A multi-center, randomized controlled trial to assess whether the use of continuous objective measurement of changes in mobility in patients with Parkinson’s disease can improve physician treatment decisions and patient outcomes.
Melbourne, Australia & Miami, FL — Global Kinetics Corporation, developer of the Personal KinetiGraph™ (PKG™) mobile health technology for the management of patients with Parkinson’s disease and other movement disorders, and the National Parkinson Foundation (NPF) today announced a clinical research collaboration to study the impact of continuous objective measurement of movement in patients with Parkinson’s disease using the Personal KinetiGraph™ (PKG™) Movement Recording System.
Developed by Global Kinetics, the PKG™ System provides a precise, objective assessment of changes in mobility in patients with diseases and conditions that affect motor skills. The PKG™ is a wrist-worn device that automatically records motion data over a period of 6 days. Physicians can download detailed information about the patient’s symptoms within minutes, identifying changes and trends that can be important considerations in the diagnosis and treatment of Parkinson’s disease. The device can also alert patients when it’s time to take medication as prescribed and the patient can acknowledge medication taken using the device.
This clinical research project will be a multi-center randomized controlled trial involving over 400 Parkinson’s patients conducted as part of the NPF Parkinson’s Outcomes Project Registry Study which began in 2009 as a core element of the NPF Quality Improvement Initiative. The study has grown to become an unprecedented research collaboration among over 20 leading A neurologist with extra training (usually a one- or two-year fellowship) in Parkinson’s and other movement disorders. centers and is now the largest clinical study of Parkinson’s disease with nearly 9,000 patients enrolled across four countries. “Our goal with the Parkinson’s Outcomes Project is to identify clinical practices that make a difference in patient outcomes. The hope is that this new PKG™ study will show how we can use technology to provide information to guide better and more effective clinical decisions, helping more people with Parkinson’s to achieve the best outcomes they can, and that we will be able to translate this into other care settings,” said Peter Schmidt, PhD, NPF Senior Vice President and Chief Mission Officer.
“We are pleased that NPF have recognized the PKG as an essential tool in the management of Parkinson’s and are pleased to be able to partner with them on this A research study in humans that aims to test a new intervention – this could be a drug, surgery or therapy like exercise or diet guidelines – to make sure it is effective and safe.. One of the great challenges in clinical care of people living with Parkinson’s disease is the subjective nature of symptom observation, which can lead to wide variability in use of medicines and in treatment protocols,” said Global Kinetics Corporation co-founder and Chief Scientific Officer, Professor and neurologist Malcolm Horne. “The PKG™ provides continuous, precise, and accurate assessments of changes in mobility in patients with Parkinson’s disease, which can play an important role in helping make informed treatment decisions, this allows clinicians to provide optimum treatment and ultimately leads to better outcomes for people with Parkinson’s.”
According to data from the NPF Parkinson’s Outcomes Project thus far, there is currently wide variability in the use of different medicines and treatment plans in Parkinson’s disease. In planning for patient care, physicians typically rely on clinical evaluation, a patient’s self-reporting of symptoms[i] and response to medication to guide therapy, potentially increasing the risk of inconsistent and diverse outcomes. “Some Parkinson’s patients are thriving, while others are not. Our goal is to determine what makes that difference. By including the PKG™ System as an element of routine care, this study will enable us to consider the interplay of continuous objective measures of patient mobility among the other factors that ultimately produce different results in different people, and likely paths toward better outcomes. Our goal is not only to optimize today’s care of Parkinson’s patients, but also to help guide tomorrow’s,” said Dr. Schmidt.
“The PKG™ System was FDA cleared in the U.S. in 2014, and many leading clinicians now have extensive experience with this technology, making this an ideal time to initiate this important clinical study,” Professor Horne said. “This is one of several post-marketing studies currently underway with the PKG™ that will provide a wealth of new data highlighting the role that objective assessment of symptoms can play in improving patient care in Parkinson’s disease in the years ahead.”
About Parkinson’s Disease
Parkinson’s disease (PD) is a chronic, progressive movement disorder that affects the lives of at least one-half million patients in the United States[ii]. The main motor (or movement) related symptoms of Parkinson’s disease are Slowness of movement., In Parkinson’s, stiffness of the arms or legs beyond what would result from normal aging or arthritis. Some people call it “tightness” in their limbs., tremors and Impaired balance and the tendency to fall without explanation, usually when pivoting; a common symptom in the later stages of Parkinson’s.. [iii] Other non-movement symptoms include speech and swallowing difficulties, cognitive impairment, A mood disorder whose symptoms can include a persistent sad or empty mood, feelings of hopelessness or pessimism, irritability and loss of interest or pleasure in previously enjoyable activities. or other emotional changes. As the disease progresses, symptoms may interfere with daily activities. Parkinson’s disease can be difficult to diagnose and currently there is no cure. [iv] However, a variety of medications and surgery can help ease the symptoms for some patients.[v]
About Global Kinetics Corporation
Global Kinetics Corporation is committed to improving the lives of those with Parkinson’s disease and other movement disorders with advanced medical technologies. The company was formed in 2007 to commercialize its lead product, the Personal KinetiGraph™ (PKG™). Developed by neurologists at the world-renowned Florey Institute of Neuroscience & Mental Health in Melbourne, Australia, the Personal KinetiGraph™ enables the precise monitoring, quantification and reporting of movement symptoms of neurological diseases. Global Kinetics Corporation, a privately held company, is headquartered in Melbourne, Australia. For more information visit: www.globalkineticscorporation.com.
[i] NINDS Parkinson's Disease Information Page: What is the prognosis? National Institute of Neurological Disorders and Stroke, accessed Sept. 4, 2014. Available at: http://www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease...
[ii] Parkinson's Disease Research Web Overview, National Institute of Neurological Disorders and Stroke, accessed Sept. 4, 2014. Available at: http://www.ninds.nih.gov/research/parkinsonsweb/index.htm
[iii] NINDS Parkinson's Disease Information Page, National Institute of Neurological Disorders and Stroke, accessed Sept. 4, 2014. Available at: http://www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease...
[iv] NINDS Parkinson's Disease Information Page: What is the prognosis? National Institute of Neurological Disorders and Stroke, accessed Sept. 4, 2014. Available at: http://www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease...
[v] NINDS Parkinson's Disease Information Page: What is the prognosis? National Institute of Neurological Disorders and Stroke, accessed Sept. 4, 2014. Available at: http://www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease...