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

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ClinicalTrials.gov Identifier: NCT04176302
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : August 24, 2021
Sponsor:
Collaborators:
Instituto de Salud Carlos III
European Regional Development Fund
Information provided by (Responsible Party):
Consorci Sanitari de l'Alt Penedès i Garraf

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)


Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Parkinson Holter Diagnostic Test: Motor fluctuations diary Other: Traditional clinical practice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial
Actual Study Start Date : November 26, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Clinical interview




Primary Outcome Measures :
  1. Daily time in Off [ Time Frame: 7 days ]
    Changes from baseline to last visit in daily hours in Off


Secondary Outcome Measures :
  1. Number of clinical contacts [ Time Frame: 6 months ]
    Number of patient visits and telephone controls to adjust medication

  2. Patient's adherence to the MF measurement system [ Time Frame: 7 days ]
    Total hour/days with information registered.

  3. Number of therapeutic changes. [ Time Frame: 6 months ]
    Number of therapeutic changes done to improve symptoms.

  4. 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

  5. Daily time in On [ Time Frame: 7 days ]
    Changes from baseline to last visit in daily hours in On

  6. 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. 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

  8. 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

  9. 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)

  10. System usability: System Usability Scale [ Time Frame: 7 days ]
    Usability of the system will be assessed by System Usability Scale (SUS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176302


Contacts
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Contact: Alejandro Rodríguez-Molinero, PhD/MD 34-938940025 arodriguez@csapg.cat

Locations
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Sponsors and Collaborators
Consorci Sanitari de l'Alt Penedès i Garraf
Instituto de Salud Carlos III
European Regional Development Fund
Investigators
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Study Director: Alejandro Rodríguez-Molinero, PhD/MD Consorci Sanitari de l'Alt Penedès i Garraf
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Consorci Sanitari de l'Alt Penedès i Garraf
ClinicalTrials.gov Identifier: NCT04176302    
Other Study ID Numbers: INV_PROC_A118
DTS17/00195 ( Other Grant/Funding Number: Instituto de Salud Carlos III - European Regional Development Fund (ERDF) )
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Consorci Sanitari de l'Alt Penedès i Garraf:
Motor fluctuation
Parkinson
Accelerometer
Parkinson diary
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases