Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Thursday, December 5, 2024

Wearable Devices for Parkinson’s Disease: The Future Is Here

 If your competent? doctor can't see that these could provide an objective damage diagnosis of your gait problems leading to EXACT PROTOCOLS to fix those gait problems. Then you DON'T have a functioning stroke doctor! RUN AWAY!

Wearable Devices for Parkinson’s Disease: The Future Is Here

Less than a decade ago, the use of wearable devices in Parkinson’s disease (PD) was considered futuristic. Today, there’s an array of innovative tools from commercial activity trackers to tremor suppression gloves and laser-guided walking sticks to help manage the highly variable and fluctuating symptoms of PD.

“Over the past 5 years, the landscape of wearable technology for Parkinson’s monitoring has transformed remarkably,” Roongroj Bhidayasiri, MD, co-chair of the International Parkinson and Movement Disorder Society’s (MDS’s) Technology Study Group, told Medscape Medical News.

Advances in sensor technology, data analytics, and machine learning have significantly enhanced the precision and usability of wearable devices, he noted. They now offer continuous, real-time monitoring of both motor and nonmotor symptoms, which supports personalized treatment plans and more accurate tracking of disease progression.

Additionally, the integration of artificial intelligence analytics facilitates more comprehensive data analysis, whereas integration with mobile applications enhances patient engagement and data sharing with providers, said Bhidayasiri, director, Chulalongkorn Center of Excellence for Parkinson’s Disease & Related Disorders, and professor of neurology, Chulalongkorn University, Bangkok, Thailand.

“These technological advancements have cemented wearables as invaluable tools in the efficient and responsive management of PD within neurology care models,” he added.

Andrea Pilotto, MD, fellow MDS Technology Study Group co-chair and associate professor of neurology, University of Brescia, Brescia, Italy, pointed out that recent advances have improved the ability to capture subtle motor deficits that appear years before a clinical diagnosis of PD and add granularity to office assessments and patient home diaries.

“For sure, patient-reported outcomes are important, but we know that a large percentage of patients, especially with motor fluctuations, are not clearly aware of their symptoms or misjudge their symptoms,” he said in an interview.

The focus of wearable sensors is also shifting from its hallmark motor symptoms to monitoring nonmotor features of PD, which can vary throughout the day and influence motor measurements and therapeutic choices.

“We are now realizing the potential of wearables to begin to address anxiety, sleep, depression, and other nonmotor symptoms,” Michael S. Okun, MD, medical advisor, Parkinson’s Foundation, and director, Norman Fixel Institute for Neurological Diseases, University of Florida Health, Gainesville, Florida, told Medscape Medical News.

“This could be a game changer as nonmotor symptoms in many studies are more important than the motor symptoms in impacting quality of life,” he added.

Tracking Symptoms

Smartwatches with embedded accelerometers and gyroscopes took off during the COVID-19 pandemic as consumers sought real-time feedback on their mobility, sleep, and heart rate. The pivotal WATCH-PD study and US Food and Drug Administration (FDA) clearance of the Apple Watch–based StrivePD application in 2022 helped drive the use of wearables to monitor PD symptoms.

StrivePD (Rune Labs, Inc.; San Francisco) passively collects daily data on tremor and dyskinesia using Apple’s Movement Disorder Application Programming Interface and lets patients log items such as symptoms, medications, side effects, mood, and sleep. Patients can view summary reports in the app or via email, and a clinician dashboard provides summaries of symptoms, medication use, and self-reported data.

“The Apple Watch is certainly quite accessible, that’s one advantage, and StrivePD is probably the one [app] that my patients are most familiar with and are accessing, using, and getting reports from,” Joohi Jimenez-Shahed, MD, medical director, Movement Disorders Neuromodulation and Brain Circuit Therapeutics, and associate professor of neurology, Icahn School of Medicine at Mount Sinai, New York City, told Medscape Medical News.

The American Parkinson Disease Association has its own free symptom tracker, available in English and Spanish, that is designed for the iPhone and records motor and nonmotor symptoms, has an interactive medication tracker, and creates reports to share with the patient’s care team.

The French NS-Park research network’s wearable sensors workgroup, in partnership with the Parkinson’s Foundation, recently published a “practical anthology” summarizing the characteristics of the most used wearable sensors for PD management in Europe — most of which are also available in the United States.

It provides a deep dive into the PDMonitor, Personal KinetiGraph (PKG), STAT-ON, Kinesia 360/One, FeetMe, and Mobility Lab, which is not available in Europe. Notably, the Kinesia 360/KinesiaU, PDMonitor, PKG, and STAT-ON devices are “conditionally recommended as options” in the 2023 National Institute for Health and Care Excellence diagnostics guidance on wearables for remote PD monitoring.

Tremor Suppression

Tremors are present in about 80% of patients with PD and can affect activities of daily living and mental health. Launched in June 2023, the Cala kIQ system (Cala Health, Inc.; San Mateo, California) is the first FDA-cleared device for temporary postural and kinetic hand tremor relief in PD as well as essential tremor.

The wrist-worn, physician-prescribed device delivers transcutaneous afferent patterned stimulation, which improved symptoms in 92% of patients with essential tremor when used twice daily over 3 months in a prospective study cited by the company.

The initial out-of-pocket cost for the Cala system is $7150, which is covered for Medicare beneficiaries and veterans with essential tremor but not by commercial insurance plans.

“Getting that out to patients has been difficult, not for a lack of trying certainly on my part,” said Jimenez-Shahed, who is also co-chair of the Parkinson Study Group. “It’s been a challenge to get it covered, and out-of-pocket costs are, quite frankly, for a lot of people just not doable or they’re not willing to spend that kind of money on something they’re not sure how much it’s going to work.”

Several tremor suppression gloves, or PD gloves, are widely available and promise to stabilize hand movements through peripheral stimulation. Additionally, devices like Microsoft’s Emma Watch, which is in the research stage only, use vibration therapy to counteract tremor effects.

Improving Gait

To improve gait, wearable systems equipped with inertial measurement units help analyze and provide feedback on walking patterns, facilitating better mobility through targeted interventions, said Bhidayasiri, who along with other experts interviewed for this article declined to comment on specific devices.

PD shoes with embedded cueing devices can provide visual cueing for freezing of gait (FoG), he said. Alternatively, these shoes can be equipped with devices that provide vibratory and proprioceptive stimulation, shown to improve FoG.

“Parkinson’s shoes with embedded cueing devices represent emerging technologies and may not yet be widely available in all clinical settings,” Bhidayasiri noted.

The French anthology details the FeetMe Monitor insoles (FeetMe; Paris, France), which use embedded pressure sensors and algorithms to compute spatiotemporal gait parameters and collect them through a dedicated mobile application. Clinical data are limited, but results from the sole validation study in PD show very high correlations and good agreement between the FeetMe insoles and an electronic pressure-sensitive walkway.

The anthology also weighs in on Mobility Lab (Clario, Philadelphia), a portable system developed by APDM (Portland, Oregon) that measures gait, postural balance, and arm swing using one to six wireless wearable sensors. It is described as one of the best validated tools in terms of study number for gait and postural in-hospital analysis but is mainly used for in-hospital assessment.

“Many things have been tried, but I have not yet seen one come to market dominance or be so clearly effective that we are recommending it to patients,” Miriam Rafferty, PT, DPT, PhD, director of Implementation Science and research scientist, Shirley Ryan AbilityLab, and assistant professor, Northwestern University, both in Chicago, told Medscape Medical News.

“At Shirley Ryan AbilityLab, one of the efforts that our patients are driving is to have a kind of technology trial clinic so that we can have versions of a lot of the devices here so patients can try them,” she added. “It’s very daunting to think I could buy this pair of shoes that going to cost $1500 and it may or may not work for me.”

Voice changes affect about 70%-90% of patients with PD, making it difficult to be heard or understood particularly as the disease progresses.

SpeechVive is a behind-the-ear device that plays a “babble” noise in one ear during speech, leveraging the Lombard effect or the brain’s automatic response to speak louder as ambient sounds increase.

It boosts conversation volume by approximately 50% and provided similar benefits as LSVT LOUD speech therapy in a prospective study of 18 patients with PD. It is covered by Medicare, according to the SpeechVive company.

Jimenez-Shahed said she sends a lot of patients to speech therapy and doesn’t prescribe the SpeechVive very much. “When it first came out, patients were trying it and some of the feedback I got is that there’s this background noise you hear, so it was a little difficult for some patients. It does take a little getting used to.”

The Road Ahead

While wearables have many strengths, experts note several limitations exist, including patient adherence, which can affect data reliability; privacy concerns; devices may not capture the full spectrum of PD symptoms, especially nonmotor symptoms; and a lack of national or international guidelines on how best to use the devices and their scope of use.

The MDS Technology Study Group is in the process of surveying the society’s more than 11,000 members to see how wearables are being used, which patients with PD should be tracked, insurance or healthcare system coverage for devices, and pragmatic limitations from the patient/caregiver and clinician/institution viewpoint, Pilotto said.

“We put some clinical scenarios in the survey to see how clinicians are reacting and if they are prepared or if they would use technology and which kind of technology in different scenarios,” he said.

Pilotto noted that two other MDS projects are underway: A consensus document characterizing the use of wearable technology in clinical trials and a review of digital devices in the clinic based on published longitudinal, prospective trial evidence.

Other challenges for wearables are the lack of standardized outcome measures validated for longitudinal assessment, lack of direct comparisons between devices, cost effectiveness, and, importantly, the effect on treatment modifications and PD management.

“One of the biggest challenges for wearables has been whether the juice is worth the squeeze. Does the information provided move the needle enough to motivate folks to use them,” said Okun, with the Parkinson’s Foundation.

Rafferty told Medscape Medical News that data management is one of the biggest challenges with the increasing number of devices used by and marketed to patients. The Shirley Ryan AbilityLab contracted with a software platform that can take data from any commercially available device, so patients can share it with their physical therapist and help set goals for therapy. “We call it a bring-your-own-device strategy.”

Commenting further, Rafferty said, “I have heard from patients that when they share their technology with their neurologists, the neurologists are like, ‘That’s nice,’ but that the neurologists aren’t always driving that conversation.”

Clinicians are very busy in their day-to-day clinical practice, so unless the device is very intuitive, easy to use, and their organization already has a contract with it, then the clinician is going to be limited in their conversations that they can initiate with a patient, she explained.

Part of her team’s work is to help researchers at Shirley Ryan AbilityLab develop dashboards that clinicians want, with the metrics they need, by gathering their feedback early in the development process.

“The last thing you want is for a really busy clinician to open a dashboard and then not be able to find the information they want to know quickly and easily,” Rafferty said.

Bhidayasiri reported receiving grants from Thailand Science, Research and Innovation; Chulalongkorn University; and the Royal Society of Thailand. He reported receiving consultancy fees, honoraria, and lecture fees from Britannia, Ipsen, Teva-Lundbeck, and Mitsubishi Tanabe; patents for a laser-guided walking stick, portable tremor device, technology for nocturnal monitoring, electronic symptom diary, a PD insole and shoe, and anti-choking mugs; and copyrights for various PD-related works.

Pilotto reported receiving grants from the Airalzh Foundation, Italian Society of Parkinson and Movement Disorders Foundation, Italian Ministry of University and Research, and Italian Ministry of Health.

Okun reported having no relevant conflicts of interest.

Rafferty reported receiving funding from the National Institutes of Health; the Agency for Healthcare Research and Quality; and the National Institute on Disability, Independent Living, and Rehabilitation Research.

Jimenez-Shahed reported receiving consulting fees and an educational grant from Medtronic; serving on the data safety monitoring board for BlueRock Therapeutics and Emalex; serving on the clinical and scientific advisory board for PhotoPharmics; and receiving consulting fees from Bracket/Syneos, Teva, AbbVie, Alpha Omega, REGENXBIO, Praxis, Kyowa Kirin, TreeFrog, and Amneal. She is also co-chair of the Parkinson Study Group.

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