Parkinson DiseaseMoMoPa-ECNCT04176302
Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial
A study testing Parkinson Holter, Motor fluctuations diary and Traditional clinical practice in people with Parkinson Disease, run by Consorci Sanitari de l'Alt Penedès i Garraf at 43 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Parkinson Holter, Motor fluctuations diary and Traditional clinical practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 43 sitesSpain
- Study dates
- 26 Nov 2019to 21 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
Spain43 sites
Hospital General La Mancha-Centro, Alcázar de San Juan
Alcázar de San Juan, Ciudad Real
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid
Hospital General de Elche
Alicante
Hospital General Universitario de Alicante
Alicante
Hospital Universitari Germans Trias i Pujol
Badalona
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona
Hospital del Mar
Barcelona, Barcelona
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona
Hospital Moisès Broggi - CS Integral
Barcelona
Hospital Sanitas CIMA
Barcelona
Terapia Integral UParkinson, SL
Barcelona
Hospital Universitario de Burgos
Burgos
Hospital Universitario de Donostia
Donostia / San Sebastian, Guipúzkoa
Hospital Univesitario Virgen de la Arrixaca
El Palmar, Murcia
Hospital Universitari dr. Josep Trueta
Girona
Hospital Universitario Juan Ramón Jiménez
Huelva
Hospital General de l'Hospitalet. CS Integral
L'Hospitalet de Llobregat, Barcelona
Hospital Universitario Lucus Augustí
Lugo, Galicia
Hospital Universitario 12 de Octubre
Madrid, Madrid
Hospital Universitario del Henares
Madrid, Madrid
Hospital Universitario La Princesa
Madrid, Madrid
Hospital Universitario Ramón y Cajal
Madrid, Madrid
Hospital Clínico San Carlos
Madrid
Hospital Universitario Fundación Jiménez Díaz
Madrid
Hospital Universitario La Moraleja
Madrid
Hospital Universitario Puerta de Hierro, Majadahonda
Majadahonda, Madrid
Hospital Regional Universitario de Málaga
Málaga
Hospital Universitario Virgen de la Victoria
Málaga
Consorci Sanitari del Maresme. Hospital de Mataró
Mataró, Barcelona
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes
Hospital General Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat
Hospital Universitari General de Catalunya
Sant Cugat del Vallès
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria
Hospital Universitario Virgen del Rocío
Seville
Hospital Universitari Mútua Terrassa
Terrassa, Barcelona
Consorci Sanitari de Terrassa
Terrassa
Hospital Virgen de la Salud
Toledo
Hospital Verge de la Cinta
Tortosa, Tarragona
Hospital Clínico Universitario de Valencia
Valencia
Hospital de Llíria
Valencia
Hospital Álvaro Cunqueiro
Vigo, Pontevedra
Consorci Sanitari de l'Alt Penedès i Garraf
Vilafranca del Penedès, Barcelona
Hospital Royo de Vilanova
Zaragoza
About this study
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)
- Conditions
- Parkinson Disease
- Being tested
- Parkinson Holter, Motor fluctuations diary, Traditional clinical practice
- Keywords
- Motor fluctuation, Parkinson, Accelerometer, Parkinson diary
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parkinson HolterDevice
Also called STAT-ON ® sensor
The neurologists will receive the wearable report (for medication adjustment, if any as per physician's criteria/judgement)
Motor fluctuations diaryDiagnostic test
Also called Parkinson's diary
The neurologists will receive the patient's diary report (for medication adjustment, if any as per physician's criteria/judgement).
Traditional clinical practiceOther
Also called Clinical interview
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).
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Holter | Active comparator | The neurologists in the study will receive information from the Parkinson Holter (device being studied) Receives: Device: Parkinson Holter |
| Parkinson's diary | Active comparator | The neurologists in the study will receive information from a motor fluctuations diary Receives: Diagnostic Test: Motor fluctuations diary |
| Traditional clinical practice | Placebo comparator | The neurologists in the study will receive no additional information other than what is obtained during the visit Receives: Other: Traditional clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily time in Off
Changes from baseline to last visit in daily hours in Off
Measured: 7 days
Secondary outcomes (10)
Number of clinical contacts
Number of patient visits and telephone controls to adjust medication
Measured: 6 months
Patient's adherence to the MF measurement system
Total hour/days with information registered.
Measured: 7 days
Number of therapeutic changes.
Number of therapeutic changes done to improve symptoms.
Measured: 6 months
Motor complications
Changes from baseline to last visit in motor complications, assessed by means of Unified Parkinson's Disease Rating Scale - part IV
Measured: 6 months
Daily time in On
Changes from baseline to last visit in daily hours in On
Measured: 7 days
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
Measured: 7 days
Reported quality of life
Changes from baseline to last visit in quality of life, assessed by menas of Parkinson's Disease Questionnaire-39
Measured: 1 month
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
Measured: 6 months
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)
Measured: 7 days
System usability: System Usability Scale
Usability of the system will be assessed by System Usability Scale (SUS)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start26 Nov 2019
- Primary completion31 Dec 2022
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, European Regional Development Fund
- Responsible party
- Sponsor
- Investigators
- Alejandro Rodríguez-Molinero, PhD/MD, Study director, Consorci Sanitari de l'Alt Penedès i Garraf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176302
- Sponsor's protocol ID
- INV_PROC_A118
- Other IDs
- DTS17/00195
- Acronym
- MoMoPa-EC
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2019
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40835832Perez-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.
PubMed 35651347Rodriguez-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.
PubMed 34281918
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial
- ClinicalTrials.gov ID
- NCT04176302
- Acronym / sponsor ID
- MoMoPa-EC / INV_PROC_A118
- Conditions
- Parkinson Disease
- Keywords
- Motor fluctuation, Parkinson, Accelerometer, Parkinson diary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, European Regional Development Fund
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson Holter | Active comparator | Device: Parkinson HolterThe neurologists in the study will receive information from the Parkinson Holter (device being studied) |
| Parkinson's diary | Active comparator | Diagnostic Test: Motor fluctuations diaryThe neurologists in the study will receive information from a motor fluctuations diary |
| Traditional clinical practice | Placebo comparator | Other: Traditional clinical practiceThe neurologists in the study will receive no additional information other than what is obtained during the visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parkinson HolterAlso: STAT-ON ® sensorThe neurologists will receive the wearable report (for medication adjustment, if any as per physician's criteria/judgement) | Device | Parkinson Holter |
| Motor fluctuations diaryAlso: Parkinson's diaryThe neurologists will receive the patient's diary report (for medication adjustment, if any as per physician's criteria/judgement). | Diagnostic test | Parkinson's diary |
| Traditional clinical practiceAlso: Clinical interviewThe 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 | Traditional clinical practice |
Primary outcome
Daily time in Off
Time frame: 7 days
Changes from baseline to last visit in daily hours in Off
10 secondary outcomes
Number of clinical contacts
Time frame: 6 months
Patient's adherence to the MF measurement system
Time frame: 7 days
Number of therapeutic changes.
Time frame: 6 months
Motor complications
Time frame: 6 months
Daily time in On
Time frame: 7 days
Change of presence and severity of freezing of gait episodes
Time frame: 7 days
Reported quality of life
Time frame: 1 month
Activities of Daily Living
Time frame: 6 months
User satisfaction: Quebec User Evaluation of Satisfaction with assistive Technology
Time frame: 7 days
System usability: System Usability Scale
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Results publication: PubMed 40835832Rodriguez-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.
- Derived from this study: PubMed 35651347Perez-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.
- Derived from this study: PubMed 34281918Rodriguez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Rodríguez-Molinero, PhD/MD study director
Consorci Sanitari de l'Alt Penedès i Garraf
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parkinson Holter, Motor fluctuations diary and Traditional clinical practice in people with Parkinson Disease, run by Consorci Sanitari de l'Alt Penedès i Garraf at 43 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily time in Off (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04176302, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.