Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status

Condition(s) studied

Investigational drug(s) / intervention(s)

Personal KinetiGraph™ (PKG™): The Personal KinetiGraph™ (PKG™) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by Global Kinetics (GKC). The Personal KinetiGraph™ (PKG™) Movement Recording System consists of the following: * A wrist-worn data logger designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. * An application to configure the data logger and transfer the acquired data at the end of a recording. * A series of algorithms that analyze the uploaded data, producing a report that is delivered to the clinician. The report contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility.

Study summary

The primary objective is to understand the utility of Personal KinetiGraph movement recording system data in the clinical management of Parkinson's disease (PD) in routine clinical care at a movement disorders clinic. Specifically:

1. Measure medication use and clinical management plan changes in a large, multicenter cohort among participants undergoing a clinical assessment with an MDS in which the MDS reviews the participant's PKG during the clinical assessment in half of the enrolled participants (PKG + Group) and in half of the enrolled participants the MDS completes the clinical assessment without the PKG (PKG- Group).
2. Determine the association between frequency of medication changes, the PKG information, and other clinical assessments among participants with and without a PKG report of their PD motor status available to the clinician at the time of evaluation.

Eligibility

Primary outcome measure(s)

• Evaluation of treatment changes with or without the use of PKG data — 90 day
  The proportion of patients in which the clinical management plan was changed in patients followed in the PKG- Group (clinician standard of care) compared to the PKG+ Group (clinician standard of care with the use of PKG data).

Trial sites (12)

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