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

Consorci Sanitari de l'Alt Penedès i Garraf

Status: Completed

Conditions: Parkinson Disease

Treatments: Diagnostic Test: Motor fluctuations diary; Device: Parkinson Holter; Other: Traditional clinical practice

Study type: Interventional

Funder types: Other

Identifiers

NCT04176302

DTS17/00195 (Other Grant/Funding Number)

INV_PROC_A118

Details and patient eligibility

About

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)

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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173 participants in 3 patient groups, including a placebo group

Parkinson Holter

Active Comparator group

Description:

The neurologists in the study will receive information from the Parkinson Holter (device being studied)

Treatment:

Device: Parkinson Holter

Parkinson's diary

Active Comparator group

Description:

The neurologists in the study will receive information from a motor fluctuations diary

Treatment:

Diagnostic Test: Motor fluctuations diary

Traditional clinical practice

Placebo Comparator group

Description:

The neurologists in the study will receive no additional information other than what is obtained during the visit

Treatment:

Other: Traditional clinical practice