Parkinson’s KinetiGraph System (PKG)

The PKG System is designed to address the shortfalls of current methods and better enable patients to be optimally controlled. • Providing a quantitative measure of fluctuating symptoms day to day rather than a snap shot in time during a clinic visit • Differentiating between Parkinson's states, which can be confused or influenced by recall bias. • Eliminating variability in current methods. Persons with Parkinson's and clinicians each have their own “perceived normal”. With the PKG System is it possible to: • Identify uncontrolled patients • Optimize treatment for sub-optimally controlled patients • Empower patients • Decrease healthcare costs

The PKG Watch reflects both traditional watch face styling cues and the latest global trends in the wearable smartwatch market. This significant change in design thinking enables people with Parkinson's to have access to a wearable medical device in a discreet watch form without a constant reminder of their chronic disease. The watch is designed to suit both male and female wrists and is neutrally colored so as not to make an overt statement or draw unnecessary attention to the wearer. A simple stainless steel accent frames the digital display presenting a classic timepiece quality. The touch screen LCD features an analogue watch face which makes way to display a range of visible on screen and vibratory alerts.

The PKG Watch Strap is specifically designed with the cognitive and dexterity limitations of people suffering from Parkinson's disease in mind. The Wrist Strap is available in two sizes to fit both male and female wrist circumferences up to the 95% percentile. Velcro fastening allows fine adjustment to ensure the PKG Watch is firm against the wrist for best recording results. As patients struggle with traditional watch straps, the open ends can be temporarily looped together so the strap can be simply slid over the hand. By anchoring the Watch against the leg, a patient can pull the Velcro hook end tight and fasten against the loop. An optional retainer slid over the exposed end prevents accidental separation.

The PKG Watch is designed to promote simple operation and minimise patient confusion. Once activated, the Watch will regularly alert the patient at the doctor prescribed medication times. This is performed through a combination of both visible on-screen and vibratory alerts. After taking their medication, the patient is required to perform a successful acknowledgement by swiping the touch screen LCD in a slow gestural left to right motion and receive positive confirmation. In the event that an incorrect acknowledgement is performed the alert sequence will recommence. At the end of the recording period an envelope appears on the screen to instruct the patient to return the PKG Watch.

The design of the PKG System allows new features resulting from future clinical research or technological development to be easily integrated without significant electromechanical changes taking place. The PKG Watch contains a tri-axial accelerometer, a range of temperature, light measurement sensors and Bluetooth adaptable for other indications for use. These further enhance measurement; enable remote monitoring of symptomology and treatment outcomes. Aiming to improve decision making and clinical outcomes. The removable PKG Watch design also allows for future alternate wrist strap styles and configurations to be developed, such as those required for full time use.

The PKG Watch is designed to be worn 24/7, for monitoring over a period of 6 days without the need to remove or charge the device. Outwardly functioning like a watch, it fits seamlessly and discreetly into a patient's day to day life whilst recording silently in the background. With its comfortable, easy to clean and removable watch strap and IP67 waterproof casing with touch screen LCD, it is easy to maintain and operate and therefore encourages continuous usage. By empowering patients to improve daily decision making outside the clinic with respect to their Levodopa medication compliance, it intended to have a net benefit of improving their quality of life.

The PKG System is supplied complete with its own configuration software which is used to quickly programme the PKG Watch with required patient information and Levodopa medication reminder times. Following the recording period, the PKG Watch is reconnected to the tablet via the docking cable and automatically sends the collected data wirelessly to a cloud based server which analyses the data, generates a PKG report. For convenience, the tablet also automatically downloads and stores its own copy. The PKG System is fully portable enabling Clinicians to come directly to the patient. Furthermore a post out model allows the PKG Watch to be configured without face to face consultation.