Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial (MoMoPa-EC)

March 9, 2022 updated by: Consorci Sanitari de l'Alt Penedès i Garraf

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alejandro Rodríguez-Molinero, PhD/MD
  • Phone Number: 34-938940025
  • Email: arodriguez@csapg.cat

Study Locations

  • Spain
      • Alicante, Spain
        • Recruiting
        • Hospital General Universitario de Alicante
        • Principal Investigator:
          • Silvia Martí Martínez, PhD/MD
      • Alicante, Spain
        • Recruiting
        • Hospital General de Elche
        • Principal Investigator:
          • María Álvarez Saúco, PhD/MD
      • Badalona, Spain
        • Not yet recruiting
        • Hospital Universitari Germans Trias i Pujol
        • Principal Investigator:
          • Lourdes M Ispierto González, PhD/MD
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Jorge Hernández-Vara, PhD/MD
      • Barcelona, Spain
        • Recruiting
        • Hospital del Mar
        • Principal Investigator:
          • Víctor M Puente Periz, PhD/MD
      • Barcelona, Spain
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Principal Investigator:
          • Alexandre Gironell Carreró, PhD/MD
      • Barcelona, Spain
        • Recruiting
        • Hospital Moisès Broggi - CS Integral
        • Principal Investigator:
          • Nuria Caballol Pons, PhD/MD
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Sanitas Cima
        • Principal Investigator:
          • Pilar M Quilez Ferrer, PhD/MD
      • Barcelona, Spain
        • Recruiting
        • Terapia Integral UParkinson, SL
        • Principal Investigator:
          • Angels M Bayés Rusiñol, PhD/MD
      • Burgos, Spain
        • Recruiting
        • Hospital Universitario De Burgos
        • Principal Investigator:
          • Esther M Cubo Delgado, PhD/MD
      • Girona, Spain
        • Not yet recruiting
        • Hospital Universitari Dr. Josep Trueta
        • Principal Investigator:
          • Berta M Solano Vila, PhD/MD
      • Huelva, Spain
        • Not yet recruiting
        • Hospital Universitario Juan Ramon Jimenez
        • Principal Investigator:
          • Juan Manuel Oropesa Ruiz, PhD/MD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • David A Pérez-Martínez, PhD/MD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Principal Investigator:
          • Juan Carlos Martínez-Castrillo, PhD/MD
      • Madrid, Spain
        • Recruiting
        • Hospital Clinico San Carlos
        • Principal Investigator:
          • Rocío García Ramos, PhD/MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario La Princesa
        • Principal Investigator:
          • Lydia M López Manzanares, PhD/MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Fundación Jiménez Díaz
        • Principal Investigator:
          • Pedro J. García Ruíz Espiga, PhD/MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario del Henares
        • Principal Investigator:
          • Elvira García Cobos, PhD/MD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Moraleja
        • Principal Investigator:
          • Esteban M Peña Llamas, PhD/MD
      • Málaga, Spain
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Principal Investigator:
          • Mª José Gómez Heredia, PhD/MD
      • Málaga, Spain
        • Recruiting
        • Hospital Regional Universitario de Malaga
        • Principal Investigator:
          • Teresa Muñoz Ruiz, PhD/MD
      • San Sebastián De Los Reyes, Spain
        • Recruiting
        • Hospital Universitario Infanta Sofía
        • Principal Investigator:
          • Marina M Mata Álvarez-Santullano, PhD/MD
      • Sant Boi De Llobregat, Spain
        • Not yet recruiting
        • Hospital General Parc Sanitari Sant Joan de Déu
        • Principal Investigator:
          • Antoni M Callén Soto, Phd/MD
      • Sant Cugat Del Vallès, Spain
        • Not yet recruiting
        • Hospital Universitari General de Catalunya
        • Principal Investigator:
          • Ernest M Balaguer Martínez, PhD/MD
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Pablo Mir Rivera, PhD/MD
      • Terrassa, Spain
        • Not yet recruiting
        • Consorci Sanitari de Terrassa
        • Principal Investigator:
          • Gabriel M Salazar Tortolero, PhD/MD
      • Toledo, Spain
        • Recruiting
        • Hospital Virgen de la Salud
        • Principal Investigator:
          • Núria López Ariztegui, PhD/MD
      • Valencia, Spain
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Principal Investigator:
          • José María Salom, PhD/MD
      • Valencia, Spain
        • Recruiting
        • Hospital de Llíria
        • Principal Investigator:
          • Mª Pilar Solís Pérez, PhD/MD
      • Zaragoza, Spain
        • Recruiting
        • Hospital Royo de Vilanova
        • Principal Investigator:
          • Alfredo López López, PhD/MD
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain
        • Recruiting
        • Hospital General de l'Hospitalet. CS Integral
        • Principal Investigator:
          • Asunción Ávila, PhD/MD
      • Mataró, Barcelona, Spain
        • Not yet recruiting
        • Consorci Sanitari del Maresme. Hospital de Mataró
        • Principal Investigator:
          • Pilar M Sanz Cartagena, PhD/MD
      • Terrassa, Barcelona, Spain
        • Recruiting
        • Hospital Universitari Mutua Terrassa
        • Principal Investigator:
          • Pau Pastor, PhD/MD
        • Principal Investigator:
          • Maria Teresa Buongiorno, PhD/MD
      • Vilafranca Del Penedès, Barcelona, Spain
        • Recruiting
        • Consorci Sanitari de l'Alt Penedès i Garraf
        • Principal Investigator:
          • Alfons Moral, PhD/MD
    • Cantabria
      • Santander, Cantabria, Spain
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Principal Investigator:
          • Jon Infante Ceberio, PhD/MD
    • Ciudad Real
      • Alcázar De San Juan, Ciudad Real, Spain
        • Recruiting
        • Hospital General La Mancha-Centro, Alcázar de San Juan
        • Principal Investigator:
          • Marta Recio Bermejo, PhD/MD
    • Galicia
      • Lugo, Galicia, Spain
        • Recruiting
        • Hospital Universitario Lucus Augusti
        • Principal Investigator:
          • Jessica González Ardura, PhD/MD
    • Guipúzkoa
      • Donostia, Guipúzkoa, Spain
        • Not yet recruiting
        • Hospital Universitario de Donostia
        • Principal Investigator:
          • Javier Ruíz Martínez, PhD/MD
    • Madrid
      • Alcorcón, Madrid, Spain
        • Recruiting
        • Hospital Universitario Fundacion Alcorcon
        • Principal Investigator:
          • Lydia M Vela Desojo, PhD/MD
      • Majadahonda, Madrid, Spain
        • Recruiting
        • Hospital Universitario Puerta de Hierro, Majadahonda
        • Principal Investigator:
          • Pilar Sánchez Alonso, PhD/MD
    • Murcia
      • El Palmar, Murcia, Spain
        • Not yet recruiting
        • Hospital Univesitario Virgen de la Arrixaca
        • Principal Investigator:
          • José María López, PhD/MD
    • Pontevedra
      • Vigo, Pontevedra, Spain
        • Recruiting
        • Hospital Álvaro Cunqueiro
        • Principal Investigator:
          • Antonio Kouloulis Fernández, PhD/MD
    • Tarragona
      • Tortosa, Tarragona, Spain
        • Recruiting
        • Hospital Verge de la Cinta
        • Principal Investigator:
          • Sonia M Escalante Arroyo, PhD/MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Parkinson Holter
The neurologists in the study will receive information from the Parkinson Holter (device being studied)
Device: Parkinson Holter
The neurologists will receive the wearable report (for medication adjustment, if any as per physician's criteria/judgement)
Other Names:
  • STAT-ON ® sensor
Active Comparator: Parkinson's diary
The neurologists in the study will receive information from a motor fluctuations diary
Diagnostic test: Motor fluctuations diary
The neurologists will receive the patient's diary report (for medication adjustment, if any as per physician's criteria/judgement).
Other Names:
  • Parkinson's diary
Placebo Comparator: Traditional clinical practice
The neurologists in the study will receive no additional information other than what is obtained during the visit
Other: 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 Names:
  • Clinical interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily time in Off
Time Frame: 7 days
Changes from baseline to last visit in daily hours in Off
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of clinical contacts
Time Frame: 6 months
Number of patient visits and telephone controls to adjust medication
6 months
Patient's adherence to the MF measurement system
Time Frame: 7 days
Total hour/days with information registered.
7 days
Number of therapeutic changes.
Time Frame: 6 months
Number of therapeutic changes done to improve symptoms.
6 months
Motor complications
Time Frame: 6 months
Changes from baseline to last visit in motor complications, assessed by means of Unified Parkinson's Disease Rating Scale - part IV
6 months
Daily time in On
Time Frame: 7 days
Changes from baseline to last visit in daily hours in On
7 days
Change of presence and severity of freezing of gait episodes
Time Frame: 7 days
Changes from baseline to last visit in the number and severity of freezing of gait episodes, assessed by means of Freezing of Gait Questionnaire
7 days
Reported quality of life
Time Frame: 1 month
Changes from baseline to last visit in quality of life, assessed by menas of Parkinson's Disease Questionnaire-39
1 month
Activities of Daily Living
Time Frame: 6 months
Changes from baseline to last visit in dependence for Activities of Daily Living assessed by means of Unified Parkinson's Disease Rating Scale - part II
6 months
User satisfaction: Quebec User Evaluation of Satisfaction with assistive Technology
Time Frame: 7 days
Physician and patient satisfaction with the Parkinson Holter will be assessed by means of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
7 days
System usability: System Usability Scale
Time Frame: 7 days
Usability of the system will be assessed by System Usability Scale (SUS)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Collaborators

Instituto de Salud Carlos III
European Regional Development Fund

Investigators

  • Study Director: Alejandro Rodríguez-Molinero, PhD/MD, Consorci Sanitari de l'Alt Penedès i Garraf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2019

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INV_PROC_A118
  • DTS17/00195 (Other Grant/Funding Number: Instituto de Salud Carlos III - European Regional Development Fund (ERDF))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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