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PKG Wristwatch Device May Improve Clinical Decision-Making in Parkinson’s, Study Shows

PKG wearable monitoring device

A wrist-worn medical device — called the Personal KinetiGraph or PKG — that reminds people with Parkinson’s disease to take their medication, and records their movements to provide physicians with objective measurements of motor symptoms, showed great promise as a tool to improve clinical decision-making, a study found.

When worn for six days before a routine care visit, the device reported disease-related motor symptoms, like dyskinesiainvoluntary muscle movement — and bradykinesia, or the progressive slowness of movement over time, even when patients did not report such symptoms.

Overall, the device provided information for better treatment plans, allowed doctors to assess the efficacy of treatments, and improved doctor-patient communication.

The findings were reported in “PKG Movement Recording System Use Shows Promise in Routine Clinical Care of Patients With Parkinson’s Disease,” a study published in the journal Frontiers in Neurology.

The focus of Parkinson’s disease treatment is the relief, through medication, of symptoms like slow movements, rigidity, and tremor. However, such treatment regimens rely on patient self-reported symptoms, which often can be unreliable, even with validated assessments such as the Unified Parkinson’s Disease Rating Scale (UPDRS).

In addition, patients tend to do better during their appointments and clinical examination than at home.

The lack of objective data complicates treatment recommendations.

To overcome these problems, Global Kinetics Corporation (GKC) developed PKG, a watch-like device that objectively records movements and reminds patients to take their medication. The device was cleared for use by the U.S. Food and Drug Administration in September 2016. It weighs 35 grams, and is programmed and dispensed by clinical staff and worn by the patient for 6–10 full days.

The PGK uses accelerometers to monitor movement and a proprietary mathematical algorithm to convert the raw movement data into a PKG report — a graphical illustration of the patient’s movement that the clinician can analyze. That report provides “scores representative of dyskinesia and bradykinesia, compared to controls, throughout the day and from day to day,” the device’s website says.

To evaluate the clinical utility of the PKG, physicians at the University of California, Irvine (UCI) and University of California, Los Angeles (UCLA) now conducted a single-arm, open-label, observational study. The study included 63 people with Parkinson’s, ages between 46 and 83 years, who were responsive to dopaminergic therapy. In total, the patients had 85 routine care visits.

The main goal was to determine how often symptoms reported by patients disagreed with those in the PKG report. Secondary measures included the number of times the PKG report had findings that were treatable, how often doctors changed treatment based on the PKG report and how the report impacted patient care. Patients and caregivers’ satisfaction with the device also was measured.

The study’s participants wore the PKG for six continuous days before their appointments. Physicians then discussed symptoms with their patients and conducted a motor examination prior to uploading and reviewing the PKG report.

The team found that the PKG report demonstrated the presence of symptoms not reported by patients in 35% of the visits. Among these symptoms, bradykinesia was the most common finding of the PKG not picked up by the patient (50% of cases), followed by dyskinesia (33%). In contrast, 24% of patients reported a symptom that did not appear in the PKG report.

Regarding treatable symptoms, the device identified those individuals who could benefit from increases in levodopa doses or other treatments, including 47% of those with bradykinesia and 44% of those with dyskinesia.

In total, the report provided insights used to change treatment plans in 79% of participants, improved dialogue with the patient in 59% of visits, improved the ability to measure treatment impact in 38% of visits, and improved motor assessment in 33% of visits.

When surveyed at the end of the study, 82% of the participants agreed or strongly agreed that the PKG was easy to learn, easy to use, enabled them to confirm medication administration, and performed as expected. These patients said they would use the device again. In 39% of responses, participants also reported a very valuable impact on their care.

A 75-year-old women included in the trial “had difficulty reporting when she was off [when levodova effects wear out] and when she was dyskinetic,” the researchers said. “The PKG identified off times in the [morning] and dyskinesias in the afternoon. Based on the PKG data her regimen of carbidopa/levodopa dose was adjusted and her symptoms markedly improved.”

The researchers noted that the study was limited by the small number of patients. However, they said the results showed the usefulness of the new medical device.

“The PKG system provided clinical utility through improved characterization of motor manifestations of Parkinson’s disease, both the type and timing. This served to improve physician-patient dialogue and provide insight to clinicians and patients to inform treatment impact and decisions,” the team concluded.

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PKG Wearable Device Objectively Detects Motor Fluctuations, Dyskinesia, Study Shows

PKG motor fluctuations

A wearable motion-tracking device called Personal KinetiGraph (PKG) objectively and effectively assesses Parkinson’s-related motor fluctuations, researchers report.

The study, “The role of Personal KinetiGraphTM fluctuator score in quantifying the progression of motor fluctuations in Parkinson’s disease,” was published in Functional Neurology.

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

The technology also assesses patients’ motor fluctuations, immobility, and daytime somnolence, or sleepiness. Clinicians also can use it to help study an individual’s likelihood for developing impulsive behaviors, and to collect information on medication compliance.

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

Previous studies have shown that PKG is able to distinguish between patients with and without motor fluctuations. Now, investigators at the Cedar-Sinai Medical Center in Los Angeles set up to determine whether the cut-offs of PKG motor fluctuation scores could define the progression of Parkinson’s fluctuation stages.

A total 54 Parkinson’s patients — 37 men and 17 women, mean age of 68 years — used the PKG device for 6 days. The participants then were asked to complete a 2-day standardized motor diary, essentially a journal in which the individuals would self-report and record their motor symptoms.

By applying clinically validated scales and questionnaires, researchers were able to categorize the participants into four groups: non-fluctuators (14 people), or patients without motor fluctuations; early (15 people); moderate (15 people); and troublesome fluctuators (10 people), or individuals with motor fluctuations due to a decline in the usual benefit of levodopa therapy.

Of the 54 individuals who completed the PKG trial, only 39 completed and delivered valid motor diaries. Compliance with the motor diary improved with decreasing severity of motor fluctuations — meaning that patients with less severe fluctuations were more likely to complete the diary.

PKG data revealed the device’s fluctuation scores significantly differentiated early fluctuators and troublesome fluctuators, as well as dyskinetic and non-dyskinetic patients.

Meanwhile, patient-reported motor diaries could not distinguish the four study groups based on the average “off” time, the researchers said.

Dopaminergic medications enable Parkinson’s motor symptom control — meaning that treatment temporarily stops the symptoms. However, as the disease progresses, patients typically need to gradually increase the treatment dose to get the maximum benefit. Even after that, however, they may still experience the reappearance or worsening of symptoms — known as “off periods” — due to the diminishing effects of the therapy.

Average time with dyskinesia, or abnormal involuntary movements, distinguished the non-fluctuators and moderate fluctuators. Importantly, the PKG system identified high dyskinesia scores in patients who denied having it.

“Motor fluctuations, including ‘wearing-off’ and dyskinesia, are associated with increased disease severity and disability, and PD [Parkinson’s disease] patients experience decreased quality of life as their response to medical therapy becomes less predictable,” Echo E. Tan, MD, neurologist at Cedar-Sinai Medical Center and the study’s lead author, said in a press release.

“Effectively managing motor fluctuations is complicated by the lack of objective assessment tools, leading patients and physicians to rely on direct observation in the clinic or patient reports, which may be unrevealing, incomplete and unreliable,” Tan added.

The researchers noted that “wearable devices transcend language barriers, cognitive barriers, as well as time constraints in the clinic.” That makes this wearable device a useful tool to objectively measure motor fluctuations in Parkinson’s disease.

“The results of our study demonstrate that the fluctuation score calculated by the PKG system provides objective quantification of motor fluctuations. This may help improve routine management of PD [Parkinson’s disease] patients and enable more objective assessments in clinical trials of PD [Parkinson’s disease] therapies,” Tan concluded.

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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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PKG-Watch Helps in Managing Parkinson’s Symptoms and Lowering Patient Costs, Global Kinetics Reports

wearable monitoring device

Global Kinetics recently announced that the use of its wearable device, Personal KinetiGraph ­­(PKG)-Watch, significantly improves the assessment and management of Parkinson’s disease symptoms, while reducing patients’ costs.

These results were presented in four scientific posters at the International Congress of Parkinson’s Disease and Movement Disorders, held Oct. 5-9 in Hong Kong.

The PKG-Watch is a wrist-worn device that collects data on a patient’s movement, providing information regarding motor symptoms of Parkinson’s — such as tremor, slow or involuntary movements, motor-skills fluctuations, and immobility — 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. Earlier this year, the company announced that the PKG-Watch was recommended by two separate expert panels to improve clinical management of Parkinson’s disease.

A previous population study using a database of more than 10,000 Parkinson’s patients worldwide who wore the PKG-Watch showed that this technology had the potential to provide clinicians with a passive and continuous assessment of patients’ symptoms, helping them  to better understand disease progression and to optimize treatments.

The study, “Objective Data in Parkinson’s Disease: A description of over 20,000 Parkinson’s symptom scores across the world using the Personal KinetiGraph (PKG),” showed updated results from that growing database, involving 21,234 PKG-Watch users worldwide from 2012 to 2018.

Data supported previous findings, showing that a substantial proportion of patients have suboptimal management of their motor symptoms, with high levels of slowness of movement, tremors, and daytime immobility.

Among these patients, 54% had uncontrolled but likely treatable slowed movement, and 10% had uncontrolled but likely treatable involuntary movements.

Subsequent use of the PKG-Watch significantly improved patients’ motor symptoms, suggesting that the data collected and provided did help clinicians to optimize treatment and improve motor symptom management.

Similar results were presented in the poster “Personal KinetiGraph™ Movement Recording System: An Assessment of Utility in a Movement Disorder Clinic,” regarding an open-label study that involved 28 Parkinson’s patients wearing the PKG-Watch.

The study also showed that patients reported the device had a positive impact on their care, assessing their daily activity levels (96% of patients), providing data that helped to manage their disease (93%) and they could not otherwise provide to their physician (89%), and explaining symptoms (79%).

Another study, titled “Costs and outcomes for Parkinson’s disease patients who have their management adjusted by Personal KinetiGraph (PKG),” assessed the potential cost savings for 33 Parkinson’s patients in Northern Tasmania, Australia, whose oral therapy was adjusted with guidance from the PKG-Watch.

Better disease management associated with the use of PKG-Watch contributed to an estimated annual cost savings of AU$1,719.42 per patient, results showed.

The study, “Pilot economic evaluation of Personal KinetiGraph (PKG) for management of Parkinson’s disease in Australia,” also supported PKG-Watch use being tied to cost savings.

It showed that even small additional therapeutic benefits associated with PKG-Watch contribute to lesser resource utilization and lower cost, compared to current usual care. The study estimated that PKG-Watch use contributed to an annual savings of AU$962 per patient.

“We are pleased to share this data, as well as having our PKG device be used as an objective measurement tool in the clinical care setting,” John Schellhorn, Global Kinetics’s CEO, said in a press release.

“We are also excited that our PKG smartwatch is being used in multiple clinical studies conducted by pharmaceutical and biotechnology companies to evaluate potential new therapies,” Schellhorn added.

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Global Kinetics Gets Funding for Trial of Its Wearable Device for Recording Parkinson’s Movement Data

Wearable device trial

Global Kinetics Corporation has obtained $350,000 in foundation funding to conduct a global clinical trial of its wearable device for recording Parkinson’s patients’ movement information.

In addition to tracking movement, the watch-like Personal KinetiGraph reminds patients to take their medication and records when they do.

The Michael J. Fox Foundation, Shake It Up Australia Foundation and Parkinson’s Victoria put up the trial money.

With many chronic diseases, doctors have ways to monitor symptoms and adjust treatments. Examples are blood sugar levels in people with diabetes and blood pressure in those with heart disorders. But no such metric exists for Parkinson’s disease.

“The experience of Parkinson’s varies day to day, hour to hour,” Mark Frasier, senior vice president of research programs at the Fox foundation, said in a news release. “An objective tool, such as the wearable PKG [Personal KinetiGraph] technology, that passively collects data on the lived experience of Parkinson’s disease outside the clinic” could help, he said.

It “could give patients and their doctors greater insight to calibrate treatment plans and improve outcomes and give scientists a metric with which to measure therapeutic impact and test potential therapies faster,” Frasier said.

The Personal KinetiGraph records Parkinson’s patients’ movement information while they are at home and performing their daily activities, without interfering with the activities.  The information can show if a patient is having difficulty moving or is moving slower.

Once the results are uploaded and processed, they are emailed to the patient’s doctor. He or she gets both raw numbers and graphics that show patients’ involuntary movements and whether they are moving too slowly.

The doctor also obtains information on patient’s movement fluctuations, immobility, tremors, and whether they are taking their medication.

A previous study showed that Personal KinetiGraph has the potential to help assess patients’  symptoms, collect information useful to understanding the progression of their disease, and personalize their treatments.

The Treat-to-Target trial’s main objective will be to see if the device helps improve the routine care of Parkinson’s patients.

Global Kinetics designed the trial after research showed the benefits of using objective assessments and treatment targets for Parkinson’s disease.

The study will cover 225 patients in Australia, Europe and the United States. Researchers will follow them for 18 months. The trial has already started in Australia. Patient recruitment in the U.S. and Europe is expected to start soon.

Interim results are expected by December 2018. Final results and guidelines for doctors’ use of the device will be released in early 2019.

“Shake It Up Australia is excited to support the PKG technology in this trial,” said Clyde Campbell, the organization’s founder and chief executive officer. The device gives patients, their neurologists and researchers “a real-life picture of current symptoms and responses to medications” — information that can make a difference in how Parkinson’s progression is dealt with, he said.

 

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