Zeit’s early warning wearable for sleep strokes could save hours and lives

Those at risk are always vigilant for the signs of a stroke in progress, but no one can be vigilant when they’re sleeping, meaning thousands of people suffer “wake-up strokes” that are only identified hours after the fact. Zeit Medical’s brain-monitoring wearable could help raise the alarm and get people to the hospital fast enough to mitigate the stroke’s damage and potentially save lives.

A few decades ago, there wasn’t much anyone could do to help a stroke victim. But an effective medication entered use in the ’90s, and a little later a surgical procedure was also pioneered — but both need to be administered within a few hours of the stroke’s onset.

Orestis Vardoulis and Urs Naber started Zeit (“time”) after seeing the resources being put towards reducing the delay between a 911 call regarding a stroke and the victim getting the therapy needed. The company is part of Y Combinator’s Summer 2021 cohort.

“It used to be that you couldn’t do anything, but suddenly it really mattered how fast you got to the hospital,” said Naber. “As soon as the stroke hits you, your brain starts dying, so time is the most crucial thing. People have spent millions shrinking the time between the 911 call and transport, and from the hospital door to treatment. but no one is addressing those hours that happen before the 911 call — so we realized that’s where we need to innovate.”

If only the stroke could be identified before the person even realizes it’s happening, they and others could be alerted and off to the hospital long before an ambulance would normally be called. As it turns out, there’s another situation where this needs to happen: in the OR.

For illustrative purposes, an EEG signal that changes its character can be detected quickly by the algorithm.

Surgeons and nurses performing operations obviously monitor the patient’s vitals closely, and have learned to identify the signs of an impending stroke from the EEG monitoring their brainwaves.

“There are specific patterns that people are trained to catch with their eyes. We learned from the best neurologists out there how they process this data visually, and we built a tool to detect that automatically,” said Vardoulis. “This clinical experience really helped, because they assisted in defining features within the signal that helped us accelerate the process of deciding what is important and what is not.”

The team created a soft, wearable headband with a compact EEG built in that monitors the relevant signals from the brain. This data is sent to a smartphone app for analysis by a machine learning model trained on the aforementioned patterns, and if anything is detected, an alarm is sent to the user and pre-specified caregivers. It can also be set to automatically call 911.

“The vast majority of the data we have analyzed comes out of the OR,” said Vardoulis, where it can immediately be checked against the ground truth. “We saw that we have an algorithm that can robustly capture the onset of events in the OR with zero false positives.”

That should translate well to the home, they say, where there are actually fewer complicating variables. To test that, they’re working with a group of high-risk people who have already had one stroke; the months immediately following a stroke or related event (there are various clinically differentiated categories) is a dangerous one when second events are common.

Orestis Vardoulis, left, and Urs Naber, co-founders of Zeit, pose with each other in a courtyard.

Image Credits: Zeit

“Right now we have a research kit that we’re shipping to individuals involved in our studies that has the headband and phone. Users are wearing it every night,” said Vardoulis. “We’re preparing for a path that will allow us to go commercial at some point in 2023. We’re working with he FDA to define the clinical proof needed to get this clear.”

They’ve earned a “Breakthrough Device” classification, which (like stroke rehabilitation company BrainQ) puts them in position to move forward quickly with testing and certification.

“We’re going to start in the US, but we see a need globally,” said Naber. “There are countries where aging is even more prevalent and the support structure for disability care are even less.” The device could significantly lower the risk and cost of at-home and disability care for many people who might otherwise have to regularly visit the hospital.

The plan for now is to continue to gather data and partners until they can set up a large-scale study, which will almost certainly be required to move the device from direct-to-consumer to reimbursable (i.e. covered by insurance). And although they are totally focused on strokes for the present, the method could be adapted to watching for other neurological conditions.

“We hope to see a future where everyone with a stroke risk is issued this device,” said Vardoulis. “We really do see this as the missing puzzle piece in the stroke care continuum.”

#artificial-intelligence, #gadgets, #hardware, #health, #machine-learning, #medical, #medtech, #startups, #stroke, #strokes, #tc, #y-combinator, #zeit-medical

BrainQ raises $40M to transform stroke patient rehabilitation with its home therapy device

If you injure your elbow, surgery can help. If you lose a leg, prostheses are available. But problems within the brain are more difficult to treat, and for stroke victims rehabilitation is largely left to the body’s own repair mechanisms. BrainQ aims to change that with a device that stimulates the damaged part of the brain and promotes self-repair, showing enough improvement in studies to warrant a Breakthrough Device certification from the FDA — and the company has just raised $40M to take it to market.

It should be said at the outset that doubting the efficacy of some brainwave-emitting miracle device is natural. And in fact when I spoke with BrainQ’s founder Yotam Drechsler, he reminded me of the last time we’d talked — back in 2017, at which time I “expressed strong skepticism.”

No hard feelings — the tech was largely notional then, he admitted — but since that time the team has continued its work, raised some money, and what was a promising if not well supported thesis then has turned into one backed by firsthand data and clinical outcomes. The resulting system could be the biggest improvement to stroke therapy in decades or more.

Strokes can result in various obvious impairments, such as grip strength or coordination, but of course the injury is not to the hand or leg itself, it is to the networks in the brain that govern those parts. But medical science has no method for directly rebuilding those networks — the brain must do so on its own, in its own time.

To aid this, regular physical therapy and brain health checkups, sometimes for years on end, are used to in essence make sure the brain is still working on it and that the parts of the body don’t themselves fall into disrepair.

The most interesting improvements to this process in recent years have added tech into the loop to provide immediate feedback, such as that one’s balance is skewed to one side, and providing stimuli that aim to counteract that. But ultimately it’s still targeted physical therapy.

Drechsler and BrainQ see the problem a little differently. It’s not simply an injury but a disturbance to the brain’s carefully cultivated homeostasis, one which it has no means to counteract. He compared a stroke not to an analogous injury but to a baby born prematurely and whose body is not up to the task of heating itself. What do you do in such a case? You don’t attempt to “fix” the body so it can operate at lower temperatures, or supercharge the heat output — you just put the kid in an incubator, and everything proceeds as it should.

BrainQ’s device does something similar, making the brain operate better by changing its local environment.

“We map the channels of healthy brains and non-healthy brains and compare them. Once we find these, we use a low-intensity magnetic field therapy to resonate in the brain and facilitate its endogenous recovery mechanisms,” explained Drechsler.

It’s been shown in other contexts that this type of stimulation can produce improved neuroplasticity — the capability of the central nervous system to reprogram itself. By narrowly targeting stroke-affected areas, BrainQ’s device promotes neuroplasticity in them, leading to expedited recovery.

But it’s not simply a matter of saying “the stroke affected the ventral half of the right occipital lobe, aim the magnets there.” The brain is a complicated system, and strokes affect networks, not just a given cubic centimeter. BrainQ has deployed machine learning and a large collection of data to better understand how to target those networks.

Without diving too deeply into how the brain operates, let it suffice to say that certain networks operate locally at very specific spectral signatures or frequencies as detected by EEG readings. The left hand and left foot may occupy the same region of the motor cortex, but the hand might operate at 22 Hz, while the foot operates at 24 Hz, for example.

“The question is, how do you find these signatures?” asked Drechsler. As it’s somewhat difficult to explain, I asked him to put it in his own words after we spoke:

The novelty of BrainQ’s investigational treatment lies in the data-driven method we have deployed in order to inform the ELF-EMF frequency parameters. In choosing these parameters, our aim is to select frequencies that characterize motor-related neural networks in the CNS, and are related to the disability a person experiences following a stroke or other neurological trauma. To achieve this, we have analyzed a large-scale amount of healthy and non-healthy individuals’ brainwaves (electrophysiology data). Our technology uses explanatory machine learning algorithms to observe the natural spectral characteristics and derive unique therapeutic insights. These are used by BrainQ’s technology to target the recovery of impaired networks.

The device they’ve created to administer the treatment is unusual. Because it’s a whole-brain magnetic field generator, it has a rather bulky cylindrical headpiece , but the rest of it fits into a sort of back brace and hip pack. That’s because, unlike the more common magnetic brain imaging tech, MRI, the fields and currents involved are extremely small.

A man wears a BrainQ headset while sitting in a chair, while a woman operates a tablet near him.

Image Credits: BrainQ

“We use very, very low intensity, about the same level as normal brain activity,” said Drechsler. “It’s not about creating an action potential or a jump in activity, it’s about creating the right conditions for the recovery mechanisms.”

The results of this stimulation were borne out in a small (25 patients) but decisive study due to be reviewed and published soon (preprint abstract here). Patients given the BrainQ treatment in addition to normal therapy saw hugely improved recovery evaluations, which look at metrics like improvements to balance and strength. 92 percent saw major improvements over just therapy and 80 percent achieved what could be called recovery (though this term is inexact).

Generally speaking the therapy would last for about an hour at a time, during which the patient would do various physical exercises while wearing the device, and they would need to be repeated five days a week for two months or so. The headset feeds the patient’s own patterns into BrainQ’s cloud-based service, which does the crunching and matching necessary to produce a tailored treatment pattern. It’s all run via tablet app, which can be operated by a caregiver (such as an outpatient nurse) or by using a built-in telemedicine platform.

Drechsler said that this approach was poorly received early on, and not just by this reporter.

“In 2017, we started to set the ground for a cloud-connected therapeutic device that can treat the patient wherever she or he is,” he said. “Back then no one was willing to even talk about treating patients outside the controlled environment of the hospital. Then in 2020 COVID came and everything changed.”

He noted that during the pandemic, many of those recovering from a stroke who would normally visit the hospital for regular care were (and some remain) unable to do so. A home-based therapy with low risk and potentially great outcomes would be of enormous benefit for thousands and thousands of people currently recovering from a stroke. And importantly, he notes, it doesn’t shift resources away from existing treatment plans, just improves their outcomes. (“We don’t move anybody’s cheese.”)

Here is where you would normally read something along the lines of “but it maybe five years before the FDA approves it for insurance and use.” But BrainQ recently received Breakthrough Device certification, an expedited approval process that, since just the beginning of this year, also confers qualification for coverage under Medicare. This means that conceivably, BrainQ could be shipping devices very soon — though still a year or two out.

Its next step, very prudently, is a larger scale study, towards which the company intends to devote a large portion of its recent fundraise, $40M led by Hanaco Ventures, with Dexcel Pharma and Peregrine Ventures participating.”

“The reason why we raised all this money is we are on the verge of a unique study with 12 sites,” Drechsler said. While he could not yet name the hospitals or research organizations they partnered with, he said they were basically the cream of the stroke rehabilitation crop and “really we couldn’t aspire for better than getting all these top sites in the same study. There’s this excitement that maybe something new is coming — in stroke recovery there has been almost no progress in the last two or three decades, and physical therapy has been the standard for two hundred years.”

Without making any promises, he suggested that this line of inquiry could move medicine towards not just mitigating but reversing some disabilities, a feat the value of which can hardly be enumerated.

“I was looking over my pitch decks from 2016,” Drechsler mused. “Early on as a CEO, you have big dreams. We heard a lot of skepticism early on in the process, but I was proud to see that many of those dreams have materialized.”

#biotech, #brain-computer-interface, #brainq, #eeg, #fda, #funding, #fundings-exits, #medtech, #recent-funding, #science, #startups, #stroke, #strokes, #tc

MedRhythms raises $25M to get patients back in tune after a stroke

MedRhythms secured $25 million in Series B funding to advance its digital therapy platform aimed at measuring and improving someone’s ability to walk after they have experienced a neurologic injury or disease.

Morningside Ventures and Advantage Capital co-led the round, with participation from existing investor Werth Family Investment Associates, to give the Portland, Maine-based company $31 million in funding to date.

Company co-founder and CEO Brian Harris was a neurologic music fellow at Spaulding Rehabilitation Hospital in Boston, treating people with stroke and brain deficits with music. He began getting questions from patients and families on how they could access similar care outside of the hospital. Not seeing a suitable alternative, he started MedRhythms with entrepreneur Owen McCarthy in 2016.

The company’s platform uses sensors, music and software, along with an evidence-based intervention called “rhythmic auditory stimulation,” to target the neural circuitry that controls movement. The technology taps into “entrainment,” a neurologic process in which the auditory and motor systems of the brain are coupled in synchrony with an external rhythmic cue, which over time, can lead to improved walking functionalities.

“There is no other stimulus that engages the brain like music does,” Harris said. “When someone is engaging in music, it aids in neuroplasticity to create new connections and strengthen old ones. Neuroplasticity is how we can learn new things or why people with brain deficits can improve.”

MedRhythms’ product cycle. Image Credits: MedRhythms

A year ago, MedRhythms’ digital therapeutic product received Breakthrough Device designation from the U.S. Food and Drug Administration to treat chronic walking deficits resulting from a stroke. It is the first in the company’s pipeline, which is also looking at using music to treat neurological conditions like Parkinson’s, acute stroke and multiple sclerosis. To that effect, it is participating in a neuroimaging study with Massachusetts General Hospital.

Harris intends to use the proceeds from the Series B funding to get the product to market, expand the team and the treatment pipeline. The company is preparing for submission to the FDA so it can do a commercial launch of the technology and begin clinical trials.

Stephen Bruso, investment partner at Morningside, said he has known the team at MedRhythms for a year. The firm is active in the digital health space and has followed the company closely since then.

COVID served to fundamentally shift healthcare in how to deliver care. The hospital and clinic models were robust, but resistant to change until the pandemic forced care to telemedicine visits at home, he said. It also forced innovation on the industry, and at-home therapy is an area where Bruso expects to see improvement in both patient compliance and recovery, and MedRhythms is capitalizing on that trend of shifting care to the home.

What intrigued the firm for the last couple of months was the idea of affecting the brain via non-pharmaceutical needs.

“MedRhythms using musical intervention to drive changes and improvements in neurologics is compelling,” Bruso added. “Emotional memory is tied to music. Its use provides a richer experience than taking a drug, and the company exists to tap into that.”

 

#brian-harris, #funding, #health, #medrhythms, #morningside-ventures, #multiple-sclerosis, #neuroscience, #parkinsons-disease, #portland, #recent-funding, #startups, #stephen-bruso, #stroke, #tc, #telemedicine

These Sisters With Sickle Cell Had Devastating — and Preventable — Strokes

Kyra and Kami never got a simple test that could have protected them. Their story exemplifies the failure to care for people with the disease, most of whom are Black.

#black-people, #children-and-childhood, #doctors, #genetics-and-heredity, #national-institutes-of-health, #preventive-medicine, #race-and-ethnicity, #sickle-cell-anemia, #stroke, #tests-medical, #transfusions, #ultrasonic-imaging-and-sonograms

Can a Smartwatch Save Your Life?

The advent of wearable devices that monitor our heart rhythms both excites and worries doctors.

#american-heart-assn, #apple-inc, #content-type-service, #elderly, #fitbit, #heart, #mobile-applications, #pacemakers, #stroke, #tests-medical, #watches-and-clocks, #wearable-computing

Officer Attacked in Capitol Riot Died of Strokes, Medical Examiner Rules

The determination is likely to complicate efforts to prosecute anyone in the death of the officer, Brian Sicknick.

#demonstrations-protests-and-riots, #khater-julian-elie, #sicknick-brian-d-1978-2021, #storming-of-the-us-capitol-jan-2021, #stroke, #tanios-george-pierre, #united-states-capitol-police, #united-states-politics-and-government

‘We Were Flying Blind’: A Dr.’s Account of a Woman’s J.&J. Vaccine-Related Blood Clot Case

The disorder is rare, but so severe that the vaccine is on hold while experts weigh the risks and alert doctors and patients about symptoms and treatment.

#blood-clots, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #heparin-drug, #janssen-pharmaceutica, #johnsonjohnson, #stroke, #vaccination-and-immunization, #women-and-girls, #your-feed-healthcare

Suddenly the Man Couldn’t See. Was His Chest Pain Connected?

A gray cloud obscured the vision in the man’s eye. A medical student in the E.R. found the cause in an entirely different part of his body.

#eyes-and-eyesight, #heart, #medicine-and-health, #stroke, #tumors

Americans, Stop Being Ashamed of Weakness

As human beings, our vulnerability is the source of our strength.

#loneliness, #stroke, #united-states

Where Have All the Hospital Patients Gone?

Except in areas where Covid is surging, there are still no lines of patients in the hospital halls.

#anxiety-and-stress, #coronavirus-2019-ncov, #deaths-fatalities, #emergency-medical-treatment, #heart, #hospitals, #hygiene-and-cleanliness, #medicine-and-health, #stroke

How the Coronavirus Attacks the Brain

It’s not just the lungs — the pathogen may enter brain cells, causing symptoms like delirium and confusion, scientists reported.

#brain, #coronavirus-2019-ncov, #delirium, #immune-system, #muotri-alysson, #nerves-and-nervous-system, #stevens-robert, #stroke, #your-feed-science, #zika-virus

Can Covid Damage the Brain?

“I tell the same stories repeatedly; I forget words I know.”

#brain, #coronavirus-2019-ncov, #seizures-medical, #stroke

The Coronavirus Pandemic’s Needless Deaths

Seriously ill people avoided hospitals and doctors’ offices. Patients need to return. It’s safe now.

#cleveland-clinic, #coronavirus-2019-ncov, #coronavirus-reopenings, #heart, #hospitals, #mayo-clinic, #protective-clothing-and-gear, #stroke, #telemedicine

Coronavirus May Pose a New Risk to Younger Patients: Strokes

Doctors have reported a flurry of cases in Covid-19 patients — including a healthy 27-year-old emergency medical technician in Queens. After a month in the hospital, he is learning to walk again.

#blood-clots, #brain, #coronavirus-2019-ncov, #deep-vein-thrombosis, #emergency-medical-treatment, #fever, #hospitals, #lungs, #mount-sinai-medical-center, #new-england-journal-of-medicine, #new-york-city, #quarantines, #queens-nyc, #respiratory-distress-syndrome, #seizures-medical, #stroke, #therapy-and-rehabilitation, #ventilators-medical, #your-feed-science, #youth

Robotic exosuits show ‘immediate improvements’ to walking speeds of stroke survivors

A new small study out of Harvard and Boston University is targeting the use of soft robotic exosuits among stroke survivors. The aim is to demonstrate how such technologies could impact the rehabilitation of patients suffering hemiparesis, a kind of paralysis that impacts muscles and limbs on one side of the body.

The results so far seem promising. Among the six patients involved in the study, walking speed has been improved by an average of 0.14 meters a second. The patients are also able to walk 32 meters further on average during a six minute interval, with one walking more than 100 meters further.

The suit itself is small and soft, weighing around 11 pounds, including battery. Electronics aside, it’s largely fabric-based, with actuators mounted on the wearer’s hip. Those are used to assist movement in the ankles by way of attached cables. The system can be worn on either side of the body.

“The vast majority of people who have had a stroke walk slowly and cannot walk very far. Faster and farther walking after physical therapy are among the most important outcomes desired by both, patients and clinicians. If neither speed nor distance are changed by a therapy, it would be difficult to consider that therapy to be effective,” study co-author and Harvard Wyss faculty member Lou Awad says in a release.“The levels of improvement in speed and distance that we found in our exploratory study exceeded our expectations for an immediate effect without any training and highlight the promise of the exosuit technology.”

Awad says the team is “eager” to explore the results in settings outside of the lab. The team’s findings were published in IEEE Open Journal of Engineering in Medicine and Biology (OJEMB)

#boston-university, #harvard, #health, #robotics, #stroke, #wyss

Amid the Coronavirus Crisis, Heart and Stroke Patients Go Missing

Emergency physicians are seeing declines in the number of patients arriving with cardiac problems. Some say they were afraid to go to the hospital.

#austria, #coronavirus-2019-ncov, #deaths-fatalities, #emergency-medical-treatment, #fear-emotion, #heart, #hospitals, #jaipur-india, #stroke, #united-states