Leslie Prichep, PhD, the Chief Scientific Officer of BrainScope Company and a Professor of Psychiatry at NYU School of Medicine talks about the hand held BrainScope device, how it works, and how it can be used by a variety of people.
Interview conducted by Ivanhoe Broadcast News in December 2017.
Tell me about your background.
Dr. Prichep: Together with my late husband E. Roy John as co-directors of the Brain Research Laboratories at NYU School of Medicine, we were pioneers in the field of quantitative electrophysiology which is the field that allows you to quantify the brain waves in to characteristics that describe it. Very much like EKG does for the heart. Doctors can look at your EKG and know how your heart is functioning. We can look at the brain electrical activity and know how the brain is functioning.
With that as context I wanted to start by asking you a little bit about BrainScope. What it is, what the product is and what is it designed to do?
Dr. Prichep: BrainScope is a neurotechnology company. We have developed a first of its type hand held medical device, BrainScope One, that allows for a rapid assessment of the full spectrum of traumatic brain injury. And it does it in a hand held device in real time and gives an output to the clinician, to the user and to the doctor, that helps him in his assessment of that brain injury by providing an objective biomarker related to the impairment in the brain.
You mentioned hand held, why is that important?
Dr. Prichep: When you’re focusing on the acute phase of an injury, we’re looking at the first three days following the injury, we’re really at that very first point where decisions have to be made by clinicians about what’s the right path for this patient. There’s a great deal of data in head injury that says that the quicker you can identify a brain injury the less the short term and long term consequences, so it’s very important. That’s that juncture that we’re jumping in to. So we need to be able to be portable, at the point of care, and need it to be able to be done rapidly. BrainScope takes advantage of the advances in technology, that lets us record the EEG on a ruggedized cellphone, and extract the characteristics in real time. So for it to serve the purpose to aid in the diagnostic chain that we intended, we need it to be small, portable and available at the point of care.
Can a clinician or someone using the BrainScope get an immediate yes or no this is or is not a concussion? Or is this a step towards something else?
Dr. Prichep: The information provided by BrainScope One can be a core component to aid in that clinical diagnosis. The device itself is giving an additional piece of objective information by providing a biomarker about the likelihood there’s a structural injury. Something like a bleed caused by the head injury. Or a functional injury much like seen in concussion. So what we’re providing is not the diagnosis but an adjunct to the diagnosis that can become a central component. Its objectivity is what makes it unique. And what we’ve also included to make it easier for a rapid clinical decision on the part of the clinician is a full set of additional assessments that are the standard assessments used today. But now the clinician doesn’t have to go from the BrainScope and get out another computer and have the patient do a neurocognitive test; they’re on our device. In addition, BrainScope provides digital forms of all of the standard assessment tools on the device. So in the end the clinician can rapidly see a panel of results from all the assessments they’ve performed on the BrainScope device, much like a blood panel.
You had mentioned this is objective rather than subjective. Is there subjectivity now when it comes to diagnosing a concussion?
Dr. Prichep: Very much so. In fact, disturbingly if you look at what is the standard of care today it is almost entirely based on subjective report: self-report of signs and symptoms. And there is no gold standard for concussion. So it’s very much based on the presence or absence of symptoms. And now you take the star football player who gets injured and pulled to the sideline and asked how he is, he’s fine because he wants to go right back in to that game. And you have no way of knowing without objective tools like the BrainScope One device. Whether or not there is actually an injury to the brain today is based almost entirely on subjective report.
Is this designed to be a precursor perhaps to a full battery of tests to a traditional brain scan or something that’s now used to diagnose concussion?
Dr. Prichep: That’s an interesting question and it’s important because right now the standard of care for a head injury, if you go to the emergency department, is a CT scan of the head. The CT scan is performed in approximately eighty five percent of those head injured people who walk in the door of an emergency room. Most of those of people, the vast majority, over ninety percent of them, are found to be negative. So right now it’s done to exclude the possibility of a bleed because there’s nothing else that can help you to access the likelihood. BrainScope One doesn’t replace the CT scan but what it does is give you an additional piece of objective information about the likelihood that individual would be CT positive. As such it can increase the provider’s confidence in making a decision not to scan, by providing an additional unique piece of information that can help them in making that decision. On the other hand when you go to the emergency department, once they’ve ruled out the possibility of a bleed using a CT scan, the entire rest of the brain injury spectrum of pathology, other ways your brain could be impinged upon, is not assessed. They have ruled out the bleed but there are no tests that are done there in the emergency department for mild TBI or concussion. BrainScope One would allow a more informed referral on the part of the emergency physician and other urgent care settings, providing objective information about the likelihood of brain function impairment,.
Can you walk me through how this works?
Dr. Prichep: Sure. It is based on brain electrical activity in the frontal and frontal temporal regions of the brain. Recordings are made using a disposable sensor array (or headset) that is placed right across the forehead extending to the sides of the forehead. The fact that it’s on the forehead makes it easily accessible and easy to put the sensors on the head. The headset records the brain electrical activity; which goes directly in real time into the hand held device and the programs, the analytics, the revolutionary technology that BrainScope has leveraged in processing these electrical signals then take over. The characteristics of the EEG are automatically extracted by the programs on the device and become the inputs to the sophisticated algorithms that are in the device. The output of those algorithms are immediately available to the provider in the form of the result of the test; is this likely positive on CT or advanced neuroimaging, or likely no injury visible on CT (negative). And is there likely a functional injury component to the impairment. BrainScope One is intended to be used in head injured patients 18-85 years of age, who are mildly head injured and evaluated within 3 days of injury.
In terms of the person administering the test, how do you envision this working? Could it be easy enough for a trainer, is that what it’s designed for? Somebody who is right there on the field on the sideline?
Dr. Prichep: It was incredibly important to us in developing the BrainScope One, to create a device that could collect quality information and that it could be collected by anybody who sees the patient at that initial point of care. The user is intended to be any level of medical professional who is under the guidance of a clinician. So the clinician can order this test but now the person that can do it, for example in the military it can be a medic, it can be a physician’s assistant, it can be anybody who has access to the patient at the immediate point of care. In the sports arena it will be the athletic trainer, or the like. In the urgent care center it might be one of the radiology technicians. It is designed to be rapidly learned. A two hour training session which BrainScope provides brings people up to speed in how to use the device and how to place the headset with the sensors. But equally importantly we hold the hand of the user the whole way. For example, the headset that has the sensors on the forehead is labeled in a way that has little pictures of where it goes. It’s designed in a way that is hard to get on wrong. It’s going in to the right place by design and by training. Next is it has to make good contact with the forehead or else the quality of the electrical signal can be compromised. So what we do is we tell the user as they’re placing the headset exactly how good that connection is. And if it isn’t good enough it won’t collect the data and they have a chance to fix it.
How does that happen? Is it a sensor that goes off if it’s not on right?
Dr. Prichep: Yes. You’re placing it on the forehead and you’re looking at your hand held device, where there is a picture of the head and a little color coded circle for each location. And that sensor is green, yellow or red depending on how good your connection is. We’re aiming for green. You can collect with yellow but you can’t proceed if any sensor is red. So it’s telling them right there and then. And if it’s red they just lift up that sensor, re-prepare the spot on the forehead, maybe wipe off a little oil with an alcohol pad, and then press it back down and see if no longer red. We also monitor that connection throughout the whole data acquisition. So, if they start out good but something comes off it stops them and it shows them where. In addition, one of the things that can slow down the data acquisition is muscle movement, like somebody blinks several times. The electrical activity of a blink is much larger than the electrical activity of the brain. If you’re blinking or furrowing your brow and there’s muscle involved that the user can give feedback to the patient and improve the recording. It’s not required to be totally still or not blink. A dashboard on the device helps guide the user when artifacts are present so they can give feedback to the patient. Using this information the user can say to the person, try to hold your eyes still it looks like you’re blinking. What the company has done internal to the BrainScope One device is to provide a number of automatic measures that give feedback to the user that they’re collecting good data and maintain high quality recordings.
Can the trainer or whoever is using it, clinician or medic look on that cell phone screen and are they able to read, is this something that they could see, if this needs further attention or not? Is there something that shows on the cell phone?
Dr. Prichep: It does. There is what we call a dashboard screen that has a circle that shows you how complete your data analysis is. If the data acquisition stops there’ll be a light that flashes that will tell you what is stopping it. If its eye blinks and there’s a little picture of an eye and that blinks. Or there’s a little squiggle that tells you there’s muscle activity, or an icon if the patient is moving their head. So it’s giving them in real time the ability without knowing how to read an EEG to know that something is compromising the quality of the EEG recording. Now the screen also can show you the EEG traces if you happen to be a technician who knows what you’re looking for in the EEG, but we don’t require that, we don’t expect that.
What’s the bottom line for this device?
Dr. Prichep: The bottom line is objectivity; the bottom line is the ability to look at the changes in brain electrical activity when a head injury occurs. And to describe that as a biomarker that would add information for the clinician to aid in their evaluation of whether there has been a brain injury and what type of brain injury.
When you use the term biomarker could you tell me what that means?
Dr. Prichep: Certainly. A biomarker is a distinct pattern or measure that is related to the, in this case, the brain electrical activity that’s distinctive to brain injury. A biomarker is a biological process that can be characterized as being distinctive to a particular brain state or disorder. So in our case it’s a distinctive pattern of electrical activity of the brain that is indicative of the abnormalities seen in a traumatic brain injury.
We hear so much now about concussion and brain injury, why is a tool like this right place right time, why is it critical that there be something else to help a lot of these athletes?
Dr. Prichep: Currently, I believe the field would agree, concussion is a clinical diagnosis still at this point very much determined by self-report of subjective signs and symptoms. Objectivity needs to be introduced in to that process in a way that’s independent of subjective experience and related not just the injury itself but to the likelihood of persistence of that injury. Certain brain patterns for example, are associated with longer term recovery than others. The information provided by BrainScope is not available any other way right now, but integrated with the other clinical information can help the clinician make a more informed clinical diagnosis.
Benefit for the patient, is it in terms of just more accurate diagnosis, faster diagnosis? And you had mentioned much like heart it’s important to pick up early that there’s a problem.
Dr. Prichep: Very important. There is more and more recognition today and you see it in the media all the time, that there are both short term and long term consequences to head injury, including for example, CTE. And to the degree that the scientific community has been able to study it, it is clear that the earlier you make that clinical diagnosis the better the recovery period and the less likely the patient is to suffer from long term and short term consequences. Therefore, it’s very important very early on to know what you’re dealing with and to then plan a clinical course that recognizes that. If we know, for example, that there’s still some abnormality in the brain and that they would be subjecting a brain that hasn’t healed yet to the potential of another hit or injury it would be very important information to have in making decisions about return to normal activities. Currently, there is no objective way to know. On the other hand if they had broken their ankle and there is still a break seen in the x-ray there is never a question about whether they should go back to play or not. With the addition of information that can be provided by BrainScope there is objective information to be added to the clinical determination of “recovery”. And I think that that’s something that is important to the parents of young athletes, to professional athletes, young adult athletes. And to anybody who in any circumstance sustains a head injury.
Is there a difference between a brain that is injured, the way the electrical patterns are moving and can you describe that for me?
Dr. Prichep: When somebody hits their head it changes the brains electrical activity pattern. And it can change it in many, many different ways that are associated with the type of the traumatic brain injury. Is this likely reflecting the presence of blood in the brain? Is this reflecting changes in the way two parts of the brain talk to each other? How that neural activity goes from one area to another. That’s called connectivity. The abnormalities that occur following a head injury are reflected in characteristic changes in the brain activity. While no one of these changes would describe that abnormality through the use of the sophisticated algorithms methodology that the BrainScope One implements, the set of changes that are distinctive of a traumatic brain injury can be identified. And it in that way is providing unique objective information.
Is there anything I didn’t ask you that you would want to make sure that our viewers know?
Dr. Prichep: I think there are a couple of points I would like to mention. One is that the evolution of the development of the BrainScope One has occurred over a ten year period of time. During that time BrainScope has had a very active and important partnership with the Department of Defense with seven contracts that were executed in time and made meeting all of their end points. There were four FDA clearances culminating in the BrainScope One clearance in September 2016. During the period of the development our independent investigators at our clinical sites together with each other and with the information provided by BrainScope on their studies have published twenty three peer reviewed articles that talk to the clinical utility of the device, the usability and performance of the device. The ability to see both structural and functional abnormalities is critical to the functionality of BrainScope One, achieved through commitment on BrainScope’s part to have a multimodal approach to assessment. At its core BrainScope One includes the EEG components but also provides the other clinical components that we talked about which can be configured to use on the device to further support the clinical assessment. So each clinician can decide what’s optimal for their use. That’s unique. I think those are the really main important ones. But I think the objectivity, the portability, the use at the point of care, the immediacy of results being available are all unique to the BrainScope One were important to our mission in order to create a device that was going to be able to be used at that important juncture. And I think that we have demonstrated that BrainScope One addresses that need uniquely.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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