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