A New Understanding: Concussion Definition, Diagnosis and Management
Scott Anderson is a recognized concussion expert having spent 4 years at St. Mary’s University and 10 years at Stanford as the Director of Athletic Training. He is currently Chief Clinical Officer at SyncThink and is also a Medical Observer for the NFL. In this episode Scott describes what a concussion is, the symptoms, who should diagnose and treat the injury, medical devices used for concussion monitoring, why objective test data is vital, how the SyncThink technology is contributing to concussion management, and the future of eye tracking technology.
Links from this episode:
Mastering Medical Device:
Episode Transcript
This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Patrick Kothe 00:32
Welcome. When I was 15 years old, I was a running back at McKinley junior high school. And I went through the line on a 42 trap one one game, and was actually lit up by the linebacker. And what I remember is I remember waking up on the field, and trying to get back up and just fallen right over. And I can still feel that today. Well, I didn't go into the doctor, my dad called the doctor, and the doctor told my dad, take me home, wake me up in the middle of night. If my pupils were fixed and dilated, I should head to the ER, Doctor told them, Hey, I'd probably have a headache, which I did. And when it went, when it went away, I was good to go back and play. That was kind of the state of the art in concussion management. Back in the day, the attitude of the coaches and the players at the time was, you know, really be a man, rub some dirt on it and get back back out there. I remember having a few more concussions because I played linebacker in high school in college. But back then again, it was not that big of a deal. However, I'll tell you that my interest continued over the years. And I actually founded a company in 2012, called NeuroChaos Solutions that was focused on identifying and monitoring concussion. And I'm gonna talk a little bit more about this in an upcoming episode. But concussion is such a common injury. And I'm sure most of you have your own stories about your own concussion or one of your kids or several of your kids concussions. But our understanding of the injury really has evolved. And not only the injury, but how it's treated. It's really drastically changed, especially in the last five, six years or so. So, today's episode, I'm really happy to explore this further. I'm happy to have Scott Anderson join us and Scott's going to explain the current state of concussion. And not only understanding what a concussion is, but what management looks like. Scott's an expert in the field clinically, as well as a medical device professional. Scott spent four years at St. Mary's University, and 10 years at Stanford, as a Director of Athletic Training. The joined SyncThink, where he's Chief Clinical Officer and SyncThink what they're doing is they're developing technology that provides objective measurements to common neurological impairments and can get in conditions like concussion. In addition, Scott works for the NFL, and he's been doing that for over 10 years. And what he's doing is he's a medical observer, or what's referred to as an eye in the sky at NFL games. In our conversations, Scott describes what a concussion is, what the symptoms are, who should diagnose and treat the injury. Different medical devices used for concussion monitoring, why objective test data is vital. How the sink think technology is contributing to concussion management, and the future of eye tracking technology. Here's our conversation. Scott, the timing of your career has really overlapped. The drastic change in the profile of concussions and concussions are pretty common injury, Injury, but they've been misunderstood and, and mismanaged and misdiagnosed for a lot of years. So what what really helped to turn the tide and how we think about this, this injury and how serious it really is.
Scott Anderson 04:31
Sure, well, I think it was a couple of things. One is, I think from a public perspective, certainly there was a lot of I think increased awareness around concussions, thanks in large part to to professional football in the United States. I think that helped, you know, a lot and, you know, books being written investigational journalism pieces being written about, you know, the crisis of concussion and how they're being managed in professional sports in particular emphasis on you know, the question quote unquote, dangers of playing contact and collision sports and the rise of chronic traumatic encephalopathy. You know, the public had never really heard about CTE until a couple of books were written about them. And and some foundational studies were published about it. And although this is something that ultimately hadn't been discovered or identified previously, it just didn't have the the, you know, the recognition in the public's awareness that this is something that can happen to people who, who bang their heads together. And so I think that was one thing that was happening. And I think, simultaneous to that the scientific community realized that we're really not doing a very good job of helping patients recover from this condition. And part of it is because we lack a lot of evidence around how to manage the condition properly. And I think, in 2014, and 2015, you saw some of the first kind of consensus meetings get together and recognize that this condition really warrants stratification, or, you know, phenotyping, as it were, many other neurological conditions, like headache, for example, are classified into different segments, sub segments, that can be the basis for improved diagnostic capabilities, but also better treatment outcomes for patients. And I think the scientific community kind of took a step back and said, We've got to pump the brakes and all the hysteria, we still have a raging kind of epidemic in this country around the problem. But really, we're not equipped with the things that we need to properly address the problem. So we need to start looking at the evidence and start looking at what we can do from, you know, a research standpoint to further our understanding of the natural history of head injury and to position ourselves to devise better approaches so that patients can ultimately have better outcomes. It's interesting,
Patrick Kothe 06:53
you're using the word condition, and and not the word injury. Why are you using the using that that term?
Scott Anderson 07:04
Well, because I think, you know, if you've looked at the approach to concussion management and scientific community for the last five to six years, we recognize that it is a treatable condition, it is heterogeneous in nature, which means that no two concussions are the same. But there are also things that can be done so that people can recover from them. And that's what's been missing for such a long period of time is that people really, the public hasn't realized it, and many people who are treating concussion hadn't realized that this is a condition that can be properly resolved with the right diagnostic interventions and therapeutic approaches. And, you know, that's what I was referencing earlier. With respect to, you know, what changed about concussion is, you know, this, this understanding that we needed to do better. And ultimately, I think, over the last five years, many clinicians like myself have recognized that, you know, this is treatable, and that we can ultimately disarm some of the some of the concern that many patients and particularly parents of young people have, by telling them look, this is something that can be addressed, and to give them optimism and hope about the condition of the patient and the ultimately, the prognosis.
Patrick Kothe 08:11
I think you're you're absolutely right. I mean, there was concussion hysteria for a few years there, and it seems to have calmed down. And, and the evidence based approach is really the only correct approach to do this. I mean, the history is gonna run, run its course. And then you really have to have the evidence that comes out to say, this is exactly what we're dealing with. This is how we're going to treat it.
Scott Anderson 08:34
Yeah. And, you know, one of my colleagues during my time at Stanford, you know, he was part of a large group that put together some studies that looked at the evidence base behind concussions, and they examined every single publication on concussion, and they looked for evidence base, evidence based indicators of the condition. And after reviewing over 5900 publications, they found eight that had objective clinical evidence to support what the diagnosis actually should be, what the criteria should be for making the diagnosis. And so really, what it comes down to is there's just a stunning lack of a clear evidence that allows clinicians to in a unified way to diagnose the condition the same way every time, and what what has ultimately happened and how we failed the public, as providers is that we have not had that. And as a result, it's allowed every clinician to come up with their own way of diagnosing the condition. And so that means, you know, listening to the patient's symptoms and making a diagnosis based on their symptoms, or just because I've, you know, seen a million of these before, I know this is concussion, I'm not going to go any further into examining you. I'm not going to even perform a neurologic exam, because why would I do that? I've seen this a million times you have a headache, so you must have a brain injury. And, you know, I think we've done a disservice to a lot of people as a result of that way of thinking and you know, it was right for For, for disruption, as I like to say, you know, it's a long time coming.
Patrick Kothe 10:05
And you know, the the term that I've often heard is, you know, when you've seen one concussion, you've seen one concussion, it they're all unique. Every person is going to react a little bit different, every every concussion is going to be a little bit a little bit different. So let's get into what exactly we're talking about. So concussion is mild traumatic brain injury, or mTBI. What is what is going on what causes a concussion?
Scott Anderson 10:32
Yeah, so I'm happy to take the time to dispel some of the myths around this because this is part of what has largely been driving the misperception or even the lack of knowledge the public has had about this condition. Concussion is an umbrella term underneath another umbrella, you know, we think of traumatic brain injury as the larger umbrella that concussions sits underneath. There are two different types of traumatic brain injury, you can have a severe traumatic brain injury, which is more of an anatomical disruption. So you're this is what we're experiencing when people have subdural hematomas, or bleeding in the brain, and changes to the structure of the actual anatomical features that make up the brain. These are severe injuries that are often occurring in motor vehicle accidents. We see this happen with our military quite often they have severe traumatic brain injuries, and this is a lifelong condition that leads to various types of lingering deficits that last a lifetime.
Patrick Kothe 11:34
And and often this is still a closed head injury.
Scott Anderson 11:38
Exactly, exactly. Yes. So you know, there's there's swelling, there's bleeding inside the brain. And these patients are often associated with coma, or other types of, you know, severe conditions. Whereas concussion is a subset of traumatic brain injury that we refer to as mild traumatic brain injury, which is the actual function of the brain. It's the wiring of the neural networks between different aspects of the brain that gets disrupted. If you think of, we used the analogy all the time, like a freeway system that's passing between two cities, it's not the cities that are being disrupted. It's the messaging that's happening on the freeways between those two systems that ultimately lead to temporary impairments that can be resolved with appropriate intervention. And so I always try to tell people, I think, the public has always had this perception that your brain was on fire, and you're, you know, the fire need to be put out. And we perpetuated that belief by telling people to go sit in a dark room and to do nothing, until the flames went out, and the smoke went out of your ears, and you felt great. And that would be the indication that everything's healed, and you go back to your life. But I always challenge patients to think of anything other providers to think of another condition that we do that for, right. Like, if you sprained your ankle, we don't tell you to go sit in a dark room and lay down until your ankle feels better. And then you get up and walk around, right, there's some things you have to do to get back to the things that you were doing before. And ultimately, what we've learned is that those are the that's the case, you know, is that this ultimately is a functional disruption, that can be actively rehabilitated, just in the same way that we rehabilitate parts of our body that we can actually see. And there's a lot of mystery associated with the brain because we can't see it. And so we don't know what's going on, really, because I can't really feel it, I can't touch it. And I can't look in the mirror and see it and see how it's doing compared to, you know, my other limb or something like that, that I can say, Oh, this is feeling better, this is doing better today. I have a certain way that I feel, but I have a hard time being able to correlate how I feel and all the things that are happening to me and associate that with what's happening to my brain and what part of my brain that is and what I need to do to fix it. Right. And so there's, I think, a lot that we still don't know about this condition, and that the public doesn't know and that we have to as providers, it's incumbent upon us to do a better job of educating them and to getting them to understand the differences between concussion and other brain related conditions.
Patrick Kothe 14:09
Scott, could you explain a little bit about how the brain is sitting inside the skull and how it's kind of as floating in there and except what acceleration and deceleration rapid acceleration deceleration is actually doing with the brain?
Scott Anderson 14:23
Sure. So this is another point that I want to try to dispel. Because, you know, over the last 10 years, we have other research that has dispelled this idea of what people are referring to as coup and contrecoup injuries, which means that your head is sitting inside of a sack of fluid, and when you hit your head against something, your brain bounces on the inside of your skull, that's actually not what's happening with a concussion. And I think a lot of people still to this day, and I believe that's the the mechanism of the injury and how this occurs. And I think while the brain is suspended in cerebral spinal fluid, and sitting inside a egg like structure or you know Almost like a jello like appearance that when it moves, it wiggles, it doesn't generate enough force to where it's banging on the inside of your skull or create that much movement. I don't think that ever, from an evolutionary perspective, we would last very long, but that actually was happening. But ultimately, what it comes down to, it's all about shearing. And it's about shearing of the brain, from the inside out. And if you look at our, the way that we're built, the majority of our head sits in front of our spine. So I always use this kind of visual where, you know, this is my spinal cord, and my head is sitting in front of my spine. And so there's a, there's a propensity, a flaw in our design to the point where our head can be whipped back and forth, or up and down, because we don't have the the weight of gravity to absorb it through the rest of our body, because we're in front of our, our spine. So that's one key aspect of understanding the risk of concussions that we face from an anatomical structure. The other part is that because of this whipping, the brain actually doesn't bounce against something, it actually pulls apart. And so you get shearing mechanisms that occur in the white matter, particularly in the central midbrain and the brainstem, that is a result of the forces pulling the brain apart are are pulling the brain in different directions at the same time, and these accelerations of our head, so two heads colliding or not me being hit in the chest and my head snaps back that causes the acceleration of my head and causes the shearing mechanism of the tissue within my brain, deep within my brain.
Patrick Kothe 16:34
And also, from a soldiers perspective, when you've got a got a bomb or some type of explosion, that's gonna cause it to
Scott Anderson 16:42
Yes, exactly. And we see in military mechanism of injury with traumatic brain injury we often see almost like a overwhelming wave. And so there's a wave of occurrence that comes that overwhelms the actual position of the soldier and causes the acceleration of the head as a result of that wave like thing versus a direct contact. And so you can have the same type of injury, mild traumatic brain injury or concussion, as a result of the shearing mechanism. That happens, even when you're not, you know, hitting your head against another player's head or having some type of contact, it's gonna happen just as a result of this wave of force that comes that accelerates your head as a result of that. And ultimately, what I was referencing earlier about the freeways being pulled apart, that's exactly what's happening, those freeways are being destructed, are being pulled apart from those other areas of the networks in the brain that are, you know, connected and sending messages to each other about how to coordinate sensory motor control. A lot of that is disrupted as a result of that. So you have potholes or cracks or disruptions in those signals and in those freeways that are carrying messages to different aspects of the brain. And ultimately, those are what need to be rehabilitated.
Patrick Kothe 17:58
So people hear concussion a lot of times they think it's a football injury. And it's it's motor vehicle accidents. It's people in military, it's it's workforce things, it's young children who have large heads, and they fall, it's older people who, who fall as well, as well as the sports related injuries. Football is a bad actor for concussions. But there are also a lot of other sports who have significant amount of concussions as well can outline a few of those.
Scott Anderson 18:27
Sure, yeah. First, I'll say that, you know, the number one culprit of a head injury in the public is a bike accident. I think there's a misnomer within the public to as well about the utility of helmets. Helmets are designed to prevent skull fractures. They're not necessarily designed to prevent a concussion. So you can wear a bike helmet, which is going to protect your head, but it's not going to protect your brain. So much. So when we're talking about sports, non recreational activities, any sports that require contact, so, obviously, you know, sports, like soccer, are tremendous, you know, incidents of concussion with those sports, you know, anything like that, like ice hockey, or rugby, where there's collisions happening or accelerations happening where, you know, there's some potential for contact and the the head position to change over the course of time, whether that's, you know, through direct contact or through some other type of acceleration. Those are the primary sports. You see it less often in sports where there's not as much contact they still does, it still does happen, you know, baseball players getting you're running into the outfield wall or being hit with a pitch those types of things a catcher, getting a pitch off the face. You know, those those are also ways that concussion mechanisms can occur in sport. Cheer happens in chair. Yeah, yeah, people are getting dropped in cheer and you see it in wrestling. People don't realize wrestling too as well. You know, it's a heavy, heavily played high school and collegiate sport. And those athletes are constantly being picked up or you know, rotated in different positions and are landing and having their head accelerated upon landing and hitting the mat. And so, you know, it's pretty much pervasive in any sport, it's just, you know, the differences between them are dependent on the types of impacts that are occurring as a result of the sport.
Patrick Kothe 20:12
So let's talk about the prevalence of concussion. Because there's numbers, there are numbers that are out there about number of concussions that occur annually. But there's also a lot about non reported concussions. So can you enlighten us a little bit about reported and what's estimated to be non reporting, you
Scott Anderson 20:32
know, what the literature tells us? You know, this is probably NIH data, and other data from, you know, other sources that are stating that the average concussion reporting in the United States at least is around 3.2 to 3.6 million concussions a year. And that's largely based on emergency room visits. And I have some thoughts about the emergency room, which I'll share later. But what I will say is that not everybody's going to the emergency room, because not everybody knows that they've what a concussion is or what it feels like or that they haven't experienced one. And so we think that there's a tremendous amount of underreporting, potentially 50% of concussions are probably being underreported in the US. So I think that number is somewhere around seven and a half million a year, because people aren't showing up to the emergency room, or they're being cared for at other locations. You know, they see their primary care doctor, or they're part of a sports team that has an integrated health care system that's managing their concussion, too, as well. None of that data is related on related to, you know, collegiate and professional sports incidences where this is largely happening as well. So I think, you know, with respect to concussion, there's quite a bit more happening than we realize. And I think part of that also is that we are probably not necessarily diagnosing it the right way, because we lacked diagnostic criteria, you know, and like I said, earlier, doctors are doing whatever they want. And everyone's everyone's has a different way of diagnosing the condition. So it's very difficult for us to know for certain that somebody has a actual change in their brain function, because we don't have any current way to measure that. And if you go to the emergency room, you're going to get a very expensive CT scan, that's not going to tell you that you have a concussion, it's going to tell you whether or not you have a brain bleed, and that you have a severe traumatic brain injury, not a functional injury to your brain. And so you know, it, you're left with diagnosis by exclusion, which is, Oh, you don't have this severe form of brain damage. So it must be something else it's going to, it's probably a concussion, so you have a concussion. And that's how it's being diagnosed today.
Patrick Kothe 22:47
And the other thing is, sometimes the concussion is immediate, the constellation of symptoms, or the reaction of the body, if you can see immediately, and sometimes it may take a little bit for to manifest. So you don't you don't have that immediate injury. It's not like you know, you broke broke a leg, you can see that immediately, that concussion may not manifest for a little bit of time as well.
Scott Anderson 23:15
That's correct. And I think there's a couple things happening is that you can have symptoms that manifest and change over time, that could manifest immediately and change over time. Because your unique composition dictates how that progresses. If you've had a prior history of another condition, it puts you at risk for having other types of symptoms, as a result of that, that will manifest over the time that the brain is injured, or the you know, the functional impairment has occurred. And conversely, you may not have noticed any type of change that's related to cognitive function that may in in fact, change over time, or manifest later, when your endorphins come down, or when you're done, you know, your heart rates not beating as much or you're not, you know, riding the, you know, the wave of the, the activity that you're participating in, where you're concentrating on something else. As soon as you come down from that you're like, Oh, now I feel really dizzy, or now I've got this raging headache. So yeah, they, again, that's why we say it's a heterogeneous injury. And everybody has a different experience with it. And it's largely due to who we are, what we've, what our previous history is about, and other things like family history contribute to that and our environment contributes to that as well.
Patrick Kothe 24:28
So Scott, you mentioned occasionally we do have instances where there is a bleed going on and becomes a life life threatening thing. There's a both closed closed head injury so if somebody is on their bike, they fall down and something happens and they know that there's an injury there. When do they go to the ER and when do they manage it as more like a concussion we went when when do you have that concern that I need to get to the ER because I suspect or maybe something more severe going on?
Scott Anderson 25:02
Well, I think a couple things. One is, obviously, the severe traumatic brain injury is a medical emergency and you want someone to go to the emergency room as quick as possible. Often what we see is that deterioration of cognition and also an alteration of their status. And so what I mean by that is that they could start to lose consciousness or fade in and out of consciousness. And that's ultimately a red flag, immediate referral to the emergency room, we've got to get them seen immediately. And you know, that, that if someone has even just a small bleed in their brain that can be readily apparent in just a matter of a few minutes. Whereas we, we can also see patients who have, you know, maybe less severe, but still a severe traumatic brain injury that's leading to a bleed, and this can manifest itself over, you know, a number of hours. And so the key is to monitor the patient and to make sure that their symptoms are actually monitored, but, but I think, from my perspective, that anybody that's educated around the topic and knows what to look for, whether they've been advised by a healthcare provider or not, can can ultimately, you know, know, when someone's, you know, fading out of consciousness and not paying attention, or, or you know, is not acting like themselves.
Patrick Kothe 26:16
I read your, for this, your risk for this is really kind of in that within the 1012 hour period of time.
Scott Anderson 26:23
Oh, yeah, absolutely. Yeah, yeah, even less so. And I think, I think if you can, I think we've had previous recommended recommendations that have been out there where people have been told, wake somebody up every hour, and don't let them fall asleep at night. That's what you're trying to do, trying to monitor them to see if they actually do develop a bleed, and they become subconscious, and you can't wake them up. And so waking them up every hours, make sure that they're they're not like that, you know, what we found a concussion, which is much more likely to occur or has, you know, I would say more prevalence and the severe injuries is that that's contributing to the exacerbation of their symptoms by waking them up and telling them they can't go to sleep, because sleep dysfunction is and disordered sleeping is a telltale sign of concussion, and one of the key indicators of the problem and so by not letting them get to sleep, you're exacerbating the problem. So, you know, a lot of these things, we learned the hard way, unfortunately. And, you know, this is something that, you know, it's a, it's a, it's important for the public to understand and important for providers to provide the right guidance for.
Patrick Kothe 27:30
So what are these indicators of the condition? What are the symptoms that people see?
Scott Anderson 27:36
Yeah, so it's ultimately a change in cognitive function. That's what we want to look for. It's the way that people think it's the way that they act, it's the way that they interact. Ultimately, what people are going to probably know most, I would say most recognize about people that they are most frequently interacting with someone who has a concussion, that's a family member, who you interact with every single day is there's going to be a change in their effect, right, the first thing you're going to notice about them is that they're acting differently. And you're going to be wondering why it can potentially be that they have to become more agitated or become more emotionally labile, their personality can flip, they may also have problems with concentration, or being able to pay attention for long periods of time. Or they may have problems not being able to remember what they just said, you know, temporarily, they may forget who they're talking to, or, you know, in the middle of their sentence may just like all of a sudden forget what they're about to say, and just stop talking in the middle of their sentence. So there's all these little things that occurred that, you know, present differently in every single person because of who they are. And, you know, it's important for people, I think, to realize that these are all things that can be considered as part of, you know, the injury. when it occurs, I think the number one sign that we look for, which is very non clinical, and very difficult to diagnose people off of based on a concussion of headache, headache is the most prevalent type of, you know, indicator of a potential head injury. But it's also an indicator of 36 other types of medical conditions. And so you cannot use headache alone to diagnose concussion. What I will tell you is that, with the newest approach based on the newest literature over the last five to seven years, we're using these clinical phenotypes and subtypes to identify not just what the symptoms actually are, but what are the dysfunctions that are causing the symptoms. And that's ultimately what people in the concussion care community are after right now, which is it's not good enough to just understand what the patient's symptoms are. It's what is the what is the reason why those symptoms are manifesting. And so besides headache, the most commonly identified phenotypes of concussion are vision problems. So having an ocular motor or a visual problem, so seeing double, having trouble tracking a moving object, having the ability to be able to fixate on still object while you're moving those frames produce all of your symptoms, those are things that are highly highly, highly common in people with concussion, vestibular problems, so having balance or postural difficulties, having inner ear difficulties to where you feel dizzy as a result of even just turning your head to one direction, or having to move abruptly, based on a changing landscape, those can elicit symptoms as well as feeling unsteady or feeling like you're you're gonna tip over. The other ones are fatigue, like significant cognitive fatigue, like you have a battery issue and your the way that you operate during the day, and at two o'clock you're out of gas and you want to go to sleep, you know, that's a big one that can bring on a manifestation of a whole host of different types of symptoms. And then the others are mood disorders. So, you know, many patients suffer with depression, anxiety as a result of concussion and can feel this is part of the effect change that I referenced earlier. You know, and those can, those can be highly prevalent, particularly in young people as well as feeling more depressed or anxious, particularly if they are isolated from their social environment, because their life is, you know, basically being taken away from them, and they can't do their sport, they can't interact with their friends, they can't go to school, this is likely to drive the depression and anxiety. And then, you know, there are other things like, you know, cervical, cervical injuries, sleep issues, those are all parts of, you know, how we tried to identify measurable impairments from concussion that lead to symptoms that we can treat.
Patrick Kothe 31:32
Scott, let's talk a little bit about the, the people who treat concussions, because depending on where you are, you may have access to different things. If you're, if you're at Stanford, you've got, you know, excellent athletic trainers, and you've got people who are trained to deal with these issues, and you have physicians that are that are trained to do it. If you're in a high school or, or a middle school level, it's going to feel blessed if you're in a large city, small city. What what happens? I mean, because it's managed by athletic trainers, pediatricians, Family Medicine, physicians, sometimes people will take their kids to neurologists, sometimes there there are concussion specialists, you know, quote, unquote, with within your city as well. Where should people go?
Scott Anderson 32:21
Yeah, that's a great question. Well, I'll first start by telling people where not to go. And that's the emergency room. The emergency room is not equipped to tell you whether or not you have a concussion, they can tell you that you may not have one may not have a brain injury, because they'll Dell send you a $9,000 bill for a CT scan, and tell you that, look. There's no bleeding in your brain. So it must be a concussion. Because, you know, we've been able to tell you, you don't have a severe brain injury. But they have no other way of being able to utilize technology to diagnose concussions, and they don't really, it's not the place for them. So they're not really trained in how to do that. If your life is in danger, it's a great place to go. But if you've got a head injury, I always tell people that you should find a neurological specialist, a neuro specialist, someone who specializes in treating concussion and making the diagnosis of concussion. Specifically, I also tell people that it's a it should be a red flag to you if only one provider is the person that's caring for you. So if you're only going and seeing a physician and you see the physician three weeks later, and you see the physician three weeks after that something's off. This is a condition that requires a multidisciplinary approach. And so you have to have multiple people that you interact with to help you recover from the condition and it's not just the physician, whether whatever type of neuro specialist they are, it can be a neurologist, it can be a primary care, sports medicine physician, it can be a a emergency physician who's trained in sports medicine. It can be a neuropsychologist, it can be a neuro psychiatrist. It can be a neurosurgeon, all of those people. There are there are 1000s of those types of professionals who specialize in concussion diagnosis. There are other types of clinicians like physical therapists, athletic trainers, neuro optometrists, chiropractors, neuro chiropractors, in fact, that are all seeing patients after the diagnosis has been made in order to remedy deficits that had been identified during the diagnostic workup. And so, the key and the I would say the new approach to managing concussion is to make a diagnosis based on an identifiable and measurable deficit that can be corrected by a clinician or rehab clinician who can perform rehabilitation exercises or activities that can resolve the impairment. And so if you have a you know, working memory deficit or you have a visual problem, you know, you're going to see a certain specialist for that problem. If you have a vestibular problem, you're going to see a specialist for that problem. If you have a headache or you have you know, symptoms are related to sleep deficits, or mood disorders. see different rehabilitation specialists for those types of things. And so the key is now, we ultimately are recognizing the value of phenotyping, these phenotyping concussion because the value of getting the person to the correct rehabilitation specialist is ultimately what is going to improve the patient outcome, right. Rather than having these people walk around for years and years and years after their concussion injury with all these deficits that they just have to live with, because we've not managed them properly. And so that's what I always tell people don't go to the emergency room see a neuro specialist in your area that specializes in concussion, and make sure that that person is getting you to a neuro specialist who performs the rehabilitation based on the type of problem that you have.
Patrick Kothe 35:42
I think the other thing that you mentioned, it's equally as important, you said that you have to identify what it is. But you have to also have to have something that's measurable. And that's where kind of devices are entering here. So let's let's talk a little bit about devices. Because in the past what's been used with the most commonly used product for concussion, diagnosis, and monitoring has been the impact test or a computerized test, where you do a baseline test, or the the athlete or person in the military does a baseline test they have, they have to sit down and try to take a test. And then once they have the injury, they try to take that test again, and trying to take a test. It's not like a blood test, or it's not like an x ray, where you can say this is definitive, it's one way or the other. If you if you have to force somebody to try to do something for whatever reason, it's not going to be a real valid test. Either that either the person said, I want to make sure that I dumb this thing down on the baseline. So I can I can play again or anytime that you have a have that entering in it's not a valid test. So it has to be measurable. It has to be something that's that's, that's valid.
Scott Anderson 37:00
That's correct. And I think, you know, really the metric that I think a lot of clinicians look at is test retest reliability, like how reliable is the test from one test to the next, right, because if you're doing a baseline test before and doing it after injury, if it's not reliable, then what you're looking at is going to be you can't make a decision based on that information. And so I think, you know, that's really, you're correct. The impact test has been around since the 80s. It was developed based on the actual neuropsychological battery that a neuropsychologist utilized in the care of the Pittsburgh Steelers players during that time. And it was made into a digitized format that could be done on anybody. And it was the large it was, in large part, the most heavily studied type of concussion diagnostic tool that we had in the market for 30 years. And so, you know, I think people were drawn to that, because they had no other choice, right, there was no other option in the marketplace for people to understand how to do concussion assessment, which was other than to do neuropsychological testing.
Patrick Kothe 38:05
And the other thing is it was relatively inexpensive. So you could test or you could test all of your high school athletes for you know, 1000 $1,500 you buy a package, and and you could monitor them all through there. But the results have not been as good as what people thinks think that they're getting when they're taking taking that test. Yeah, I think one of the other things that occurred when we talked about that mass hysteria time, you know, 10 years or so, eight years or so ago, were all everything was coming out. All the CTE and information, everything. You had a number of other technologies that were coming out some apps that were coming out saying, hey, diagnose a concussion at home, there are accelerometers that people were putting inside helmets inside mouth guards to say, hey, if I if I get, you know, X amount of G forces on this, and there may be something going on, and mom may have an app on her phone monitoring, you know, Jr, when he's out in the field and pulling him off the field. So there was a whole lot of different things that were headbands. I'm gonna, you know, I think I don't know if Russell Wilson is still still reppin his his, his water for for preventing concussions, but there seem to be a lot of different things that we're chasing after the technology. But they I think that's kind of shaken out a little bit. Is that Is that accurate?
Scott Anderson 39:30
Yeah, I think so. I think, you know, what, what we've realized is, well, I think a couple things. One is, you know, there's there's no substitute for good science. And I think many clinicians understand that and I think, you know, people are able to tell snake oil from you know, real, scientifically validated, incredible, you know, technologies and I think what people have realized also is that now that we have these measurable these subtypes are these phenotypes that we've identified as being the most prevalent, that we need objective information to help us make the diagnosis because we can't get the patient to the right provider to fix the problem if we don't, if we don't have any way to indicate what the actual dysfunction is. And so I think, to your point, you're 100%, correct. There's, you know, apps that are, you know, having you play video games are only going to do so do so much in terms of getting you to, to understand where the deficits are, they're not telling you how to correct them, you know, unfortunately, and I think, you know, concussion has always been about what's the most cost effective way to get me my answer. And because it's the brain, and you can't see it, nobody knows if that answer is right or not, you know, and I think that's been the challenge is that, you know, without objective information, how can you prove what you're telling people is actually, you know, what they should believe? And, you know, that's, that's when the real tricky thing, I think that test retest reliability with a lot of these technologies have been extremely low, means that whatever they're collecting is not valid or not, you know, not really reliable information. And, you know, we shouldn't we shouldn't be incorporating them into, you know, concussion management if clinicians are gonna make decisions based off that.
Patrick Kothe 41:14
I think what, you know what you said earlier, the clinicians, this is a very complex, multifactorial decision that they're making. That's right, and every patient is different. And experience is very important in this space as well. But what clinicians have historically wanted is give me some objective pieces of information that I can base my decisions on, and then I can I can track that patient. Because there's two things One is there's the identification, is it a concussion? Is it not a concussion? And what systems are affected, so that I can build a plan to put that together. But then there's also what does the return to play decision look like? I need to monitor that person to know that they're getting better, and it's safe for them to go back. Because if you go back too soon, there's some bad things that can happen to people go back back to soon, both short term and long term for that for that patient as well. So let's talk about sick think, and what you guys are doing to have a more objective type of piece of information that clinicians can use to to diagnose and monitor their patients.
Scott Anderson 42:28
Yeah, I think, you know, same thing is, I think, I've been a pioneer in some respects, in terms of developing a new type of technology that not only is used for concussion, but other types of neurological conditions to as well, that really is, you know, I think, one of the first technologies to bring objective information to neurological conditions. And I think, what's exciting about I think our product is that we're leveraging the only part of the brain that you can see, which is your eyes. And, you know, it's it's really, really compelling information that you can capture eyes movements, and that we can determine whether or not someone's brain state has altered as a result of the way their eyes are being moved by the brain. And we can do that in a really reliable way. And so, you know, we spent a good portion, our founder, who's a neurosurgeon has spent a good part of, you know, a decade and a half studying this, and being able to capture eye movements in a repeatable way, so that the information that we collect from my movements is reliable. And we, you know, essentially implement an algorithm or a series of algorithms that allow us to quantify what your eyes are doing and how well your eyes are moving the brain. And we provide a a extended reality headset, or like a VR device that goes on the patient's face. So they're, you know, basically in a contained environment, and we utilize a sensor that's inside the goggles that records and captures what the eyes are actually doing. And so over the life of, you know, the studies that we've done, we've been able to show that there's a very specific type of eye movement signature that occurs in patients with concussion. And this tells us that they have a change in their brain function. And it's specific and specific only to this condition. And there are other eye movements, signatures that are associated with other types of disease and pathology as well. But this is a unique, what we think is a biomarker for concussion, you know, it's something that can be done in a non invasive way, and a very simple 62nd assessment that can give you a lot of really good information, a lot of hard metrics about what your eyes are doing and whether or not your brain is moving them the way that they should, or we the way that we expect them to and whether or not your brain is acting as if it should under those circumstances. So, you know, it's a really interesting technology. I think it's a little bit ahead of its time and respects because people are, you know, oftentimes like, wow, you can do all that already. And, you know, I think people are just realizing the potential that exists and I movements in terms of understanding your eyes being a window into the brain and understanding more about how the brain operates through what your eyes are actually doing.
Patrick Kothe 45:18
Scott isn't specific to concussion I mean, does it differentiate between mild TBI and, and severe TBI?
Scott Anderson 45:25
It does, it does not it's specific to concussion, we are looking at we are measuring the the neural network activity, we're telling you how well your brain is able to process information. So I'll give you an example. When you are looking at something that's in front of you in the visual in the world around you, your brain is constantly using your eyes to give you information about what's happening around you so that you can interact with the environment. This is how we experience space and time, you know, things are happening around us, we move our eyes so we can see what's going on. If a ball is coming at my forehead, I need to move out of the way. So I have to be able to move my eyes to the ball, recognize that it's coming towards me and get out of the way before it hits me in the head. Or if someone's walking up to me with their handout and they want to shake my hand they have to recognize that's what they're doing. And I have to repair the sensory motor system for a response, I'm going to stick my hand out and shake them back or they say hello to me, I'm going to say hello back. All this is based on visual information. It's how we pay attention to the outside world, and how we experience life. And our eyes are responsible for doing that. But what a lot of people don't know is that our brain is actually moving the eyes to help us figure out what's going on around us so that we can preserve our life, right. And initially, it was used for us to like Oh, see, see bear running after me or a lion running after me don't get eaten run away, right. And now we've got like, Okay, I could safely across the street, or, you know, I should put my glove up and catch that ball, because it's going to hit me in the head otherwise. And so we've adapted, obviously, over the, you know, over the centuries of of how, you know, human has evolved, but the premise is still the same. And we this process of visual processing, or you know, sensory motor activation is something that we get really, really good at, by the time we're teenagers, we have a way of practicing interacting with the outside world 1000s and 1000s of times a day by moving our eyes. And so we get very, very good at doing that. And so when we are in an altered state, like having a concussion, we don't do that at all. And we don't experience the outside world at the same way in the same speed. And we don't move our eyes in the same way that we should. And there's a change in the way that our eyes are being moved by the brain, which tells us that something is off. So this is essentially how we can identify whether or not you know, this is the result of injury or not. And I will also say that there are numerous other neurological conditions like ADHD, dementia, Parkinson's, schizophrenia, vestibular disorders, like vertigo, and vestibular neuropathy, and autism, that all have I've movement abnormalities associated with it and have over, you know, most of them have over 40 to 50 years of publications supporting the evidence behind abnormal eye movements associated with these conditions. And we have just traditionally only relied on the patient's information to make the diagnosis. But you know, that's the mission that we're on as a company is to really bring icing to neurological conditions and to use eye movements as a metric for these types of conditions and the abnormal eye movements that occur in each of these.
Patrick Kothe 48:42
So as you bring a technology like this, and there's a regulatory some regulatory choices that you're right, you've got in terms of your labeling and claims in there, you could take in and say this is a diagnostic tool for concussion, you could say that this is your monitoring, neurological function, you could do a take it a lot of different ways. And the proof sources are going to be different. But then if you don't have a claim, then you're trying to mark it into into an area where a claim would be really nice and really beneficial. So how did you guys approach approach your your labeling and claims that you're going to make?
Scott Anderson 49:22
Yeah, that's a great question. I think, you know, the way that we've approached it is that we recognize the larger kind of abnormal eye movement market opportunity. And so when we were first commercialized in 2017, we we pursued that and our initial clearance from the FDA was looking at essentially that right, which was we were cleared to view, analyze and record eye movements in support of identifying abnormal eye movements and human subjects. And so anything that where there's evidence supporting and we're clinicians are utilizing eye movements to make diagnoses are technologies being utilized for that, as we have grown as a startup, we've developed additional, I would say pathways for different products. And there are two things that have happened kind of simultaneous to each other. One is that we have continued to, I think, evolve the technology and to, I think bring a more robust solution to the marketplace. In the early days, when we were doing, you know, studies prior to our initial clearance, we were making our own devices and building our own sensors to put into the devices. And a lot of these, this core functionality is available on, you know, consumer enterprise, virtual reality and augmented reality devices that are on the market today. And so we have one path that's telling us, oh, the actual hardware technology is catching up to our, our software and what we actually do, and there's a way for us to become less hardware specific and more software agnostic or, you know, device agnostic, I would say, and allow us to, to have different solutions for these different use cases. And simultaneous to that we have to validate those through clinical trials, you know, under these different conditions. And so we started with concussion, and we had significant study efforts to go underway to look at, you know, the efficacy or the accuracy of our system at being able to detect this abnormal eye movement under these conditions. And we recently received an FDA approval in October, that allows us to now use the technology as a diagnostic tool, we're the first FDA approved diagnostic tool that can be used both for a positive and a negative diagnosis. So being able to give you a thumbs up whether or not we believe that that abnormal signature in their eye movements is there, and that they have the presence of the condition. And ultimately that you know, identifying whether or not they don't and and that the signature is not there. And we are going to replicate that approach for different use cases for different hardware devices. So, you know, we may have a concussion specific technology that comes to the market that is, you know, solely based on a certain type of form factor that has a very specific type of sensor in it that's utilized for concussion. And when we were in the process now of doing ADHD, clinical trials, and that's an ongoing thing for us too, as well. And that may be a different device with a different type of clinician workflow based on what the clinicians are telling us that they need, as part of the the diagnostic routine for diagnosing this condition. And the same is we're going to have another study kicking off in the first quarter of next year too, as well, on a different indication. And so we have, we're kind of going down the path of getting additional, more specific indications for use for these different use cases where we feel like there's a significant market opportunity with a potential significant hardware partner that we can work with to, you know, bring a solution to the market together really be the first ones to bring objective information to these use cases. And a lot of times we're, you know, people are still diagnosing these conditions on on symptoms.
Patrick Kothe 53:07
Scott business model wise, do you need baseline studies for the for this technology?
Scott Anderson 53:13
You do not know, we have the largest Yeah, we have the largest eye movement database in the US or in the world? I mean, and we can draw from our database in order to make comparisons to to normative data.
Patrick Kothe 53:25
So the product is a post injury product. So
Scott Anderson 53:29
yeah, it can be used at the point of care. post injury, yep. To make the diagnosis, correct. It can people can people do use it as a for baseline testing, if they, if that's part of their workflow, it can be done as a baseline measure as well. But I would say the majority of our users don't do baseline testing.
Patrick Kothe 53:48
So this is for clinicians, schools that are going to be using this as as, as their tool, their postinjury tool is, are you selling it, leasing it,
Scott Anderson 54:00
I would say the business model is exactly like a cell phone plan, you pay a certain dollar amount up front for the hardware, and you get the hardware over a three year period. And over that three year period, you pay a license fee for the software, and you pay that on a monthly basis. And so we have a kind of a what we call a combined hardware software bundle that we package.
Patrick Kothe 54:23
Scott, I'm really excited for you and the company and and the clinicians, that that are going to be using this technology. It's it's been a long time coming to have something that is truly useful to help provide information that is objective. And I'm really, really excited to see you guys kind of where you are. So kind of looking off into the future. What do you see the you know, kind of where we are today what the state of the art is today. What's the future look like for you and how do medical devices fit in? To this, this this new future?
Scott Anderson 55:03
Yeah, I think that's a great question. I actually a really exciting time. And there's really this convergence of digital health, medical technology, medical devices, and consumer technology all coming together in one place. We're seeing consumer devices like VR and AR use for enterprise and healthcare purposes. And it's because they're being equipped with the type of sensors and functionality that enable additional value to be provided to people like patients. And so I think that's going to be a huge thing that happens over the next five to 10 years is we're going to see continued convergence of the the medical slash healthcare space intersecting with the consumer space, just like, you know, you're on your Apple Watch. And you can take your own heart rate, and you can send it to your doctor, and you can, you know, have an EKG and you know, so there's all these consumer devices now that are coming with health care purposes. And I think that that's going to continue to be the case, with respect to eye movements and our area specifically, we know that this is already, you know, the first device came to the consumer market in 2020, virtual reality device that had eye movements, eye tracking sensors built into it, I think eye tracking specifically is going to be a huge part of the future. For augmented reality, there are already companies that are making daily wearable contact lenses that are augmented reality based and can give you insights into you know, you're going on a run, and it's telling you in real time, how many calories you've burned, you know, just sitting on your eye and tracking your eye movements and telling you what you're looking at, and zooming in on to things and giving you a better view of that based on what you're looking at. And so I think there's this real and you can imagine the consumer applications, you know, just for that, you know, aside from what we would use it for, so, I think you're gonna see things like, you know, Apple come out with a smart glasses and other types of devices that are for consumer use, that are going to have sensors for eye tracking, that will allow us to do this without, you know, really having a product who will just live natively on their phone or on their watch or, you know, on their glasses. And, you know, they can just do it themselves and send it to their physician and the physician can tell them what the problem is. So really excited about the future potential of this. And no, I I'm a huge believer that technology is meant to improve people's lives, I think it's no more apparent for for neurological conditions that patients get access to technologies that really can can help them manage their conditions, first correctly diagnose them, but then also helps them manage the conditions across our lifespan. So it's, it's, we're really on the edge of that happening. And it's a really exciting time.
Patrick Kothe 57:51
A big thanks to Scott for such a great update on how the field of concussion management has evolved. A few of my takeaways, first, the importance of challenging conventional wisdom. You know, concussion has been around for a long time. And we all have our thoughts about what what it's all about. And a lot of it is probably outdated thoughts. So when Scott talked about research and data driven, and really, really looking at things, he's talking about challenging conventional wisdom, but that also means it's the public, but it's also clinicians and clinicians need to continue to do that as well, and be open to new learning. The second thing was product claims, and I thought it was particularly interesting when we were discussing sink thinks entry strategy or market entry in terms of claims, and then how they've expanded those claims going forward. A very interesting thing too, for all of us to keep an eye on is how are we getting into the market? And what claims we need to have? And then how are we going to expand? And what claims we're going to need for that? And finally, what business are you in? Sick think has got a hardware and software component, but perhaps in the future, they can farm out that hardware component out to somebody who's doing that better than what they're doing, but still maintain the software and the data analytics and the predictive analysis portion of it. And that becomes the product so really, what business Thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the mastering medical device podcast wherever you get your podcasts. Also, please spread the word and tell a friend or two to listen to the mastering medical advice podcast as interviews like today's can help you become a more effective medical device leader. Work hard. Be kind
