Wearable PKG System Can Help Identify Parkinson’s Patients Eligible for Device-Assisted Therapy, Study Shows

PKG system, DAT scores

Data collected through Global Kinetics Corporation’s wearable device called Personal KinetiGraph (PKG) can help clinicians identify Parkinson’s patients who may benefit from deep-brain stimulation (DBS) or other device-assisted therapies.

This finding was reported in the study, “The Use of Data from the Parkinson’s KinetiGraph to Identify Potential Candidates for Device Assisted Therapies,” published in the journal Sensors.

The PKG system is a wristwatch-like device worn on the side of the body that is most affected by the disease and continuously collects patients’ movement data — such as tremors, slow or involuntary movements, motor skill fluctuations, and immobility.

The device has been cleared by the U.S. Food and Drug Administration and holds CE certification, meaning it meets European safety, health, and environmental protection requirements. Global Kinetics recently announced that its PKG-Watch was recommended by two separate expert panels to improve the clinical management of Parkinson’s disease.

PKG movement data can provide detailed information on the progression of patient’s motor symptoms, as well as on the effectiveness of available therapies to manage them.

Researchers have now evaluated if PKG data could also be used as a screening tool to identify Parkinson’s patients who may benefit from device-assisted therapies (DAT) such as deep-brain stimulation.

“Despite broad consensus as to the criteria for selecting DAT candidates, non-specialists have difficulty in recognizing these criteria. Many [people with Parkinson’s disease] in whom fluctuations are emerging are managed by non-specialists and consequently, suitable DAT candidates are not referred in a timely manner,” the researchers wrote.

The potential for DATs to effectively help manage Parkinson’s symptoms relies mainly on treatment timing, with delays meaning that “suitable candidates may have shorter benefit from DBS or worse still, miss out entirely,” they said.

In fact, “as many as 67% of patients referred for DBS are unsuitable for the procedure yet only 1% of people with Parkinson’s disease receive DBS, even though as many as 20% may, in fact, be eligible,” they added.

“Although there is broad consensus with respect to the criteria for selecting PD patients who will benefit from DBS, these symptoms may be difficult for physicians to identify when relying on patient self-report or in-clinic exam findings that may not reflect the spectrum of the individual’s symptoms and result in treatment delays,” Fatta Nahab MD, associate professor of neurosciences at the University of California San Diego, said in a press release.

Now, researchers at the University of Melbourne in Australia, in collaboration with Global Kinetics, developed a new assessment score, which they call the DAT score. This tool was designed to specifically predict the likelihood that a Parkinson’s patient is a suitable candidate for DAT based on PKG movement data.

An initial group of 172 patients with Parkinson’s was evaluated by a clinical team who identified them as either suitable or not suitable for DBS treatment. Those who were positively selected for DAT were younger and had worse motor symptoms, measured by Unified Parkinson’s Disease Rating Scale (UPDRS) scores.

All patients were asked to use the PKG device, which continuously recorded their movement data. Based on the collected data and according to the initial clinician’s assessment, the researchers selected the most useful parameters that allowed them to differentiate patients who were positively selected for DAT from those who would not be eligible.

The feasibility and accuracy of the DAT score was then tested in a second group of 31 patients with Parkinson’s who had been selected to undergo DBS, 81 patients who were managed in a non-specialist clinic, and 22 patients who had been diagnosed within the past five years.

PKG data was highly sensitive and specific for classifying Parkinson’s patients for DAT eligibility based on the recommendations of specialist clinicians.

Furthermore, the PKG-based DAT score was able to correctly identify 87% of patients who were referred for DAT, namely DBS, in different clinical settings, 92% of patients managed in a non-specialist clinic, and 100% of patients who were within the first five years of diagnosis.

Importantly, DAT scores changed as expected when therapeutic interventions were sufficient to resolve troublesome motor fluctuations or dyskinesia (involuntary movements) that would otherwise have required DAT.

These results demonstrate that “[movement] information from objective measurement [with the PKG device] could improve timely referral for DAT,” the researchers wrote.

“The lack of objective measurements for Parkinson’s symptoms has been a barrier to optimizing care and outcomes for Parkinson’s patients across the continuum of disease,” said John Schellhorn, CEO of Global Kinetics Corporation. “Objective, reproducible assessment methods that allow for data-driven clinical decision-making in the treatment of Parkinson’s can help benefit patients, physicians and overall healthcare costs.”

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#AANAM – Data Recorded from PKG Wearable Device May Help Clinicians Choose Better Treatment, Study Says

Personal KinetiGraph (PKG)

A wearable device called Personal KinetiGraph (PKG) can continuously and objectively monitor motor symptoms in people with Parkinson’s disease, which can help clinicians select the most appropriate management therapy and assess treatment impact, a study finds.

The study, “Objective Data in Parkinson’s Disease: A Description of Over 27,000 Parkinson’s Symptom Scores Across the World Using the Personal KinetiGraph® (PKG®),” was presented as a scientific poster during the 2019 American Academy of Neurology’s (AAN) Annual Meeting in Philadelphia.

The PKG system, developed by Global Kinetics Corporation, is a wrist-worn movement recording device that collects data on the person’s motor symptoms, including tremors, slowness of movement (bradykinesia), and abnormal involuntary movements (dyskinesia).

The technology also assesses patients’ daytime somnolence (sleepiness), studies their likelihood for developing impulsive behaviors, and provides information on medication compliance, motor fluctuations, and immobility.

The device has been cleared by the U.S. Food and Drug Administration (FDA), and holds CE certification, meaning it meets EU safety, health and environmental protection requirements.

Previous validation studies have correlated PKG objective scores with other standard Parkinson’s scales, like the Unified Parkinson’s Disease Rating Scale (UPDRS). However, there still is no consensus about the indications for PKG and which patients should wear the device.

To learn more, researchers studied 27,834 complete PKGs — with any identifying data removed — recorded worldwide between January 2012 and March 2018.

Analysis showed 54% of patients had uncontrolled, but likely treatable, slowness of movement, while 10% had uncontrolled, but also likely treatable, dyskinesia. Individuals who used their PKG device regularly had their PKG scores improve, meaning their symptoms became more controllable. That suggests the technology may help to improve clinical decisions, and consequently disease management.

Data from another study, “An Observational Study of PKG Movement Recording System Use in Routine Clinical Care of Patients with Parkinson’s Disease,” was presented in April at the 2019 Parkinson Study Group (PSG) Annual Meeting. That data showed that using Global Kinetics’ technology improved dialogue with patients in more than half of the cases, and enhanced clinicians’ ability to assess treatment impact.

“At Global Kinetics, we are committed to serving the Parkinson’s disease community and providing access to our PKG, which can provide objective measurement in the clinical care setting and help optimize care in this neurodegenerative disease. These presentations underscore the value of PKG in providing valuable information about Parkinson’s movement symptoms and allowing neurologists and movement disorder specialists to have more meaningful conversations with their patients, which translates to optimized care,” John Schellhorn, CEO of Global Kinetics Corporation, said in a press release.

More than 40,000 patient PKG reports have been recorded so far, which has helped more than 200 Parkinson’s specialist clinics to adjust treatment choice and improve management for their patients, according to the release.

Global Kinetics now is enrolling participants in APPRISE, a prospective, multi-center, controlled trial (NCT03741920) designed to evaluate the utility of PKG movement recording system data in the clinical management of Parkinson’s disease in routine clinical care.

Researchers believe PKG recording positively influences clinical decisions, enabling better disease control. In APPRISE, treatment changes with or without the use of PKG data will be evaluated. Participants will have to wear the device for 90 days. Scientists plan to enroll 438 participants across 10 U.S. Movement Disorder clinics. Enrollment is by invitation only.

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Pilot Project Tests Wrist Device That Monitors Symptoms at Home

wearable technology

A pilot project in the United Kingdom is testing a wrist device that is worn like a watch, called Personal Kinetigraph (PKG), to help Parkinson’s patients and their specialist healthcare providers to monitor their condition at home.

The PKG, developed by Global Kinetics, will be tested in the “Developing Home-based Parkinson’s Care” project, led by researchers at the University of Plymouth and University Hospitals Plymouth NHS Trust (UHPNT).

The wearable technology monitors patients’ motor symptoms, using a proprietary algorithm to process the data. Participants also are asked about their non-motor symptoms, including changes in mood, to supplement the movement data delivered by the PKG.

Patients will wear the device for six-day stints, during which their care team will identify and implement necessary treatment changes. The specialist Parkinson’s team will work remotely to ensure necessary help — calls or clinical appointments — is offered when needed.

In the U.K., current guidelines recommend that Parkinson’s patients see a specialist every six months, no matter the stage of their condition. Care is usually provided by a consultant and community Parkinson’s disease nurse specialist (PDNS).

However, results from a recent survey showed that almost half of these appointments (46%) are delayed by more than six months. In 60% of the cases, patients can go an entire year without an appointment. Some regions of the U.K. don’t have the specialist service, and 50% of vacant PDNS positions are due to long-term sick leave or resignation, the audit showed.

“The UK prevalence of Parkinson’s disease will increase by a fifth by 2025, so the challenges associated with providing a timely and patient-centered service will also be much higher,” Camille Carroll, the project leader and an associate professor at the University of Plymouth’s Institute of Translational and Stratified Medicine (ITSMed), said in a press release.

“The existing service puts a lot of pressure on nurses, and attending clinics is arduous for both patient and carer as it presents logistical and physical challenges that add to burden and distress,” said Carroll, also a consultant neurologist at UHPNT.

“We want to help people with Parkinson’s to live the best lives they can for as long as they can, and this project aims to empower patients to take control of their own condition,” she added.

The project will start with 150 patients from Plymouth city, West Devon and East Cornwall.

“The new project is designed to reduce the burden of attending hospital clinics; improve motor and non-motor Parkinson’s symptoms; ensure appropriate and timely contacts to health-care services; and result in improved quality of life for people with Parkinson’s and their carers,” Carroll said.

“If successful, the intervention will prove a means of providing a resilient and sustainable service faced with the future demands of a condition that is increasing in prevalence and complexity,” she added.

The project also will bring together both clinicians and caretakers by providing “co-design workshops” to ensure that patients’ needs and expectations are assessed and met.

A Parkinson’s patient from Looe who is enrolled in the project is pleased with the device’s ease of use.

“Using the PKG is simple and gives the specialist an easy and quick way of monitoring my Parkinson’s disease remotely. Hopefully the new service design will make life easier for others like myself living with the condition,” John Whipps said.

“One of the hardest things with Parkinson’s is trying to decide when your Partner needs their extra doses of medication. The PKG results help take the guesswork out of that, which is really valuable for ensuring the best care possible,” said Sue Whipps, his wife and caregiver.

The pilot project is being delivered in partnership with the Cure Parkinson’s Trust, Flourish Workplace, Sheffield Hallam University, Global Kinetics Corporation, Parkinson’s UK, Fre-est, Radboud University, the South West Academic Health Science Network (SWAHSN) and UCB Pharma.

It’s been funded with £75,000 ($97,619) from the Health Foundation and £15,500 ($27,176) from a Parkinson’s UK Excellence Network Service Improvement Grant.

“The PKG is an exciting example of how technology has the potential to transform care in conditions like Parkinson’s,” said Julie Dodd, director of Digital Transformation at Parkinson’s UK.

“People tell us that one of the most frustrating things about the condition is how unpredictable it is, no two days are the same, which makes it incredibly hard to plan,” Dodd added.

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Monitoring with PKG System Helps Change Care in Nearly a Third of Parkinson’s Cases, Real-World Study Reports

PKG recording system

Continuous monitoring of movement symptoms using a wearable device called the Personal KinetiGraph (PKG) may help clinicians make more appropriate treatment choices for their patients with Parkinson’s disease, according to a real-world clinical study.

The study, “Qualitative Evaluation of the Personal KinetiGraphTM Movement Recording System in a Parkinson’s Clinic,” was published at the Journal of Parkinson’s Disease.

Parkinson’s is a progressive disease characterized by the degeneration of dopamine-producing neurons, causing several motor symptoms such as bradykinesia — slowness of movement — muscular rigidity, and tremor.

Although Parkinson’s can cause a range of non-motor symptoms, such as sleep problems, constipation, slurred speech, and mood disorders, management of the disease is mainly focused on reducing the burden of motor symptoms. To do so, clinicians must rely on patients’ reports and one-time clinical assessments to find the most appropriate treatment strategy as well as to make therapy adjustments.

The development of wearable sensors represents a new opportunity to help clinicians more accurately evaluate Parkinson’s patients’ movement patterns.

“New wearable sensors have the advantage of offering continuous objective measurement of patient movement during regular activities of daily living,” the researchers wrote. “[They] have the potential to provide important additional information in a more accurate way to augment day to day clinical care of Parkinson’s patients.”

The PKG system, developed by Global Kinetics Corporation, is a wristwatch-like device worn on the side of the body that is most affected by the disease and continuously collects patients’ movement data — such as tremor, slow or involuntary movements, motor-skills fluctuations, and immobility — providing information to the patient’s doctor.

The PKG system is now commercialized for clinical use in 17 countries, including the U.S. and several European countries. Global Kinetics recently announced that its PKG-Watch was recommended by two separate expert panels to improve clinical management of Parkinson’s disease.

Researchers at the Parkinson’s Institute and Clinical Center in California have now evaluated the impact of using continuous objective movement measurement with the PKG system in the routine clinical care of Parkinson’s patients. The Parkinson’s Institute began using the PKG system in December 2015 as an additional evaluation method on top of clinical visit history and examination.

“The wearable PKG technology provides objective measurements which allow us to further deliver the highly individualized care that a patient deserves,” Carrolee Barlow, MD, PhD, former CEO of the Parkinson’s Institute and Clinical Center and senior author of the study, said in a press release.

In routine care, physicians targeted PKG use to patients they believed could benefit from objective movement measurement — mainly those who were new to the clinic; were experiencing clear symptom fluctuations; were unable to clearly report their symptoms; and were considering or using deep brain stimulation or Duopa (carbidopa/levodopa, marketed by AbbVie).

Between December 2015 and July 2016, 89 patients with Parkinson’s disease were selected to use the PKG system as part of their routine clinical evaluation and follow-up, 81 of whom were included in the final analysis. Forty-five patients had one PKG, and 44 had two PKGs, 10 of whom went on to have three PKGs completed.

Physicians provided their collective views on the impact of the system on patient care in a total of 112 surveys. Of these, 41% indicated that the PKG provided additional information to the physician. However, 59% reported that the system failed to provide additional information.

Of the surveys reporting that the PKG did provide additional information, 78% indicated the data provided by the PKG system resulted in changes in patient care, while 22% revealed “the PKG provided additional information but that no alteration in patient care occurred based on this information,” according to the researchers.

The personalized monitoring system was found to provide new and precise information on daily off time — the period when medication is not working efficiently —  in 50% of the cases.

“Physicians … adjusted treatment nearly a third of the time based on the real-time clinical status captured during objective continuous monitoring outside the clinic setting,” the researchers wrote.

“These results demonstrate the real-world clinical benefits that PKG can provide to patients and clinicians in their continuing effort to optimize Parkinson’s therapy, and manage symptoms effectively,” said John Schellhorn, CEO of Global Kinetics Corporation. “The results of this study support the use of PKG as an important tool for individualizing therapy to best meet each patient’s unique needs.”

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