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Improved Assessment, Diagnosis and Management of Brain Injuries

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By David Stern

Recent events have served as sad yet significant reminders of the seriousness of head injuries or traumatic brain injuries (TBIs).

As the football season ramped up, two tragic incidents took place in October alone. Christion Abercrombie, a linebacker for Tennessee State University, was rushed to the hospital and underwent life-saving emergency brain surgery after suffering a severe head injury. In Georgia, Pike County High School linebacker Dylan Thomas also sustained a severe head injury and was rushed to the hospital for surgery, but he tragically passed away soon afterwards.

The frequency and health risks of traumatic brain injuries, which include sports-related concussions, are increasingly being discussed and studied. As indicated in Table 1, there are close to 4 million sports-related concussions each year, with an additional 50% not being reported. The risks of not properly diagnosing and treating a brain injury are severe.

A concussion temporarily disrupts mental function and if not treated, it can have debilitating long-term consequences. People with an untreated concussion may suffer from headaches and fatigue—sometimes for years. They are not as sharp as they should be mentally, and they have problems focusing.

Additionally, not promptly diagnosing a concussion and allowing an athlete to return to play even further increases their chance of harm. Right after a concussion, people are at much higher risk for further injury since they are not able to react or think quickly. Also, the brain is very sensitive after an injury. Reinjuring the brain while concussed can lead to very serious health problems—far more serious than one injury. Researchers have found that individuals who have suffered multiple concussions during their lifetime increase their chances of depression, post-traumatic stress syndrome (PTSD) and suicide by 1.5x to 3x.

Another very harmful immediate possible outcome of a head injury is a brain hemorrhage or brain bleed, which is a type of stroke. This can be a life-threatening situation. The presence of blood in the brain increases pressure on nearby brain tissue, and that reduces vital blood flow and can damage brain cells. Typically, a trip to the hospital for a CT Scan, a special X-ray test, is necessary to detect brain bleeding. Having the ability to quickly identify a brain injury and provide treatment can save lives. Yet, this can be challenging, as many tests are subjective and are generally focused on how the player feels, their ability to answer simple questions, repeat numbers and words in proper sequence and maintain balance. These types of tests cannot reliably identify brain injuries and the severity if present. Fortunately, there is a new device that is changing the way medical professionals evaluate and treat concussions. 

Electrical signals course through the brain and when someone has a brain injury these electrical signals change and are different from those that would be present in an uninjured brain.  The brain’s electrical signals can be measured and tracked by an electroencephalogram (EEG). A unique, FDA-cleared medical device named BrainScope® One uses the EEG signal to determine whether the patient likely has a brain bleed. The BrainScope One device has been thoroughly tested and has demonstrated that it can identify patients with as little as 1cc of brain blood with 99% success rate. This assessment function is referred to as a Structural Injury Classifier.

Dr. Manu Mehdiratta, a neurologist who specializes in concussion and works at the Trillium Health Centre in Mississauga, Canada explains, “The Structural Injury Classifier helps determine the need for a CT scan or advanced neuroimaging. Basically, this will tell you with a high level of certainty whether or not there is likely a  bleed in the brain, which is very useful.”

Dr. Leigh Vinocur, Emergency Room Physician, and Chief Medical Director at MedStar PromptCare Clinics says, “I was excited about BrainScope when I first learned about it because it’s 99 percent sensitive for picking up a structural injury and a bleed, even down to 1 cc of blood, which is such a small amount that sometimes doesn’t even show up on a CT scan.” 

In addition to being able to identify patients who may have a brain bleed, the BrainScope One uses the same EEG signal to determine the presence and severity of a concussion.  The device automatically and quickly compares the patient’s EEG to a large database of EEGs from healthy patients of the same age to determine their level of brain function impairment. This assessment function is appropriately named the Brain Function Index.

“Along with determining if there’s a structural injury, the BrainScope also uses EEG to determine if there is functional brain impairment,” Vinocur continues. “It uses big data from years and years of EEGs of normal brain function, so when you use it with an athlete it compares their EEG waves with those of thousands of people who never had a head injury. Then it can show you if the athlete’s Brain Function Index is lower than what it should be.”

In the words of Dr. Mehdiratta, “The Brain Function Index determines the degree of brain injury that’s occurred and guides clinical management and return to play decisions.” 

To further assess a patient’s level of brain impairment, BrainScope’s device also has two rapid neurocognitive (brain processing capability) tests. On the device, the patient takes these tests which measure  reaction time, decision making, attention span, and short-term memory, and once again their results are compared to healthy patients of the same age to assess their brain’s function.  In addition, an extensive digital library of standard concussion assessment tools is available on the device.

The BrainScope One’s ability to quickly provide this level of objective assessment in a sideline setting has quickly drawn the attention of Professional and University sports teams. For Stacey Czaplewski, MAEd, LAT, ATC, Head Athletic Trainer at Winona State University, the BrainScope One also helps athletes feel confident that they are receiving the best care possible. “We’ve been using the BrainScope for close to a year and what has been really positive about it is our student-athletes realize that it’s another layer of protection for them, and that it helps us treat their concussion and see when a referral is absolutely necessary,” she says. “When we pull it out it reassures them that we’re trying to test everything possible.”

Czaplewski also enjoys how quick and easy it is to use. “You get instantaneous feedback as soon as you download the data from the electrodes in the brainwaves, and the whole process only takes a few minutes,” she explains. “It’s also very simple to determine whether a referral is needed or not. The results are very easy to read and can help you decide what the next step should be.”

Dr. Mehdiratta shared, “For example, I recently treated a quarterback who had two concussions in a short period of time and his Brain Function Index was very low. As a result, we asked him not to play until we’re able see how he does with rehabilitation.”

Having this objective data to show athletes can be crucial to making sure they understand the significance of the injury. “It’s sometimes hard to get athletes to take their injury seriously,” says Vinocur. “They don’t want to miss out, they want to play in the big games, so they try to shake it off and minimize things. But now we have some objective data and we can show them how their Brain Function Index compares to thousands of people who have never had a concussion. It certainly makes it easier for the physician, athletic trainer, parent, and coach to get the athlete to understand it’s a significant injury and they need to rest and take time away from their sport.” 

Not only is the BrainScope One making concussion assessment easier and more objective, it is also making it more efficient. CT scans and trips to the emergency room can be costly and unnecessary, yet injured athletes often end up there anyway. That no longer has to be the case. 

“Though it doesn’t replace CT scans, I think the BrainScope is going to help reduce unnecessary CT scans,” says Mehdiratta. “In my practice, I’ve also seen that the BrainScope can reduce the cost of care and improve patient satisfaction overall.”

BrainScope One is currently FDA cleared for assessing people 18-85 years old, within three days of injury. 


Health Beat: BrainScope test for concussion

University linebacker Zane Ventimiglia suffered not one, but two concussions last season. He didn't see either hit coming, but felt them after.

"I remember being pretty off-kilter, not able to balance well," recalled Ventimiglia, 21.

Athletic director Nathan Wilder said right after injury, trainers have to rely partly on subjective tests, like how an athlete looks or says he feels.

"These kids are pretty resilient. They'll take a hit, come off and say they're OK. Then, a couple of minutes later, they're not," Wilder said.

Now, there's a new, portable device designed to give an objective assessment. The BrainScope measures brain waves.

Economic Impact on the Healthcare System using an FDA-Cleared Mild Brain Injury/Concussion Assessment Device

Read full white paper here: BrainScope One Economic Analyzer Model White Paper

Abstract

Over 30% Cost Savings to Payers and Patients Calculated from the BrainScope One Economic Analyzer Model (BEAM)

Escalating awareness of the short and long-term consequences of traumatic head injury, even when mild, has resulted in an increasing burden to the health care system to the extent of $76.5 billion annually. This white paper demonstrates potential cost reductions as high as 32.2%, shared between payers and patients when the BrainScope® One medical device is integrated into the patient care pathway.

Adoption of BrainScope One expands care access points for head injury to Urgent Care Centers (UCC) and Physician offices, more cost efficient and accessible environments. It can also improve patient triage in the Emergency Department (ED) by diverting patients from unnecessary CT scans. BrainScope One has been demonstrated to aid in more objective, accurate, rapid, and safer diagnosis of mild Traumatic Brain injury (mTBI/concussion), resulting in significant benefits across the healthcare system. This paper assesses BrainScope One’s impact on the health care system and specifically examines the potential cost savings to patients and payers using the BrainScope Economic Analyzer Model (BEAM). Utilizing realistic inputs, this model illustrates the significant opportunity for cost savings (as high as 32%) through adoption of BrainScope One.

Rockville, Maryland Urgent Care Uses Revolutionary Brain Injury Assessment Device Backed By The NFL To Reduce CT Scan Recommendations

View Original Article on Digital Journal

ROCKVILLE, MARYLAND - Identifying and detecting brain injuries early is paramount for patients as brain damage associated with concussion, stroke, tumors and other illnesses can dramatically compromise a patient's quality of life.

To effectively treat adult patients with a suspected brain injury one urgent care in Rockville, Maryland, Physicians Now, added a groundbreaking medical technology called BrainScope One to their arsenal of diagnostic tools. BrainScope One provides their providers and staff with greater assurance to objectively diagnosis the full spectrum of brain injuries, including concussions.

Medics start using scanner that could detect TBI earlier

By J.P. LAWRENCE | STARS AND STRIPES
Published: May 27, 2018
Full Source

AP LIGHTNING, Afghanistan -- Soldiers are trying out a high-tech brain scanner that tests for mild traumatic brain injuries.

The 1st Security Force Assistance Brigade is the first unit to use the smartphone-sized BrainScope device in the field.

Capt. Nicholas Koreerat, a physical therapist in the 1st SFAB, trained newly-arrived medics from the 2nd Squadron (Armored), 1st Cavalry, 4th Infantry Division on the device Saturday at Advising Post Lightning near Gardez.

Prevacus Partners with BrainScope for Upcoming Drug Study on Concussion

TALLAHASSEE, Fla., May 18, 2018 /PRNewswire/ -- Prevacus, Inc., a leading biopharmaceutical company focused on developing treatments for concussion (mild traumatic brain injury (mTBI)) and other neurological disorders today announced a partnership with BrainScope for use of their FDA-cleared BrainScope One device in Prevacus' upcoming Phase 1b clinical research study as an objective biomarker of brain function. Prevacus and BrainScope are supported in their efforts to find a solution to concussions for youth and professional athletes by 3 Super Bowl MVP quarterbacks including Brett Favre, Kurt Warner and Mark Rypien.

Potential to Reduce Emergency Department Referrals From Urgent Care Centers By Up To 75% for Mildly Presenting Head Injured Patients

Read full white paper here: BrainScope One Urgent Care ED Diversion White Paper – May 2018

Abstract
The standard of care today for assessment of traumatic brain injury (TBI) in the Emergency Department (ED) remains the head CT scan, despite the fact that 91% of those scanned are reported to be negative for structural brain injury. Since approximately 95% of head injured patients present as mild, there are a very large number of unnecessary CT scans performed for the mTBI/concussion population. Urgent Care Centers (UCC) have the potential to significantly impact on initial triage and assessment of mild head injured patients, yet today standard clinical assessment capabilities in UCC result in a large percentage of such patients being referred to the ED for CT imaging, most often found to be negative. The ability to objectively assess these patients at the UCC could greatly improve evaluation and care of the mTBI/concussion population. BrainScope One is a novel handheld, rapid, easy to use, FDA cleared medical device to aid in the objective assessment of full spectrum of brain injury, including the likelihood of a structural brain injury visible on CT, with high accuracy shown in a prospective independent FDA validation trial. This White Paper evaluates the reduction of unnecessary UCC referrals to the ED for CTs when BrainScope One was integrated into the clinical decision pathway, based on 196 patients whose data was entered data into the BrainScope One Registry by 12 UCC. Significant reductions in ED referrals were realized (as high as 75%) when BrainScope One was used to aid in referral decisions across a wide range (100% to 50%) of prior clinical practice referral rates, supporting the potential to significantly impact on ED diversion and reduction of unnecessary CT scans in the mild brain injury population, benefiting the patient and reducing costs to the healthcare system.

Potential Significant Reduction in Unnecessary CT Scans in Emergency Departments Using an FDA Cleared Medical Device for Brain Injury Assessment

Read full white paper here: Washington University Emergency Department White Paper

Abstract:
Despite the fact that most CT scans performed on head injured patients are negative, CT remains the “gold standard” for evaluation of head injury in the Emergency Department.  This study investigates the utility of the BrainScope One EEG based classification algorithm to aid in the reduction of unnecessary CT scans in the mild head injured population.  Evaluations were performed on 64 patients (mean age 43.5, 58% male, 98% GCS=15), enrolled in the BrainScope One Registry, who sustained closed head injury and were evaluated in the ED at Washington University (mean time since injury 10.1 hours) and were referred for CT scans by standard clinical site practice pathway. Results were compared with those from BrainScope One evaluation. In this population of ED patients, the BrainScope One decision pathway would have resulted in a 32.8% reduction in the overall number of CT scans referrals compared to the clinical site practice decision pathway.  Importantly, this reduction in CTs was achieved without incurring any false negative cases (100% sensitivity). 

 

New Tool Takes On Early Detection Of Brain Injuries

Source: http://baltimore.cbslocal.com/2017/09/12/brainscope-brain-injury-tool/

By Alex DeMetrick

BALTIMORE (WJZ) — When it comes to looking for the first signs of concussion or other brain injuries, a new tool is available from a Maryland company — and it’s being backed by the NFL and the Department of Defense.

The device, called BrainScope, comes in two parts. It includes a disposable electrode headset, and a military-grade smartphone with specialized software.

The tool is designed to give an objective appraisal of possible brain injury as early as possible after an accident:

“So much of brain injury assessment is subjective, and so what we are adding is objectivity. You’re literally reading the brain electoral activity of the patient,” says Michael Singer, CEO of BrainScope.

“Close your eyes, relax and keep your feet flat on the floor.”

The software compares activities of an uninjured brain, like relaxing, with the readings of someone who suffered a concussion.

It also compares cognitive functions with tests taken by the patient, which could lead to a CT scan.

“We run multiple tests and that aggregation is what is then used by the clinicians for them to make a diagnosis,” says Singer.

Supporters of Bethesda-based BrainScope include the military, with the defense department providing funding, as well as the NFL, where brain injuries to players have gone from locker room secret to full-blown headlines:

“There’s just no denying a lot of guys out there like me dealing with the stage of brain injury,” says former NFL player Mitch White.

The portability of BrainScope means versatility with FDA approval.

“It’s meant to be anywhere a head injury might occur, so our markets are places like urgent care centers, emergency room departments in hospitals, the military, universities,” says Singer.

 

Capital Flows to Money-Making Brain Companies

Startups attract funding to expand sales of tests, tools to detect and
manage brain injuries and illnesses

By Brian Gormley

Sept. 11, 2017 7:30 a.m. ET

Original Article: https://www.wsj.com/articles/capital-flows-to-money-making-brain-companies-1505129401?tpl=venturecapital

Venture capitalists have money in the brain.

After years of research and development, many startups have introduced money-making products or services aimed at conditions of the brain, attracting more capital.

Brain startups with revenue closed 26 venture financing rounds in the first half of the year, on pace to pass the high reached in 2015 of 44 financing rounds for revenue-generating brain companies, according to Dow Jones VentureSource,

These private companies are gaining traction serving a range of conditions such as depression, anxiety and concussions.

The percentage of investments in those ringing up sales is rising. In 2008 the portion of brain investments in startups that were generating revenue was 13%. By 2012 that figure had risen to 40%. Last year, there were 38 financings in revenue-making startups in the brain category, or 42% of the total. In the first half it reached 50%.

BrainScope Nominated for the 2017 11th Annual Prix Galien USA Award for Best Medical Technology Product

NEW YORK, July 26, 2017 /PRNewswire/ -- The Galien Foundation announced today the 2017 11th Annual Prix Galien USAAward Nominees. Counted among the global health innovation industry's most prized honors, the Prix Galien Award recognizes outstanding biomedical and technology product achievement that improves the human condition.

To qualify, each candidate must be U.S. Food and Drug Administration (FDA) approved for market within the last five years and demonstrate tremendous potential to impact human health. Sales data are not considered by the nominating committee in their award nominee selection; only science and health impact.

Source

NFL: Advancing Concussion Diagnosis

In 2013, GE and the NFL teamed up to launch the GE-NFL Head Health Initiative, a four-year, $60 million collaboration to accelerate diagnosis and improve treatment for traumatic brain injury.

The initiative’s three-part Head Health Challenge open innovation program allocated $20 million for awarding grants to scientists, academics, entrepreneurs and other experts with leading ideas.

BrainScope used support from the Head Health Challenge to develop a new hand-held device that also has the potential to transform front-line care of head injuries.

BrainScope’s Ahead 300 headset and smartphone uses “sophisticated algorithms” to analyze patients with head injuries. It’s a quick test that is intended to provide “a rapid, objective assessment of the likelihood of the presence of traumatic brain injury (TBI) in patients who present with mild symptoms at the point of care.”

It was built in part through grant support from the GE-NFL Head Health Challenge. The U.S. Department of Defense also collaborated on the project.

In September 2016, the U.S. Food and Drug Administration gave the green light to BrainScope to begin marketing the Ahead 300.

 

Source: NFL Play Smart Play Safe (Click here to see NFL video with BrainScope)

NFL: New Handheld Device To Transform Front Line Care of Head Injuries

DISCLAIMER: The Ahead 300 is intended to be used in Emergency Departments, Urgent Care Centers, Clinics and other environments where trained medical professionals and practitioners practice medicine under the direction of a physician.

Is This the Diagnostic Tool We’ve Been Waiting for in Concussion Testing?

A startup says its technology can serve as an objective concussion test. The challenge is convincing people it works.

By Mike Orcutt  MIT Technology Review - Biomedical

Concussion diagnosis is a notoriously tricky science.

Even if an assessment test on the sideline of a football or soccer field deems you to be concussion-free after a blow to the head, that doesn’t necessarily mean you didn’t suffer one, says Michael Singer, CEO of BrainScope, a Bethesda, Maryland-based company that has developed a new technology for detecting signs of a concussion in a person’s brain waves and has raised approximately

This brain-scanning headset knows when you have a concussion

Chris Weller

Super Bowl 50 is here, which means athletes will be trying harder than ever to deliver big hits.

A new medical device designed to identify traumatic brain injury (TBI) might not be far behind.

BrainScope is a one-two punch headset and mobile app that quickly and easily allows clinicians to determine whether patients have sustained a TBI.

It follows a growing body of research that tries to understand what head injuries look like and, more importantly, what clinicians can do about them so people stay safe.

Michael Singer, BrainScope's CEO, says many of the current techniques for evaluating someone's level of injury are flawed because they rely solely on symptoms.

If someone sustains a nasty hit, for example, they may complain about head pain — or they might not.

In the NFL, athletes are only required to take a baseline exam at the beginning of the season, called the ImPACT test. If they suffer a head injury, they take the test again to check for any fall off in their score. But even this standardized test has been found to yield false positives.

BrainScope cuts through that unreliable self-reported data to ...


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Super Bowl 50: amid NFL's golden era, hints of a sweeping change

SHIFTS IN THOUGHT 

The Super Bowl shows the NFL is more popular than ever, but the game could change in fundamental ways because of mounting public concerns over head injuries. 

By Gloria Goodale, Staff writer FEBRUARY 6, 2016

  David J. Phillip/AP

David J. Phillip/AP

A BrainScope device is displayed before an NFL health and safety news conference Thursday in San Francisco. The device can be used to help diagnose traumatic brain injuries. (AP Photo/ DAVID J. PHILLIP/AP

LOS ANGELES — National Football League news this week told two dramatically different stories.

On one hand, there was the run-up to the Super Bowl, with all the anticipation and intrigue around whether the Denver Broncos can stop the juggernaut that is Cam Newton and the Carolina Panthers.

Last year’s ratings for the game – a record 114.4 million viewers – suggest the NFL has never been more popular.

Yet there was also the story of Kenny Stabler, the late Oakland Raiders quarterback who was revealed to have been diagnosed with CTE, the degenerative brain condition linked to many former professional football players.

The contrast was both poignant and apt, many say.

At a time when the NFL is the unrivaled king of American professional sports, concerns about ...

 

Keep reading in The Christian Science Monitor »

 

NFL Shows off Technologies to prevent concussions at Moscone Center

As part of the lead up to Super Bowl 50 the National Football League is showing off technologies it is funding to help prevent concussions among players.

By Eric Thomas

Thursday, February 04, 2016 11:47PM

SAN FRANCISCO (KGO) --

As part of the lead up to Super Bowl 50 the National Football League is showing off technologies it is funding to help prevent concussions among players.

The show was timely. A week after the NFL released numbers showing an almost 60 percent increase in reported concussions last season, they brought in medical experts to talk about it

"I believe very strongly that the NFL has an unmatched opportunity and platform to affect change when it comes to player health," said Betsy Nabel, the NFL's chief medical advisor.

The league showed off companies funded by something called the Head Health Initiative. These firms have used grants to come up with projects to try and protect players from head injury, like a helmet that uses special shock absorbing structure to reduce brain-rattling force.

"When you hit it gives a little bit, like a car bumper and redistributes the force," said Samuel Brown, a neurologist.

One strange looking invention tries to diagnose concussions by examining brain waves.

"We look at particular patterns within the brain and then use a sophisticated algorithm to decipher those patterns," said Michael Singer, the CEO of Brainscope.

The NFL has fought a public relations battle, with players filing suit saying they weren't told about the dangers. And even a big screen movie, "Concussion," about the doctor who first recognized concussions could lead to a deadly condition called CTE.

Retired players worry about what will happen to them.

"As a linebacker if you don't know that you're hitting people with your head and there could be a problem, I mean you're kind of crazy if you don't realize that," said Chris Draft, former NFL linebacker.

Even if these products prove effective there's still one thing scientists will have to deal with, the fact that players get bigger and stronger every year.