Clinical trial NCT04176302: Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial
Official title: Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Motor fluctuation
Parkinson
Accelerometer
Parkinson diary
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: European Regional Development Fund
First posted: 2019-11-25
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: When Parkinson Disease is mild, it responds well to treatment with drugs (L-Dopa and dopamine antagonists). However, as the disease progresses, the effect of the drugs diminishes and lasts for a shorter time (wearing-off), which require physicians to progressively increase and/or break up the dosage of dopamine drugs, to control symptoms over the course of the entire day. Despite this, most patients present motor fluctuations after 10 years. These fluctuations consist of changes between what are known as Off periods, when the medication does not produce an effect and mobility is hindered, and On periods when patients can move smoothly, with the medication producing its best effect.

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)


Eligibility criteria: Inclusion Criteria:

* Ideopathic Parkinson's Disease
* 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:

* Incapable of walking independently or H\&Y=5
* Participating in another clinical trial
* Patients with acute intercurrent disease
* Psychiatric or cognitive disorders that prevent collaboration (MMSE \<24)

Primary outcomes:
measure: Daily time in Off
timeFrame: 7 days
Secondary outcomes:
measure: Number of clinical contacts
timeFrame: 6 months
measure: Patient's adherence to the MF measurement system
timeFrame: 7 days
measure: Number of therapeutic changes.
timeFrame: 6 months
measure: Motor complications
timeFrame: 6 months
measure: Daily time in On
timeFrame: 7 days
measure: Change of presence and severity of freezing of gait episodes
timeFrame: 7 days
measure: Reported quality of life
timeFrame: 1 month
measure: Activities of Daily Living
timeFrame: 6 months
measure: User satisfaction: Quebec User Evaluation of Satisfaction with assistive Technology
timeFrame: 7 days
measure: System usability: System Usability Scale
timeFrame: 7 days
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital General de l'Hospitalet. CS Integral
state: Barcelona
city: Mataró
country: Spain
facility: Consorci Sanitari del Maresme. Hospital de Mataró
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua Terrassa
state: Barcelona
city: Vilafranca Del Penedès
country: Spain
facility: Consorci Sanitari de l'Alt Penedès i Garraf
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Alcázar De San Juan
country: Spain
facility: Hospital General La Mancha-Centro, Alcázar de San Juan
state: Ciudad Real
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augustí
state: Galicia
city: Donostia
country: Spain
facility: Hospital Universitario de Donostia
state: Guipúzkoa
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro, Majadahonda
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Univesitario Virgen de la Arrixaca
state: Murcia
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Pontevedra
city: Tortosa
country: Spain
facility: Hospital Verge de la Cinta
state: Tarragona
city: Alicante
country: Spain
facility: Hospital General de Elche
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Moisès Broggi - CS Integral
city: Barcelona
country: Spain
facility: Hospital Sanitas CIMA
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Terapia Integral UParkinson, SL
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Girona
country: Spain
facility: Hospital Universitari dr. Josep Trueta
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramón Jiménez
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario del Henares
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario La Moraleja
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: San Sebastián De Los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofía
city: Sant Boi De Llobregat
country: Spain
facility: Hospital General Parc Sanitari Sant Joan de Déu
city: Sant Cugat Del Vallès
country: Spain
facility: Hospital Universitari General de Catalunya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital de Llíria
city: Zaragoza
country: Spain
facility: Hospital Royo de Vilanova
Study officials:
affiliation: Consorci Sanitari de l'Alt Penedès i Garraf
name: Alejandro Rodríguez-Molinero, PhD/MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.