Could Severe Tinnitus be Cured with a Brain Implant? Promising Technology Under Development

[Music] welcome to this week in hearing ohello I'm Bob trainer your host for this exciting episode about a new European orientation to severe tiitus uh by a company called neurosoft bio Electronics a company that uses Ai and machine learning and some of the things we're on the verge of here in our profession uh for the treatment of severe tinitus today my guest is Nicholas vurus who is the CEO of neurosoft bioelectronics and uh thanks for being with us today Nicholas and we're really excited to hear about your new product that that may be uh able to to work with us and are patients that do have severe tenius nice to meet you rob Bob and thank you for having me here today good well uh so the first thing I like to do with with these sessions Nicholas is you know um how did you get into working with tiitus patients and how did you get into into this area where you've come across this bi neurosoft bioelectronic system yeah so my background is actually in microelectronics and Nano systems so this I'm a more like engineer in background I did my studies uh in Switzerland and actually during my studies I one of the first project I did as a PhD uh in our field was around a hearing actually and I was in um in Boston for one year where I did my master thesis it was still about bil electronics and I'll tell you more about it but it was in a specific case of what we call auditory brainstem implants so these were device to provide hearing Sensations to patients who can are not candidates for C implants so it was not tenus back then it was more on the hearing but it was the first and the main project I did doing my PhD so I was actually at Mass ear infirmary with ENT and neurotologist so that's how I got into the let's say ENT field and when we started a company and I'll tell you more about it but we're developing these brain interfaces um to record and stimulate nervous system and we were looking into different indications that we could help and during that time there was a study ongoing um at epfl for the University that was sponsored also by the V Center Foundation here in Geneva that was about severe tenos so they were looking into functional MRI into very severe cases and trying to to to look at the brain of these patients so we got curious about citus we looked into it and we realized it was a huge onmed clinical needs and uh by talking to some patient associations patients ENT neurologists we realize that there is potentially something that we can do about it with our technology fabulous and and we all know that um that some of the most Innovative things come from uh from individuals with different training that we have and working with our patients and we put all that together uh with what we know about the patient so what we know what what some of our our our new colleagues know about all these other things that we never studied in ever so so uh so why hasn't there been a treatment for severe tenes or what we often call bothersome uh sustained tiitus uh and again you know we we may see one of these patients every couple of years but when we see this one well it it just it just drives us uh nuts try to figure out what we're going to do how we're going to take care of those guys and what what kinds of things they need to facilitate uh a movement back into the normal situation yeah that's a good question so as you probably know tenus in general with all considerations is a a huge uh problem worldwide I think it's around 15 14% of the world population and as you mentioned we're focusing on these very small but still large subset of patients who are very severe so chronic and debilitating which is about 120 million people worldwide and what what I'm learning also as I got into this is that it's actually a very heterogeneous population so you have very different causes for the tenus it could be viral it could be noise exposure which I would say is the most common and you know we even seen coid had increased uh you know tenus um incidents uh so there's different things so I think that's one of the reasons is that it's not only one disease or disorder it's really something that can be caused by multiple aspects so obviously you're not going to treat patients the same way depending on what's the the root cause and I think the other bigger problem as you probably know is that there's limited understanding of the precise mechanism that causes tenes so there was also a lot of work actually that was done more recently that guided us towards what we believe could be a good solution but it's still something that is relatively not understood and I think the last element is that it's a very subjective Disorder so it's very hard to measure you probably aware of all these scales and you know uh try to ask patients how they feel about it so when you don't have a very precise quantitative method to assess it it's hard to know if whatever you're trying is actually have a having a clinical impact or not so I think these are the different elements that make it that there's today not treatment okay well yeah and uh and that's always been an issue the subjectiveness of the has always been an issue whether whether it's something that was created by an accident or whether was something was created by certain kinds of noise exposure or other kinds of things it's always been an issue so what kind of a product are are you presenting to the uh to those of us that would be treating tinitus patients uh Nicholas so it's still a early stage project but uh as I mentioned earlier I got interested at in the field of what we call bilonic interfaces so these are implantable brain devices that can interact with the human brain so these are electrodes that can either read or write into the brain so they can be used to record or stimulate electrically and that's something that is not new I mean it has been used actually to help patients with Parkinson disorder to remove symptoms it has been helped for patients who have Spa cord spinal cord um back pain to stimulate the spinal cord and remove relieve the pain or coar implants I think think are a very good example of how electricity has been able to provide auditory Sensations to patients so this is the field where we're at and at neurosoft we developed a new type of electrodes that are much thinner they're much softer so they are actually much safer to to use and uh they are able to um record and stimulate the human brain and So based on some of the more recent uh studies that were performed with tetus understanding the mechanism of action what we have realized is that a lot of these severe cases this is not only a problem in the ear but there actually underlying issues within the brain where you have hyperactive networks um and again this can change across patients but there's really in a lot of these patients have issue at the level of brain so the idea is to try to the same way people are able to stimulate the brain to remove symptoms from Parkinson's to try to uh rechange these pathological networks through electrical stimulation and recording to help these patients so that's in a nutshell what we're trying to do okay so now you've been been doing some human testing with your products uh recently I guess and uh can you tell us more about that and uh what it really means for for the efforts of working with severe tenis patients yeah this a very good question so obviously we are working with very Innovative and new technologies so the first thing we wanted to do is to demonstrate just the ability of our devices to function within the human brain so for example to record human activity so until now we've done a lot of animal testing to demonstrate the safety and we arrived uh this summer at a point where we were ready to test it in humans so we did it in a very different condition it was for epilepsy patients or brain tumor patients where we have uh let's say easier access to the brain during surgery and we were able within a few patients four so far to really just test the ability of our device to record from the human brain in a realistic environment so for us it was a very meaningful Milestone just to demonstrate it was not about tenus this one but really about the safety and the effectiveness of our device to interface with the brain so that was really the one of the first Milestones before we go further towards thus okay so so what's so special about this particular electrode I mean I you put electrodes on AB people all the time and back in the old days we did E ands that we put put electrodes around the eyes well what's so special about your particular electrode that makes it different from the electrodes that most of us know and love because of our uh because of our assessment techniques yeah that's a good question so the motivation behind our work comes from the observation that the brain and neural tissues are very soft so you can think of it like spanak Cota or tofu and the problem is that bons recently the best way we had to interface with these tissues were with very rigid Electronics like hard metals and they didn't were not very well accepted by the body so we had what we call foreign body reaction where you basically have scarring these devices push the brain they can compress it they can damage it so they were not great interfaces and so this motivated our work at the University and now with the company to really develop what we call soft electronic interfaces so materials are much thinner more much more flexible actually stretchable to make them in general safer but also to allow us to access brain regions that should otherwise not be able to because it would be too risky with other devices so this is really the main element is really about having a safer interface that has a bigger chance of surviving what what we call the very harsh environment of the brain because you have a lot of liquids it's in movement it's soft you have tissues there's a lot of happening so that's the first main element the other one is we have sensors on these electrodes so these electrodes can record and stimulate and today a lot of these electrodes are relatively large so think of a TV screen with a few pixels you won't get a very good image of what you're looking at uh so we're able to have lot smaller and much closer together electrodes to get a better picture of the brain and on the opposite direction if you're stimulating having smaller electrodes allows to stimulate more precisely and to ensure you're not stimulating parts of the brain that you do not want to which might cause the secondary effects so these are really the two elements smaller electrodes and softer materials wow so so we have been hearing all kinds of stuff about Ai and machine learning's been around for a while but but probably not not in in things that we do very much so can you tell me how Ai and machine learning and these kindes of things work with within your solution yeah no a very good question so for us until recently if we look at the in general neurom modulation as we call it it's always been done what we call open loop meaning that the device is just stimulating the same region constantly and that's what it does and one of the big trends today in general and I think this will apply very very well to Tenors is to do what we call Clos Loop so this means that you're getting feedback so you're not only stimulating blindly but you're trying to understand what happening when you stimulate and try to use this information to tailor the stimulation so our goal is to have a device that can both stimulate electrically but also record the activity of the brain understand what is happening in terms of you can ideally find activity that is correlated to the level of tinitus see can we reduce it if so how we can use this information to better tailor the stimulation for every single patient and so this is where Ai and machine learning is very very useful because you can go a lot of data because imagine you have you know tens or maybe hundreds of electrodes that are recording continuously brain data that is very hard to interpret this is where AI machine learning can be a very powerful tool to interpret this information and to really tailor the way we will stimulate and and eventually treat the patients hopefully so that's how we're using it within this Clos loop system okay now um I don't know most of my t this patients aren't going to really de side they want to go have surgery yeah um so so brain surgeries are are are are still you know although they're much better than they were 30 40 years ago uh they're still a little risky these days and and how does the the neurosoft product um help make that a little bit safer for each and every patient that we would see yeah no that's a very fair uh question and so as I mentioned just earlier the fact that we're using the these softer materials is already a great way to drisk uh all a lot of the risk associated with these devices and I think that plays an important element and this is also why we're doing all these preliminary studies to demonstrate the safety of these these electrodes now one thing that we're quite excited about is that indeed the surgical approach today to implant some of these devices can require a big opening in the skull and so we're trying to leverage the fact that our devices are made of very stretchable materials so think of them like a rubber and what's nice is that you can actually fold it without breaking it and Def unfold it onto the surface of the brain through a small hole or a smaller opening and so this is something that we're trying to leverage because we're in a unique position thanks to the materials we're using to be able to do this folding on folding without damaging the electrodes and allowing us to do what we call minimally invasive approach and so this is really for us one of the elements we we try to leverage to make this also more appealing so it's not going to be like uh like acoustic neuroma surgery or anything like that it's going to be more like a a a very focused kind of a kind of an area where where do the where do the electrodes go do they go on H gyus area do they go in different other parts of the brain um so I guess that's kind of two questions for you there yeah no it's a good question and it's something that recurrently discussing exactly what and where we will be stimulating and this is something we're also doing with some of our advisers who have a lot more experience than us but indeed part of the parts of the brain that we're interested in are on it's all cortex so surface of the brain and indeed one of them is auditory cortex and we're also looking at the health chus in terms of access to other regions there okay so uh well uh and and I assume that you've done you were mentioning that you had some research at uh at mass ioner and some of the other places that uh had been going on then and and and you also I think said something about there were some some animal research first and then showing that that it worked and it did some things and then moved on into the human kind of uh kind of areas um do you see any the ethical kinds of risk with this uh brain technology that um as as we move forward with you know Ai and machine learning and surgery for tenus and things like that it's like who that's quite different than what we've been using over the last number of years with our ten patients no it's a great question and uh people are talking a lot about what they call neuroethics so it's an important topic that uh we we are faced with so indeed some of the concerns that I can think about with these devices withinus or in general are well everything that has to do with privacy consent uh and also obviously potential misuse of these devices so obviously one big part of what we're doing is when we are are doing our clinical studies for now for epilepsy and we'll start hopefully um soon for for tenus is to make sure that well we we ensure data uh privacy and ethical enrollement of the patients that they're well informed I think that's definitely something very important for us um and for potential misuse that's a bigger risk it's uh obviously try our best to make sure that device cannot be used outside of its intended use which is to treat patients um and we all stay aware of you know what's happening what are the um potentials of these Technologies but for now we think there is a lot more to gain uh with these devices uh not only for tenous actually but for a lot of neurological disorders and so these are some of the topics that we're keeping in mind and trying to think about as we're developing these devices okay yeah um I would think there'd be some some ethical things that that you'd have to kind of work through not necessarily uh then it's not ethical or anything it's just that that it is one of those thingses that when you have a new kind of a system you always have to work through some of these some of these esoteric types of questions that go along with it in ethics and that type of thing so so from so from where you are today Nicholas um where uh uh what are the next steps for neurosoft as a as a company and as a technology and that type of thing yeah so as you mentioned we started our first trials over the summer in Texas and for in the context of epilepsy and concretely now we're currently fundraising and with this fundraise we have uh two big objectives the first one is to bring to Market our first electrode for epilepsy uh and that's also even though it's for epilepsy I think it's going to be a great way to also drisk not only technologically but also from a regulatory perspective with respect to the FDA our device and then our big goal in the upcoming I would say year or so is to do a feasibility study for severe tenes so our goal is to start with a first smaller trial with a few patients just to test the visibility of this to better understand what works what doesn't to tune exactly how we're going to stimulate and um and I think that will be one of the Big M Stones we want to reach uh as soon as possible so how long do you think it's going to be before before if if I'm seeing a a severe T patient in severe TTI in a clinic how long is it going to be before I I uh I call up my neurosoft rep and the ENT and uh and figure out a way to fix that it's a good question it's a hard one just to give you an idea I mean it took us about four years and a half to go from our research environment to First in in epilepsy so you know we've done definitely some progress I still think it will require a bit of work and one of the reasons is even if we had a system that was working you know at least for regulatory approval you need uh data that is longterm so I would say at least one year followup so just because of that things are going to take time I don't have a definite timeline but I think four or five years is kind of what we're aiming for I think that's timeline to develop you know the technology do our feasibility study do what we call a pivotal study and get regulatory approval wow yeah so um now is this something that will be appropriate for hyperacusis as well it's a good question and we don't know yet it's something that we're going to monitor because because we know that there's a lot of uises in some of these patients um so I cannot answer I'm not completely sure it's definitely something that we want to monitor because indeed we might be surprised and we might see benefits uh in places that we had not thought about at the beginning yeah wow so so I I uh uh I I'm interested because you know having having always been kind of involved with tiis for such a long time the the idea first of all that you could do something about it and the late 70s was like Wow uh then we found different things that worked for different patients and but the severe tenis patient the severe bothersome uh individual has always escaped us and usually it's uh CBT or one of these other treatments that are out there um but they're still not not as efficient and effective as you would like um I I uh really appreciate your uh your coming into our discussion here at this week in heing Nicholas and presenting what is a possible beginning of the use of AI and machine learning and all of this is to colleagues out there a lot of this is coming from from individuals with huge backgrounds in other areas that bring their expertise into the problems that we see in the clinic every day so thanks thanks again for being with us Nicholas and uh we'll look forward to seeing more of you and your product uh as as it develops and so on so please come back to us here at this week in hearing and we'll uh well as the updates come out we'll update our clinical group about these things so so my guest today has been Nicholas vurus uh CEO of neurosoft bioelectronics a new company a European company but it's got some it's got some us interactions as well it sounds like um that is try to use Ai and rein learning in the treatment of penus be with us next time for this week in [Music] hearing [Applause] [Music]

2023-11-19 21:45

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