Global Kinetics Corporation (GKC) and the Parkinson’s Foundation have announced that the first of over 400 patients has been enrolled in the GKC APPRISE clinical study.
The multicentre, randomised, controlled study will assess the use of the Personal KinetiGraph (PKG) system for identifying patients who require a change to their clinical management plan and the platform’s ability to help improve patient outcomes.
The APPRISE study is part of the Parkinson’s Foundation Parkinson’s Outcomes Project. Data from the study will be used to build evidence that supports GKC’s strategy to achieve reimbursement for US payers.
“Our goal with the Parkinson’s Outcomes Project is to identify clinical practices that make a real difference to patient outcomes,” says Peter Schmidt, senior vice president and chief mission officer, Parkinson’s Foundation.
The PKG system is the first digital health technology to provide a continuous and objective measurement of Parkinson’s symptoms. This objective data, captured by the PKG-Watch over seven days, is combined with GKC’s proprietary analysis, to produce detailed reports that allow treating clinicians to accurately monitor Parkinson’s symptoms in relation to factors such as medication dose and timing, sleep and exercise.
Rajesh Pahwa, principal investigator at Kansas University Medical Center, Kansas, USA, the site of the first enrolled patient, says, “As a Parkinson’s Foundation Center of Excellence, we are excited to be part of the first US randomised study evaluating the use of the PKG in the Parkinson’s disease population. In our clinic, using the PKG has helped us to better understand patients’ motor states during the day and allows us to better plan their treatment. Our patients also benefit from using the PKG, as it helps them better understand their motor fluctuations, bradykinesia and dyskinesia.”
Treating Parkinson’s disease is challenging as patient symptoms can fluctuate from day to day and throughout the course of a day. These fluctuations may be caused by the progression of the disease or as a complication of their medication.
“Neurologists typically ask patients to keep a written diary to track fluctuations, but a device has the potential to be easier to use for the patient, easier to understand for the clinician and more accurate,” says Schmidt. “The PKG automatically records patient symptoms with no intrusion on their daily activities, so our hope is that it will make a difference in routine care.”
This clinical study is the first to systematically evaluate the use of wearable sensors for optimising dose and timing of Parkinson’s medications, as well as measuring the impact of medication changes on patient outcomes, in a multicentre, routine care setting in the USA.
“From the clinician’s perspective, the value of the Personal KinetiGraph resides in the objective information provided by the PKG to guide therapeutic decisions and measure changes in patient outcomes,” explained Professor Malcolm Horne, Global Kinetics’ co-founder and chief scientific officer. “The objective nature of the data allows for more informed assessment than can be achieved with clinical assessment alone. The interim results of a 2016 pilot study showed that the PKG was able to detect uncontrolled symptoms in patients that were thought to be well controlled when assessed clinically.”
Horne continues: “From the patient’s perspective, one of the key benefits of the PKG is the non-intrusive nature of the data collection and user-friendly features such as the medication reminders. Importantly, the PKG allows people with Parkinson’s to better understand their condition and have more informed discussions with their clinicians.”