Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
Parkinson´s Disease
About this trial
This is an interventional treatment trial for Parkinson´s Disease focused on measuring Parkinson´s Disease, Kinesia-360™, Kinesia-ONE™, Biosensor
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
Sites / Locations
- Pd0049 105
- Pd0049 102
- Pd0049 108
- Pd0049 103
- Pd0049 106
- Pd0049 104
- Pd0049 107
- Pd0049 109
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Rotigotine + Standard Care
Rotigotine + Standard Care + Kinesia-360™ wearable device
Subjects will use the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject will be determined by standard clinical practice.
Subjects will use the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects will use the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator will use these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject.