Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial

Parkinson Disease Clinical Trial

— MoMoPa-EC  

Official title:

Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04176302
• Other study ID #: INV_PROC_A118
• Secondary ID: DTS17/00195
• Status: Completed
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: June 21, 2023

Study information

• Verified date: April 2021
• Source: Consorci Sanitari de l'Alt Penedès i Garraf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: June 21, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Parkinson Holter
The neurologists will receive the wearable report (for medication adjustment, if any as per physician's criteria/judgement)

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:
• 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).

Locations

Country	Name	City	State
Spain	Hospital General La Mancha-Centro, Alcázar de San Juan	Alcázar De San Juan	Ciudad Real
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital General de Elche	Alicante
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Moisès Broggi - CS Integral	Barcelona
Spain	Hospital Sanitas CIMA	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Terapia Integral UParkinson, SL	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital Universitario de Donostia	Donostia	Guipúzkoa
Spain	Hospital Univesitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Universitari dr. Josep Trueta	Girona
Spain	Hospital General de l'Hospitalet. CS Integral	Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario Juan Ramón Jiménez	Huelva
Spain	Hospital Universitario Lucus Augustí	Lugo	Galicia
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario del Henares	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario La Moraleja	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro, Majadahonda	Majadahonda	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Consorci Sanitari del Maresme. Hospital de Mataró	Mataró	Barcelona
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 Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Consorci Sanitari de Terrassa	Terrassa
Spain	Hospital Universitari Mútua Terrassa	Terrassa	Barcelona
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hospital Verge de la Cinta	Tortosa	Tarragona
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital de Llíria	Valencia
Spain	Hospital Álvaro Cunqueiro	Vigo	Pontevedra
Spain	Consorci Sanitari de l'Alt Penedès i Garraf	Vilafranca Del Penedès	Barcelona
Spain	Hospital Royo de Vilanova	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf	European Regional Development Fund, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

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