Are you interested in using the PKG in your clinical trial?
Clinical Trial Services
Developed by Global Kinetics Pty Ltd, the PKG® is an innovative digital health technology. The PKG system provides a continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson’s disease including bradykinesia, dyskinesia and tremor. The PKG also provides an assessment of daytime somnolence.
The PKG system includes a wrist-worn movement recording device called the PKG Watch, proprietary algorithms and a data-driven report known as the PKG.
Data is collected continuously by the PKG Watch during activities of daily living in the home environment and can be programmed to remind the patient, at their prescribed Parkinson’s disease medication times, to register that they’ve taken their Parkinson’s disease medication. The PKG Watch should be worn by the patient for 7 days.
At the end of the recording period, the data is uploaded for processing. The PKG is generated and is provided to the patient’s clinician, graphically and numerically depicting the movement of the patient. The PKG shows scores representative of bradykinesia and dyskinesia, compared to healthy controls, throughout the day and from day to day. Other information such as medication compliance, motor fluctuations, immobility, tremor and periods where the PKG Watch was not worn are also shown.
The PKG system has received regulatory clearance through FDA 510 (k) in the USA, CE mark in Europe and is TGA Class IIa ARTG 236583 listed in Australia.
Indications for Use
The Personal Kinetigraph (PKG) System is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson’s disease, including tremor, bradykinesia and dyskinesia. It includes a medication reminder, an event marker and is intended to monitor activity associated with movement during sleep. The device is indicated for use in individuals 46 to 83 years of age.
6.2 Australia / EU
The PKG System is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson’s disease, including Bradykinesia and Dyskinesia. It has event markers for medication reminders and patient acknowledgement. The system may also be used to monitor activity associated with movement during sleep.
Use in Clinical Trials
The PKG® system is a clinically validated system for objective, ambulatory and continuous assessment of movement disorder symptoms in Parkinson’s disease and overcomes a number of deficiencies in existing clinical trial outcome measures. In Parkinson’s disease, clinical trial outcomes are often based on subjective patient reported inputs, such as diaries, which are time consuming for patients and often inaccurate due to reliance on patient recollection and poor compliance. Traditional point-in-time rating scales (UPDRS, AIMS) are cumbersome and reliability is impacted by inter and intra-rater variability.
The PKG system can be deployed remotely and does not require subjects to attend a site visit. Further features and benefits of the PKG system are set out below:
|PKG feature||Benefits in clinical studies|
|PKG is an objective assessment system||
|PKG is easy to use and requires minimal involvement by the patient||
|Real world data collection that can be initiated and managed remotely||
|PKG meets validation and regulatory requirements||
|Comprehensive and robust data delivery||
If you would like to get in contact with us to discuss how you can utilise the PKG system to support your clinical trial, please complete the following inquiry form.