Objective: To understand the validity of wearable devices in capturing objective motor and nonmotor symptoms of Parkinson’s Disease (PD) in addition to what has been captured by the rating scales in a clinical trial.

Background: Clinician Reported Outcomes (ClinRO) and patient reported outcomes (PRO) are standardly used in PD trials to assess the primary objective of the trial. However, PRO’s such as subject diaries are often completed outside of the prescribed timelines. Thus, there is value in obtaining continuous objective data in a real-time manner to support primary study objectives through capture of motor and non-motor symptoms, beyond the duration of a clinical visit.

Method: 110 subjects enrolled into an idiopathic PD study were given a wearable device that would assess bradykinesia, tremor, general activity, and sleep at baseline, Visit 5 and Visit 6. Subjects were verbally instructed how to use the device and were sent home to wear the device for 7 days prior to each of the 3 visits. The devices were returned to the office at the next scheduled study visit, at which time the site downloaded the data to the vendor’s database. There was no real-time reporting to capture whether subjects wore the device for a minimum of 70% of the day, at least 4 of the 7 assigned days, which would result in a valid recording.

Results: Usage data was received for 324 study visits, which is 98% of the expected data. The received data includes subjects who early terminated as well as those who wore the device more than three weeks. The device was to be worn for 7 days, and as assessed at least 4 days of recording will provide reliable measures. Overall 5% of subject visit data were deemed not valid because the subject didn’t wear the watch at least 4 out of 7 days.

Conclusion: The use of wearable devices to provide objective insights into daily activities is a valid tool to assess PD motor and non-motor symptoms. The value of the data received correlates with how closely the wearer follows the guidance in the protocol. When using a wearable or digital device, alerts should be implemented to remind the subject to use the device, and to alert site staff or the study team when the device isn’t being used as instructed. Written instruction and ‘live’ visibility are critical as events are occurring to improve reliability of the data. Ranges for “valid data” should be established prospectively.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/wearable-devices-in-movement-disorder-trials-to-provide-objective-measures/