Parkinson's

Wearable Technology

Wearables For Parkinson’s Management

The Parkinson’s Solution Summit 2.0

https://drive.google.com/file/d/1Ir3zSkFYGO4KB3sPyrhHoSSKLd75EBA8/view?usp=drive_link

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">Thanks, Barbara. I appreciate you having me.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">Thank you. I think our viewers would be curious about what some of the challenges are that they face and the health care providers, their health care providers face when managing therapy for Parkinson's disease. Can you tell me about some of those challenges from your point of view?</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">As you and the viewers well know, Parkinson's disease is extremely complex. Symptoms fluctuate weight throughout the day. They can fluctuate across days, and every patient responds differently to therapy. When the patient visits their doctor, it could be a good or a bad day. It could be a good time or a bad time. The patient's partner or caregiver may say, wait a minute, they're not like that at home. Sometimes patients will perform better when they're at the clinic. It can be very difficult for the doctor to get a clear picture of how a patient is responding to their treatment. They may only see their neurologist once or twice a year. During that snapshot, it's very difficult to get a true picture of how they're doing at home during their daily activities. Then if the doctor recommends a change in therapy or a change in dosing, it could be a long time before they're seen at the clinic again. It could take a long trial-and-error process to get the medication just right. In the meantime, they're not responding as well as they could be. That could be a better treatment, better therapy, or a better therapy schedule that works better for them. The doctor doesn't know this until they see him during one of these infrequent visits.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">A lot of good points that you brought up there. The motivation sometimes in the clinic—indeed, we as health care providers see that patients seem to outperform or, as opposed to what is being told to us by, their caregivers. Very important. How would your solution look, and how was it developed?</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">Sure. Going back 20 years, we have done several clinical studies to develop wearable systems for monitoring Parkinson's disease symptoms throughout the day. We used an accelerometer and gyroscope. These are motion sensors that measure acceleration and angular velocity. In the early 2000s, that's when the Nintendo Wii came out. These motion sensors became much more commonplace, so we were able to develop a system that uses these to quantify Parkinson's symptoms. To do this, we performed several studies; we had patients come into the clinic, go into the doctor's office, and come into our office. Where are these motion sensors on various parts of the body and perform various motor assessment tasks that are similar to what they would do in the clinic during a clinical assessment? Some of you may have heard of the Unified Parkinson's Disease Rating Scale. This is one of the common assessment scales that clinicians will use during a clinical visit. It has items such as having the patients tap their fingers, hold their arms out, and so on to evaluate different aspects of the disease. This is evaluating things like different types of tremor or bradykinin show or slowness. These various activities we had patients perform while wearing our motion sensors. We had them do these both when they were on their medication and off their medication, to get a wide variety of symptoms from hundreds of patients. We videotaped them while they were performing these assessments and then had clinicians rate them, as they would do during a standard clinical assessment. Then we did various analyses on the motion data to extract features and the motion data that best represented their symptoms. We then used the scores given by clinicians combined with the data from the motion sensors we collected to develop machine learning algorithms. These are algorithms now that use motion data to rate symptoms, just like a clinician would during a clinical visit. Now, doctors can't be with you all the time. They can't be following you 24 seven. This allows for additional information. We started with this task-based assessment similar to what patients do in the clinic. This is mainly used for clinical trials to provide an objective outcome measure to see if the therapy was working or not or was effective or not. Pharmaceutical companies and device companies would use this as part of their therapy evaluation to get FDA approval to see if the therapy was working. This goes back to 2007 when we first got our first system was first cleared for market by the FDA.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">That's very interesting. Does the system also account for postural instability?</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">Right now, our commercial system doesn't measure postural instability, specifically. Some systems do that. That's something we may want to add. We're getting more into some of the additional systems, symptoms, and activities every day. We started with this task-based assessment and then moved into continuous passive monitoring, where it's just something that a patient can wear all day and during their activities of daily living. We're currently evaluating things like tremor, slowness, and dyskinesia, as dyskinesias are a side effect of over-medication.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">Very interesting! Very important work. Have you heard from clinicians how your technologies are helping patients clinically?</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">While we started being used primarily for research, we have more recently been moving into using these to help with clinical care. As I mentioned, symptoms fluctuate throughout the day. What happened was a lot of the people who participated in these research studies versus systems where you said, wait a minute, I want to keep using this. I want my doctor to see how I'm doing. I want to be able to see this. I want to be able to track it. We've done a few things to help. Make this more applicable and useful in the clinic as well as improve the use for patients. One example is when we started by making our proprietary sensor, now that smartwatches are so commonplace. Instead of having to manufacture our sensors, accelerometers, and gyroscopes, we can use the accelerometers and gyroscopes that are in common in Smartwatches like the Apple Watch, the Samsung, and the Google Watch, and then use that motion data with our validated algorithm. These are our algorithms still. We're just using the wearable, the Smartwatch, to collect the motion data to evaluate symptoms throughout the day. We've done several studies where doctors have used this information to help with remotely monitoring their patients and adjusting their therapy remotely. When the patient wears the system at home, they can see on their phone how they're doing, which helps keep them engaged. But then all of this also gets sent remotely to their doctor's office so the doctor can check in on them and see how they're responding. This way, patients can get optimized faster. They can get on a better therapy regimen without having to come back and forth repeatedly times to the clinic. Then also if the disease progresses or if a patient's not responding as well, doctors can see that remotely and determine if an adjustment is needed. Every patient responds differently to medication. With this, it's much easier. It helps to determine a more personalized schedule specific to each patient.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">Yes. That's why it's extremely important to individualize the therapy. It's an ongoing process, to individualize it dynamically, moving forward actively, and to have that information stored and also to be able to look back—I'm assuming that—that there's data collected that we can look back at past therapies for that particular person and analyze that. Is that the case? Is there history that we can do?</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">Everything's stored in a database so that doctors can look back on this. Some other things that they're using this for are seeing symptoms progress. If they worsen determine when someone might be ready for an advanced therapy such as deep brain stimulation or a drug pump.</span>

<span style="font-weight: 400;">We've done studies showing that when patients are monitored remotely, doctors are more likely to recommend them for advanced therapy than if they weren't. Patients have expressed they're more confident in their therapy when they know that their doctors can track them and see how they're doing over time.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">Indeed. You mentioned a benefit to patients that they can track. Are there any other benefits to patients that you've come across?</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">It helps keep them engaged. Everyone I've talked to with Parkinson's are engaged, they're they want to know about what the latest treatments are. They want to be able to see how they're doing, and when patients can see and track their symptoms over time, it helps keep them engaged. They're more likely to continue with their therapy. They're more confident in therapy. Again, if they know that their doctor is going to be monitoring them, they're more likely to want to try something new.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">I'm assuming it would have an impact on compliance as well. Following the drug schedule as prescribed is finding that that's the case.</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">We've done studies that even showed when patients can see their symptoms, can see when they're starting a new therapy, how their symptoms are gradually starting to improve, that they're more confident that some new therapies can cause temporary side effects like nausea. But when patients see that they're starting to improve, they're more likely to persist with this. And that continues with it to get the benefit of that therapy.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">It's very interesting. Thank you. How would you envision your technology being used in the future? Give us a peek behind the screen.</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">We envision this being a part of precision medicine, where this can help determine personalized schedules. Again, as each patient responds differently, it shouldn't be that each patient has the same dose of medication every four hours. You could have very individualized dosing that this could help automatically determine. By using artificial intelligence algorithms with this information, it could help determine an individualized dose regimen for a specific patient. Additionally, it will be able to detect things like when symptoms wear off, and if they're wearing off before the next scheduled dose, maybe it can notify them that it's time to either take their medication or try a rescue medication. Before it's time to take their next scheduled dose. Then also something we're working on is a lot of therapies, such as deep brain stimulation and drug pumps that are provided continuously. These need to be adjusted over time. Symptoms may vary with activity. We're working to close the loop where our sensors can measure symptoms and then adjust therapy accordingly in real-time. With this type of wearable sensor, patients could have therapy that responds and adjusts specifically to what they're doing and how their symptoms are at that specific time.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">That's the future. That's where we're going. That's very interesting. I'm assuming that the data that you collect is protected information under HIPAA.</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">Both HIPAA and GDPR, we're also on the market in Europe as well as the US.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">Wonderful. How long have you been in Europe with your tech?</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">Back in 2007, we first got approved in the US, and then I think it was in 2009 that we received our C mark and started in Europe. 2009, 2010, somewhere around somewhere around there. It's been a while.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">In the function of clinical studies at that time.</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">Primarily for research use, although our latest product, the one targeted towards consumers, is called kidneys. Are you the one who uses the Smartwatch that's only come out in the last few years as smartwatches become common? First in the US, maybe, I'm trying to remember in the last few years, and then a little bit more recently in Europe. But we're cleared for sale in the US, Canada, EU, UK, and Australia currently.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">Wonderful. How can patients get more information about this and/or health care providers? How can they find you?</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">I would encourage them to visit our website, www.kinesiau.com for the product.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">That's www.kinesiau.com</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">KINESIA, the letter U dot com Our company is Great Lakes Neurotechnologies, glneurotech.com. I will say that in the US the system does require a prescription. I would encourage you to talk to your doctor about it. Anyone can download the app from the Apple App Store, but it'll just be a demo until we receive a prescription.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">Understood. Very interesting. I want to thank you very much. I think this has brought a new perspective to many people, and people curious can find more information about it. It is available in the States on prescription. And people can talk to their healthcare providers about the Great Lakes Neurotechnology at kinesiau.com. They can look that up. Dustin, I'm curious, how much does this cost people to have such a wearable?</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">One of the reasons we moved from making our sensors to going to the common consumer Smartwatches was to keep costs low. If you already have a compatible Smartwatch like the Apple Watch, like the Google Pixel or Samsung Galaxy Watch, there's no additional hardware to buy. This is the standard watch that you can get commercially, and it's just an app that you're downloading. We are not charging patients at this time to install the app or to use it; rather, it's on the clinician's side. Doctors can access your data remotely through our portal. Instead, we bill the doctors for access to the data. Then doctors can bill your insurance under remote patient monitoring billing codes for their time spent reviewing the data. For you using this remotely and for discussing the data with you. We're not charging anything to patients directly. Again, doctors will be able to bill for their time spent reviewing the data and discussing it with you and then our businesses between are at the clinical offices.</span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">I see. Thank you very much. That's very interesting. Thank you so much for being with us today. I've learned a lot, and I appreciate your time.</span>

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<h6><b>Dustin Heldman, PhD</b></h6>
<span style="font-weight: 400;">Thank you. Barbara, I appreciate the time as well. </span>

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<h6><b>Barbara Pickut, MD, MPH</b></h6>
<span style="font-weight: 400;">Hello, everyone, and welcome to the Parkinson’s Solution Summit 2.0. I'm your co-host, Dr. Barbara Pickut. In Parkinson's disease, from a clinical perspective, effectively managing motor symptoms and their complications requires regular and thorough monitoring of how these symptoms evolve. By consistently tracking symptom progression, healthcare providers can gain valuable insights into the patient's condition. This ongoing observation is crucial because it allows the healthcare provider to facilitate discussions with the patient about these treatment decisions, adjust medications appropriately, and implement interventions that can significantly improve a patient's quality of life. Regular monitoring helps identify patterns, predict potential complications, and create customized treatment plans to meet the unique needs of each person, with Parkinson's ultimately leading to more effective and personalized care. Today, we'll speak with Dr. Dustin Heldman on wearables and their applications for Parkinson's disease. Dustin Heldman is the President and Chief Operating Officer at Great Lakes Neuro Technologies, which is located in Cleveland, Ohio. He received his bachelor's degree from Duke University and his PhD in 2007 from Washington University, both in biomedical engineering at Great Lakes Neuro Technologies. Dr. Heldman is currently leading a team of researchers and engineers in the development, clinical evaluation, and commercialization of next-generation movement analysis systems. Dr. Heldman has served as Principal Investigator on 12 grants funded by the National Institutes of Health. Dr. Heldman is an inventor on 46 awarded U.S. patents. Welcome, Dr. Heldman. Welcome, Dustin.</span>

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<p>Dustin Heldman is the President and Chief Operating Officer at Great Lakes NeuroTechnologies. He received his B.S. degree from Duke University, followed by his Ph.D. from Washington University in St. Louis, both in Biomedical Engineering. He joined Cleveland Medical Devices in 2007 as the senior biomedical engineering researcher, where he focused on the development and clinical validation of machine learning algorithms for quantifying movement disorder motor symptoms, which are now part of the Kinesia motor assessment systems. In 2010, Dr. Heldman became the first employee at Great Lakes NeuroTechnologies when the movement disorder division of Cleveland Medical Devices was spun off into its own company. At Great Lakes NeuroTechnologies, he has continued to lead the research team in executing clinical studies, algorithm development, and statistical analysis, as Biomedical Research Manager starting in 2010 and Biomedical Research Director starting in 2016. In 2018, Dr. Heldman became President and COO of Great Lakes NeuroTechnologies, a role he still holds today. Dr. Heldman has served as principal investigator on eight Phase 1 and four Phase 2 SBIR grants funded by the National Institutes of Health and is inventor on 46 awarded US patents. He is currently leading a team of researchers and engineers in the development, clinical evaluation, and commercialization of the next generation of movement analysis systems.</p>


Dustin Heldman

Dustin Heldman, PhD

<p>Dr. Barbara Anne Pickut, MD, MPH, is a Neurologist and Movement Disorders specialist with profound expertise in Parkinson&#8217;s disease and mindfulness-based training as a non-pharmacological intervention to enhance wellness for People with Parkinson&#8217;s and their Care Partners. She has an extensive background in clinical research for Parkinson&#8217;s, having been an investigator in multiple international new drug development trials.</p>
<p>Dr. Pickut&#8217;s ground-breaking research has demonstrated the benefits of mindfulness-based training in reducing Parkinson&#8217;s disease symptoms, showing measurable changes on MRI brain scans and improvements in quality of life. Her latest research involves a focus group analysis of the lived experiences of people with Parkinson&#8217;s after an 8-week mindfulness training.</p>
<p>Dr. Pickut is a certified teacher of mindfulness-based stress reduction (MBSR) from the University of Massachusetts Center for Mindfulness and a certified yoga instructor.</p>
<p>Contact: barbara@parkinsonsmindfulness.com</p>


Wearables For Parkinson’s Management

Barbara Pickut, MD, MPH

Dustin Heldman, PhD

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Barbara Pickut, MD, MPH

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Dustin Heldman, PhD