Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
Condition: Parkinson´s Disease
MeSH terms: Parkinson Disease
Intervention: Kinesia-ONE™; Kinesia-360™; Rotigotine
Intervention description: Kinesia-ONE™ wearable sensor uses a subject-worn finger sensor and iPad mini application (APP) to objectively measure specific motor tasks related to Parkinson's disease symptoms such as tremor, bradykinesia (slowed movements), and dyskinesia (involuntary movements) in the Investigator's office. Subjects should wear the Kinesia-ONE™ device on the most affected side.; Kinesia-360™ wearable sensor includes a wrist and ankle device, along with a cell phone, which is also APP-based, and is designed for continuous day time monitoring of Parkinson's disease symptoms. Subjects will wear Kinesia-360™ while they go about their daily lives, and symptom severity is continually captured to enable objective assessment of Parkinson's disease symptoms. Subjects should wear the Kinesia-360™ device bands on the most affected side.; All subjects will start Neupro treatment at a dose of either rotigotine 2 mg/24 h or 4 mg/24 h (according to the disease stage of the subject) which will then be adjusted based on symptom assessment either via standard care alone or via a combination of standard care and evaluation of the recordings made available by the Kinesia wearable technologies.
Intervention MeSH terms: Rotigotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parkinson´s Disease; Kinesia-360™; Kinesia-ONE™; Biosensor

Summary:

      Evaluate the benefits of Kinesia-360™ wearable technology in addition to standard clinical
      practice on improving Parkinson´s disease motor symptoms, Neupro dosing regimen and adherence
      to Neupro compared with only standard clinical practice.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is newly prescribed Neupro and is expected to commence Neupro treatment.
             Historical Neupro treatment is permitted

          -  Informed Consent form (ICF) is signed and dated by the subject, before any
             study-related procedures

          -  Subject is considered reliable and capable of adhering to the protocol, visit
             schedule, completion of the diary, and using Kinesia devices according to the judgment
             of the Investigator

          -  Male or female subject, >=18 years of age at the time of the Screening Visit

          -  Subject has Parkinson's disease, defined by the cardinal sign, bradykinesia, plus the
             presence of at least 1 of the following: tremor at rest, rigidity or impairment of
             postural reflexes, and without any other known or suspected cause of Secondary
             Parkinsonism

          -  Subject experiences motor symptoms associated with Parkinson's disease that are not
             sufficiently controlled by current therapy. The average of the triplicate resting
             tremor scores and triplicate finger tapping scores from Kinesia-ONE™ (6 scores in
             total) must be >1.0

        Exclusion Criteria:

          -  Subject is currently participating in any study with an investigational medicinal
             product or investigational device

          -  Subject has any medical, neurological or psychiatric condition which, in the opinion
             of the Investigator, could jeopardize or would compromise the subject's ability to
             participate in this study

          -  Subject with Deep Brain Stimulation (DBS) device implant