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

Study Overview
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Brief Summary
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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)

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Parkinson Holter
* Diagnostic Test: Motor fluctuations diary
* Other: Traditional clinical practice


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily time in Off | 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 | Number of patient visits and telephone controls to adjust medication | 6 months | 
| Patient's adherence to the MF measurement system | Total hour/days with information registered. | 7 days | 
| Number of therapeutic changes. | Number of therapeutic changes done to improve symptoms. | 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 | 6 months | 
| Daily time in On | Changes from baseline to last visit in daily hours in On | 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 | 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 | 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 | 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) | 7 days | 
| System usability: System Usability Scale | Usability of the system will be assessed by System Usability Scale (SUS) | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson, Motor fluctuation, Accelerometer, Parkinson diary