JPRN-jRCT1080224748CompletedUnknown
An Observational Study for the Application of Wearable, Multi-Sensor Technology to Characterize Motor Function of Parkinson's Disease Patients in Japan
Takeda Pharmaceutical Company Limited0 sites100 target enrollmentStarted: June 25, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Enrollment
- 100
Study Overview
Brief Summary
se of the Verily Study Watch to monitor motor function in Parkinson's disease patients has the potential to assess disease progression and severity on a continual basis and thereby help guide clinicians towards more informed strategies to optimize patient management.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1.In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements, including adherence to Study Watch wearing, daily charging/syncing, submission of periodic patient-reported outcome measures, tagging medication ingestion on the Study Watch each day, and performing simple, standardized motor tasks.
- •2.The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
- •3.The participant has been diagnosed with Parkinson's disease for at least 5 years.
- •4.The participant is male or female and aged 20 years or older at the time of informed consent.
- •5.The participant is treated with oral levodopa with/without other medications.
- •6.The participant has clear-cut and robust response to levodopa, historically and presently, based on history and/or formal clinical off- and on-medication exam.
- •7.The participant is experiencing motor fluctuations, with at least one troubling motor off period each day (with/without dyskinesia).
- •8.The participant is scheduled for an at least 5-day hospitalization as part of routine clinical care for in-depth evaluation of motor function, with or without other therapeutic intervention.
Exclusion Criteria
- •1.The participant has nickel or metal jewelry allergy.
- •2.The participant has cognitive impairment that, in the opinion of the investigator, would interfere with the ability to report on symptoms and function.
- •3.The participant has another medical condition that would interfere with interpretation of parkinsonian motor symptoms (e.g., significant musculoskeletal disorder).
- •4.The participant has any risk that, in the opinion of the investigator, would harm his/her health with performing structured tasks at home.
- •5.The participant is judged by the investigator as being ineligible for any other reason.
Investigators
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