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 enrollmentJune 25, 2019

ConditionsParkinson's Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Parkinson's Disease
Sponsor: Takeda Pharmaceutical Company Limited
Enrollment: 100
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

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.

Registry

who.int

Start Date

June 25, 2019

End Date

December 22, 2021

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Takeda Pharmaceutical Company Limited

Eligibility Criteria

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.