Article In Brief
In a small trial, Parkinson's disease patients wore a watch-like device that sent data remotely indicating the progression of motor fluctuations.
A watch-like device worn by Parkinson's disease (PD) patients was able to successfully monitor abnormal movements, including dyskinesias, and link them to the timing of their medications, according to a study published in the August issue of Functional Neurology.
The tool—the Personal KinetiGraph (PKG)—has received regulatory clearance through the US Food and Drug Administration in the US and may help clinicians get a better sense of when to adjust medications, or whether other treatment options are in order.
In a small trial, 60 PD patients wore the wearable motion tracker on one wrist for six days. During the same period, they also filled out a 48-hour motor diary. The scientists wanted to see whether the PKG algorithms to detect when medication was wearing off and when dyskinesia was present could help them assess progression of the disease. They also wanted to determine when levodopa therapy needed to be adjusted or was no longer working well enough and alternative treatment was warranted.
“Patients have a hard time labeling a motor fluctuation and it is often impossible to make sound medication management decisions based on a clinical encounter every three months,” said Michele Tagliati, MD, FAAN, director of the Movement Disorders Center at Cedar-Sinai Medical Center in Los Angeles, who along with colleagues tested the device in 60 patients.
“There is a tremendous need to figure out how to monitor these fluctuations and obtain objective data independent of their recollection or even motor diaries,” he said. “The device gives us a fairly accurate idea of their mobility fluctuations as it relates to the timing of their medication.”
“It is becoming a reality that we can monitor things remotely. The question is: How do we use the data practically and not be overwhelmed by it.”—DR. MICHAEL S. OKUN
Study Design, Findings
The PKG device is a motion sensor that can also be scheduled to sound a reminder for medications, Dr. Tagliati explained. Patients indicate when they take their medicine with a swipe across the screen. The information collected is analyzed via an online algorithm, which offers qualitative and quantitative data on the range of symptom control and motor fluctuations throughout the day.
The scientists at Cedar-Sinai Medical Center in Los Angeles used two clinically validated screening tools—the Wearing Off questionnaire and the Unified Parkinson's Disease Rating Scale–to separate study participants into groups: non-fluctuators, early, moderate, and troublesome fluctuators.
The device recorded data every two minutes and the algorithm printed out a sheet of data that included collected bradykinesia scores, dyskinesia scores, and fluctuation scores. Six patients were excluded from the analysis because of incomplete PKG data.
The device fluctuation score helped distinguish dyskinetic and non-dyskinetic patients and between some of the subgroups of fluctuators but was unable to provide a more consistent and granular degree of separation between those with mild to moderate to severe fluctuations.
The researchers did have to make adjustments with the information collected on the device. They observed a lot of continuous motor movements in some patients and they determined that it was due to exercising. The device saw it as dyskinesias, and they had to correct for that. (If the abnormal movement lasted for longer than 30-minutes they assumed it was related to exercise.)
The study results also aligned with what clinicians know about the standard motor diaries. Patients are not very good at determining abnormal movements and often forgot or skipped making note of them, Dr. Tagliati said, noting that patients did not take off the watch-like device (unless showering) and reported that it was a positive experience.
“People tend to tell the doctor that they are well even when they are not. And when they are not doing well, due to the day-to-day variability of their fluctuations, it is difficult to finely adjust their medications. The PKG device gives us information we just didn't have before,” he added. “Patients like wearable devices and this is a viable way to provide information that was completely lacking.”
“This is definitely the future of clinical monitoring, as well as clinical trial monitoring,” Dr. Tagliati continued. “This type of tool can give us a good indication of what we may need to do to make effective and timely adjustments to treatments. It is a winning concept. It offers us objective data to begin to understand what is going on in their daily lives.”
“There is a tremendous need to figure out how to monitor these fluctuations and obtain objective data independent of their recollection or even motor diaries. The device gives us a fairly accurate idea of their mobility fluctuations as it relates to the timing of their medication.”
—DR. MICHELE TAGLIATI
Expert Commentary
“This is a great example of the potential for digital tools to generate objective, sensitive and frequent assessments of how people with Parkinson's disease function in real world settings,” said E. Ray Dorsey, MD, MBA, the David M. Levy professor of neurology and director of the Center for Health and Technology at the University of Rochester. “This information from this study is a step in the right direction. We usually only get subjective assessments from our patients. These wearable sensors are valuable in making objective assessments. The information may help patients gain more control of their symptoms and may ultimately help physicians personalize the care of their patients.”
“This type of technology is very exciting,” added Michael S. Okun, MD, FAAN, the Adelaide Lackner professor and chair of neurology and executive director of the Norman Fixel Institute for Neurological Diseases at University of Florida Health. “It is becoming a reality that we can monitor things remotely. The question is: How do we use the data practically and not be overwhelmed by it?”
“If you have patients fluctuating a lot throughout the day it may be an indication that they are wearing off their medication sooner,” said his colleague Christopher W. Hess, MD, assistant professor of neurology and director of neurotechnology at University of Florida Health. The fluctuation score combines the variability in the dyskinesia score (involuntary abnormal movements) and the bradykinesia score (slowed movements.)
Dr. Hess uses several wearable devices to gather objective data, including PKG. He is part of the APPRISE study that is designed to test the role of wearables in the clinical management of PD patients and how it affects physician decision making.
“If the fluctuation score is low and bradykinesia score is high all the time it may be that the patient is not getting enough levodopa. The algorithm gives us more information about what is going on.”
Dr. Hess said that one drawback is that it is only providing motor measurement of one upper limb and patients can have dyskinesias and bradykinesias all over. “But it's a middle ground that is convenient and accurate,” he said.
“There is a definite need to have reliable objective measurements to see the degree of complications,” he added. “This is a challenging thing to do.”
He believes that these types of devices will become commonplace in the future. “Patients also become more engaged in their care, he said. The device reminds patients to take their medication at specific times.
Disclosures
Dr. Tagliati has received consulting fees from Abbott as well as consulting fees and speaker honoraria from Boston Scientific and Medtronic. Dr. Michelson receives royalty payments from UpToDate. Dr. Dorsey has received consulting fees from 23andMe, Abbott, Abbie, American Well, Biogen, Clintrex, DecBio, Denale Therapeutics, GlaxoSmithKline, Grand Rounds, Karger, Lundbeck, MC10, MedAvante, Medical-legal services, Mednick Associates, National Institute of Neurological Disorders and Stroke, Olson Research Group, Optio, Origent Data Sciences, Inc., Prilenia, Putnam Associates, Roche, Sanofi, Shire, Sunovion Pharna, Teva, UCB, and Voyager Therapeutics. He has ownership interest in Blackfynn and Grand Rounds. Dr. Hess serves as a consultant to the Michael J. Fox Foundation for Research and sometimes is reimbursed for travel in that role; receives royalties as a peer reviewer for UpToDate; and has received travel and honoraria fees as a speaker for the National Parkinson Foundation, the Parkinson's Disease Foundation, and the Davis Phinney Foundation.
https://journals.lww.com/neurotodayonline/Fulltext/2019/08220/How_a_Watch_Like_Device_Is_Monitoring_Parkinson_s.8.aspx
No comments:
Post a Comment