Sub-analysis of the MoMoPa-EC Clinical Trial. Front Neurol. 2022 May 16;13:835249. doi: 10.3389/fneur.2022.835249. eCollection 2022.
Rodriguez-Molinero A, Hernandez-Vara J, Minarro A, Perez-Lopez C, Bayes-Rusinol A, Martinez-Castrillo JC, Perez-Martinez DA; Monitoring Parkinson's patients Mobility for therapeutic purposes research group. Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods: study protocol. BMJ Open. 2021 Jul 19;11(7):e045272. doi: 10.1136/bmjopen-2020-045272.
Other Identifiers
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DTS17/00195
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
INV_PROC_A118
Identifier Type: -
Identifier Source: org_study_id
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