Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - 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)

Conditions

• Parkinson Disease

Interventions

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).

Sponsors & Collaborators

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• European Regional Development Fund

  collaborator OTHER

• Consorci Sanitari de l'Alt Penedès i Garraf

  lead OTHER

Principal Investigators

• Alejandro Rodríguez-Molinero, PhD/MD · Consorci Sanitari de l'Alt Penedès i Garraf

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-26

Primary Completion

2022-12-31

Completion

2023-06-21

Countries

• Spain

Study Locations