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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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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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Wearable Sensors Tracking Exercise Show Potential in Parkinson’s But Better Studies Needed, Team Says

wearable biosensors

Researchers at Cedars-Sinai found existing evidence does not support claims that wearable biosensors are improving outcomes for patients with various ills — from obesity to hypertension to lung or heart diseases — although hints of these devices’ potential were seen in some studies in Parkinson’s patients.

A lack of long-term and high-quality research analyzing benefits realized by the range of people using these devices, also known as remote patient monitors, may be a reason for this result, the research team noted. For instance, more than 4,300 studies were considered for this review, but less 1 percent was found to be of sufficient quality.

Among those few included in the final analysis, however, one in Parkinson’s patients looking at gait training exercises found “significantly” better improvements in patients using a biosensor than those given home visits. This six-week program used an ankle device and allowed for remote feedback.

Another six-week at-home physical therapy study, with Parkinson’s and other patients monitored by wireless sensors along the spine, likewise reported “important changes in clinical outcomes” — although “mixed results” were also found, the investigators said.

Wearable biosensors — noninvasive devices that couple data to the internet or a mobile app for self-monitoring or health assessment — have grown increasingly popular as wristbands or watches that do things like count steps or track sleep. However, overall proof that these sensors are improving patient outcomes across a range of ills, especially in regards to weight loss or lower blood pressure, is not there yet, the researchers said.

The study “Impact of remote patient monitoring on clinical outcomes: an updated meta-analysis of randomized controlled trials,” was published in npj Digital Medicine.

“As of now, we don’t have enough evidence that they consistently change clinical outcomes in a meaningful way,” Brennan Spiegel, MD, senior author of the study, said in a Cedars-Sinai release. “But that doesn’t mean they can’t.”

Wearable devices to measure health indicators are seen as a potential way to reduce healthcare burden, lower costs, generate data, and improve physician oversight. But a meta-analysis (considered a high-level analysis) revealed that remote patient monitoring showed no signs of significance in six clinical outcomes — healthy changes in body mass index, weight, waist circumference, body fat percentage, systolic blood pressure, and diastolic blood pressure.

This meta-review examined 27 studies from 13 countries, published between January 2000 and October 2016, that looked at the outcomes of patients with illnesses including cardiovascular disease, lung disease, Parkinson’s, and sleeping disorders. Devices ranged from physical activity trackers to pulse oximeters (oxygen saturation monitors) and were embedded in every available form, from watches to textiles.

The team’s analysis showed that the devices largely had no significant impact on outcomes studied, especially in the meta-analysis. Certain types of interventions worked best instead, they found, including efforts grounded in social science models and established care guidelines or personalized coaching.

“There is a big difference between using these sensors to track sleep for self-betterment and using them to make medical decisions,” said Michelle S. Keller, a study co-author.

Lack of available long-term and quality data could be a reason for these findings, the researchers emphasized. Very few studies were randomized and many varied significantly in terms of the types of devices used, populations observed, and interventions tested.

“Many of the studies we reviewed were still in the pilot phase,” said Benjamin Noah, the study’s lead author. “There just is not enough data yet.”

 

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Source: Parkinson's News Today