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PassW0rd – 11th January 2017

PassW0rd – 11th January 2017

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Speaker A: This program is brought to you by Resonance 104.4 FM. If you like what you hear and want to support our work, please make a donation at fundraiser.resonance.fm.

Speaker B: Hello and welcome to Password on Resonance FM with me, Peter Warren. In today’s program, we talk to the technologists who are planting tiny computers in people’s brains to cure disease and disabilities. The same implants These can also be used to endow American soldiers with superpowers, link people’s brains together to form a hive mind, or wipe out certain memories. But who holds the remote controller? Who decides whether it’s your granny who gets one of these innovative devices to reverse the effects of Parkinson’s, or someone else’s granny? And have the law and ethical standards kept up with the pace of technological change? Medicine and remote diagnostics are being seen as the next big growth area of the 21st century, and biomedicine has been identified by venture capitalists as being at the heart of that trend. Last year, GlaxoSmithKline and Google formed the £584 million company Galvani Bioelectronics, a joint venture that is being supplied by Will Rossellini’s Nexian with devices for its internal research. It’s a fast-moving area, with Nexian itself completing an oversubscribed round of funding in November. Of course, none of this is exactly new, as Will Rossellini points out.

Speaker C: Greeks had people step on eels to cure pain, you know, thousands of years ago. So the idea of using electricity as a therapeutic reality is quite old. The pacemaker is a wildly successful neurostimulation device that was invented in the 1950s. And I think there’s over a million people with implanted devices with a pacemaker today. There’s the cochlear implant that restores hearing. Then there was the spinal cord stimulator that alleviates low back pain, a vagus nerve stimulator that alleviates epilepsy.— So what the field has been is primarily putting electrical charge into the system and changing the function of that system with what I consider very crude parameters or an on-off switch. What’s happened, I’d say, in the last 10 years is that we figured out that you can apply an on-off switch to the nervous system on any nerve. So there’s now, I think, over 20 companies developing this technology for different nerves, different applications like sleep apnea or asthma or migraines. And then the other part of this is the first— this is the first time a pharmaceutical company, so GlaxoSmithKline, has said that they’re going to create medicines using what they’re calling bioelectronics. So, so they’ve come in in a major way to say we’re going to control end organs, meaning organ function, via the nerves, and doing that the way that the pharmaceutical companies think about development. So it’s kind of a— call it the second era of neurostimulation.

Speaker B: But Professor Nada Kakabadse of Henley Business School warns there are dangers.

Speaker D: I think that development should be more moved to better quality of life than what it was 5,000 years ago. We should evolve to the more human society. We should be more concerned with others. After all, what is ethics? It’s how we treat others, isn’t it? Anybody, and others is anybody who is not ourselves. So it could be other humans, animals, environment, etc.

Speaker E: That’s an interesting point, isn’t it? You raise animals. I’ve had a microchip implanted in my dog. I don’t get a £1,000 fine. Can you foresee a day when it might become desirable for humans to be tagged in this way?

Speaker D: Certainly, certainly. First of all, it is just— why you had to tag your dog is just because you don’t want to pay a fine. Does it help you in any way?

Speaker F: No.

Speaker D: Does it help your dog? No. It actually probably more likely that your dog is going to develop a cancer in the ear, whatever the place it’s implanted, usually ear in the dogs, than anything else. And that you’ll have higher vet bills if you want to save the dog.

Speaker E: But you say, doesn’t it— does it help my dog? I mean, in the event of my dog getting lost, the police will be able to return him to me. Um, the, uh, the, the, you know, this— the same thing would, would happen if, for example, somebody had got dementia and they were wandering around? Isn’t that a good thing?

Speaker D: Well, that is how they started it, really. You know, it was approved for medical reasons, for people in enclosed circumstances like dementia patients, equally soldiers in war. But have you noticed that since implants No soldiers ever have been captured by, by enemies. Why? Because they learn very quickly that whenever they capture a soldier, they usually very quickly get bombed and killed, including soldiers and themselves. So now if they capture the soldier, they usually kill him right away rather than keeping him as collateral.

Speaker E: Basically what you’re saying is that soldiers are routinely chipped.

Speaker D: Well, those which are in combat.

Speaker F: Right.

Speaker E: Let’s see, for medical reasons, scientists are now prescribing brain implants, for example, to treat Parkinson’s disease or to enable people with artificial limbs to control them with their own thoughts. Does that raise any ethical dilemmas? One of the things that they’re talking about doing is to actually relay the responses from those implants back to a central data collection point so that they can gather a lot of information on a condition from a lot of people. Exactly.

Speaker D: How much that is helping people with dementia? Not really, because dementia is— Parkinson’s is a very progressive disease. So maybe it will help them initially for maybe a year, but afterwards it’s going to get progressively worse, or it’s going to help scientists understand it more. I think the better way of looking at it is to find why is it happening. We spend a lot of money in research and in everyday life of trying to control minutiae of human behavior, including controlling people with diseases. I think the better way is looking how we develop, including how we develop the disease, and then eliminate those circumstances so we don’t develop those diseases, rather controlling disease itself.

Speaker E: So what would you like to see happen? Would you like to see some proper ethical debate about this? Would you like to see some some sort of organization set up to monitor this and to monitor who is allowed to put what in when and under what circumstances?

Speaker D: Certainly. First of all, we haven’t had any public debate on any of those issues, and I think that’s missing. Of course, there are many entrepreneurs which are going to jump on the bandwagon and start developing all kinds of technologies because if government supports that, Of course, there will be many innovations, but we have to have some guidelines prior to it, as well as we have to set the guidelines how this technology can be used for what purposes, and should we enhance learning through technology or should we be developing people naturally rather than with technological implants?

Speaker B: Rossellini’s first company, Nexian Healthcare, runs nursing homes in Texas where elderly patients can receive implant treatment. He has some very persuasive arguments about the benefits.

Speaker C: My personal ambition is my first company was in the, was in the nursing home space here in the United States, and I saw an entire generation of Americans that were unable to complain because of lost neurological function. So nursing homes are very sad places. And I thought it was a very important place to say if we could preserve brain function, that’s the number one way to improve quality of life. And that’s been a lot of fun to have that as a mission and make progress in that regard. My first company, MicroTransponder, is a company that does neurostimulation. And we discovered a way to use the brain’s natural way of learning called targeted plasticity to be able to drive the brain to pay attention at specific points in time. And in doing that, in making the brain pay attention and then having the associated chemical soup that you need in the brain, you can make learning happen really, really fast. This has been important in patients that have tinnitus, which is chronic ringing in the ears, and patients that lose a portion of their brain in a stroke. So that company has gone off and now essentially enhanced intelligence. In our case, the reason we’re doing it is to recover from a disease indication or a loss of function. The government is now trying to enhance the ability to learn languages. So you’ll see a funded project come out in the US on that side. I find that fascinating. So the nervous system to me is an infinite amount of curiosity, wonder, and capability. The other part I’d say is where is the industry going as a whole? You have a gigantic global burden of neurological disease, and I’d say an abysmal track record for traditional pharmaceutical development to treat these disorders. The nervous system is a lot more complex than some of the other systems where we’ve seen success moments because the nervous system has a lot more complexity associated with time. So not only are you having to fix a function at a single point in time, the nervous system makes adjustments. It’s a learning system. And so I think understanding piece by piece the way that we’re doing it now, there’s going to be huge fundamental advances in how we think about neurological disease and then ultimately how we control end organ function. And the reason we’re getting that is because we all love our cell phones and TVs. And so as those electronics got smaller, it’s now a lot easier to sort of interface with the nervous system.

Speaker B: Right. So it’s the developments within the technology for mobile phones that are now aiding all of this. And so in a sense, it’s almost like the technology that’s going into satellites because this whole process of miniaturization is, you know, allowing us to put more things into space. It’s why the space race is going on. And it’s as you see what you use. So what you’re saying, if I’ve understood you correctly, is that this is allowing us to even go into our bodies? Correct, that’s exactly right. Experiments and clinical trials in the United States show that implants can make deaf people hear, blind people see, and paralyzed patients feel through prosthetic limbs. Many of these trials are led by Kip Ludwig of the Mayo Neural Engineering Laboratories.

Speaker F: When you give a drug, that drug is being delivered systemically to the whole body. You can’t titrate it like you’d like to because you’d like to give a lot of that drug only where you need it, and you’d like to give none of that drug where you don’t need it. So you’re kind of in a difficult situation. The nervous system, or the system of wires that send signals to all your end organs and all your blood vessels and things like that, to tell them how to release drugs, local biomolecules. So the, the whole goal of this bioelectronic medicines or electroceuticals efforts is to take advantage of the nervous system to teach the body to deliver its own drugs more effectively instead of taking, you know, synthetic drugs taken orally in a very non-intelligent fashion and that are very limited because, well, they just don’t have the specificity, and they’re also taken at one point during the day Whereas the other nice thing about these implantable systems is we can implant sensors to measure what the concentrations are. And then as they change due to just normal physiological changes throughout the day, we can titrate the drug every minute of every day.

Speaker E: Ages ago, Kinetic, which was then known, I think, as the Defense Evaluation Research Agency in the UK, said that they developed a system where they could put a wafer of silicon underneath the skin which had a cocktail cabinet of drugs in it and that they were going to use this for soldiers so that they could, in the event of the soldiers being exposed to chemical weapons attacks, that they could administer the antidote. What you’re talking about is something that’s gone even further than that, isn’t it?

Speaker F: Yeah, and so even those right now, in fact Medtronic has a new product for diabetes where they’re implanting really, to kind of say it in a simple way, a drug infusion pump that’s implanted that delivers insulin that also senses blood glucose and it titrates it throughout the day. The difficulty with those have always been you have to have a reservoir of the drug that has to be replenished. So the advantage of these electroceuticals is you’re not putting in this large reservoir with drug that you have to replenish. You’re just teaching the body that already manufactures this drug to deliver it where and how it needs to more efficiently.

Speaker E: I see. That turns on its head one of the common notions of medicine, which is that we think that we have to take medicines and that there’s this whole industry that needs to go and find all of these products that we need to put into our bodies. What you seem to be suggesting is that those things naturally occur within us.

Speaker F: To some extent, and often what happens when you have a disease or disorder is that what happened is the wires that tell the body how to deliver a signal to deliver the drug where and when it’s needed, that wire’s been hurt, that wire’s been damaged in some way. And what we do is we just interface with those wires, nerves, to understand what signal needs to be sent, and then we artificially inject that signal. We introduce— we electrically stimulate to introduce that signal. Again, that’s not getting where it’s supposed to be. It almost all gets down to this broken wire phenomenon where nerves send signals that teach the body how to deliver biomolecules, but the wire got broke or damaged, or it’s not doing it quite right. So these electroceuticals, often what they’re doing is recording signal before the break in the wire and then reintroducing it beyond the break in the wire. It’s almost that simple.

Speaker E: So that then means that we have to map the system to understand what is broken and repair it, surely.

Speaker F: Exactly. And so that’s part of my background. I started the SPARC program at the NIH, which was investing in tools and infrastructure and data resources, really nationally and internationally to create not just maps like the Connectome, which show where the wires connect, but the Human Connectome, if you’ve heard of it, that’s what they’re doing, but actually understand the signals those wires are sending.

Speaker E: So have we made a thorough map, or are we still in the process of generating that map of what happens and what should be there and what might not be there?

Speaker F: Well, right now there are limited versions of those maps that have been put together almost over the last 80 years, but they haven’t been connected in a way to realize this electroceutical idea. There’s so many different places where you can surgically intervene where there’s wires, but you need to understand really what you can intervene with that’s surgically accessible that can get injectable and almost in a blind fashion. I mean, ideally you don’t want it where there’s a surgeon even who has to inject it. It can almost be done, you know, as a shot by a nurse. So you need to really understand the wiring of the entire body and how these signals are being sent to look for points where essentially someone who’s fairly naive can find the wire that they’re supposed to inject these next to and have this automated system where, you know, if you don’t have to inject deep, you don’t want to inject deep. Ideally, you’re looking for nerves near the surface. That’s why you hear a lot about vagal nerve stimulation, because it’s really accessible near the— the cervical vagus is really accessible near the neck.

Speaker B: So, could an implant giving tiny electric shocks inside your body cure a cancer, for example?

Speaker F: The broken wire analogy is admittedly a simplification. There’s definitely cases where things like just pressure on the wire due to a tumor or something like that can change its function. That can be another issue. But also there can be issues where there’s even strategies right now that people are looking at to— trying to think of how to say this simply because it’s a very complex idea that I’m about to try to convey— that when you have a tumor, that tumor has to stay alive for it to metastasize, for it to be a problem. And there’s it actually needs its own innervation and vascularization. It needs its own blood vessels and it needs its nerves to teach its signals to survive. There are people looking at stimulating essentially the wires going to these tumors to make it die off in a very specific way.

Speaker E: So what you’re saying is it’s not necessarily the broken wires that the actual disease or what is wrong can actually stimulate some dangers of the broken wires that actually gives them a bit of an advantage. Advantage in terms of developing in the sense that you’re saying.

Speaker F: Yes, and sometimes there’s not a broken wire. There might be just a broken system, but by electrically stimulating the wires to that system, we can compensate for it. For instance, if you have a damaged muscle in your leg, we might not be able to activate that muscle in the way we want. We may be able to electrically activate nearby muscles to compensate for the fact that that muscle isn’t working well.

Speaker B: What’s even more exciting, an implant can train the nervous system to repair itself, or at least to create a workaround so that the body can function without the bits that are damaged or missing. At the American Defense Research Agency, DARPA, in Maryland, Dr.

Speaker E: Douglas Weber is rebuilding wounded soldiers in this way.

Speaker G: If you can recruit or train those other parts of the brain to take on those functions which have been lost, then you can recover those functions. But in order to do that, you need to essentially teach the brain to do a new trick, and that requires feedback. It needs coaching, essentially. So using these neurofeedback paradigms, we hope to identify the right sort of coaching signals to steer the brain’s learning in a direction that promotes recovery of function.

Speaker E: But this is not going— is this with implants or is this done with external sensors?

Speaker G: In most cases, it’s done with external sensors, but the same could be applied. You could implement the same sort of neurofeedback training scenario with implanted sensors., and that affords a number of advantages, but at the cost of having to have surgery done. But like I said, it may work better with an implanted device. But regardless of whether it’s an implanted device or an external device, the hope would be that after the brain relearns the task, the brain alone can perform that function. So the device becomes irrelevant once the brain has relearned or has reacquired those critical functions.

Speaker E: I mean, that’s the really interesting thing, isn’t it? Because you say relearn. One of the things that’s happening, perhaps particularly in things like reconnecting broken spinal columns or broken parts of the spine, is that the body rewires itself, doesn’t it?

Speaker G: Absolutely, and that process is referred to as plasticity, which is simply a change in the connections that are formed throughout the nervous system. Some of those changes are simple modifications to the the connections that exist between neurons. So the influence of one neuron over another is affected by what’s called the synaptic weight. And so some neurons have a stronger connection to other neurons than others. But those weights, the strength of those connections, can be increased or decreased over time. And as well, neurons can form new connections, so they can sprout new wires that then terminate on other cells in the network to change how their activity influences function throughout the nervous system. But this general concept of sort of rewiring various parts of the nervous system offers a lot of appeal from a therapeutic standpoint because for someone that has suffered an injury to a portion of the nervous system, there’s no way to rescue cells that have died. So if you suffer a stroke or a spinal cord injury and significant numbers of neurons die, they’re gone. We can’t resuscitate them. There is hope that we can someday use stem cells to replace them, right? So if you lose 10,000 pyramidal tract neurons, maybe you can inject 10,000 fresh ones and they’ll take over those functions, but that’s not yet possible. But it is possible to train the brain to take on new functions. Now, the limits or the potential of that training is not unlimited. There are certain things you can learn Certain things he can’t, you know, but that plasticity, that’s what we call restorative plasticity potential, is about the best thing we have to offer for people that have suffered a stroke or a spinal cord injury.

Speaker E: One of the things that is frequently quoted is that if somebody has lost an arm or a limb, that sometimes they complain of being able to still feel it and still feel an itch.

Speaker G: Absolutely.

Speaker E: That’s called phantom pain.

Speaker F: Exactly.

Speaker E: Now presumably that just means that all of the nerves and all of the control mechanism is there, it’s just the limb isn’t.

Speaker G: That’s right, that’s right. And because the nervous system is constantly adapting to changes in the environment, like every time you put on you maybe feel that shirt for a few seconds because it’s a new sensory input to your skin, but then within minutes you forget all about it. So your nerves are still being activated, but your brain has decided that it doesn’t need to pay attention to your shirt anymore, right? And so you’re constantly adapting to those sensory inputs, and in the same way, when you lose sensory input, your brain adapts to try to find, to try to recover that lost sensory input. And so what we think happens after someone loses a limb is the brain stops receiving input from the hand or other part that’s missing, and it tries to create a sensory experience where one doesn’t exist. And so that’s why you have this illusion of sensory input from your hand, even if you’re missing a hand. And what we’ve discovered in the haptics program, which is my prosthetics program, is that when you restore sensory inputs to someone that has lost a limb, the phantom disappears. So the phantom vanishes because the brain goes, oh my God. I can now feel my hand again. Everything’s good. And so the brain doesn’t create this illusion anymore when it has more natural sensory input to work with.

Speaker B: Fixing broken wires is only part of the story. Implants can also be used to monitor the effectiveness of the treatment and adjust the strength of the electrical current as the pain increases, for example. Dr. Richard Weiner at the Presbyterian Hospital in Dallas, Texas is involved in trials across a wide range of painful and disabling conditions. He stresses that this type of electric shock therapy is very different from what we might remember in the Jack Nicholson film One Flew Over the Cuckoo’s Nest, where mental patients received massive shocks that changed their personalities.

Speaker H: Correct, it’s much different than ECT, obviously. This is— and In addition, what we’re talking about now is not only modulating the nervous system with electrical signals, but also reading the nervous system. So it’s kind of a closed loop where you stimulate and you get a response. And reading and transmitting that response then allows you to modulate the incoming signal as well.

Speaker E: And that’s what’s really exciting. And it also means that you get some much greater understanding of the condition.

Speaker H: Absolutely. By getting the feedback, then we know— we’re continually adjusting how we treat these patients, and we learn more about the central nervous system.

Speaker E: So what are the results you’ve had so far then?

Speaker H: Well, what we’re doing— what I’ve been doing is we’re utilizing wireless devices for conditions such as what we talked about, migraine headaches. We’ve been doing been doing that for a number of years and honing in on that chronic pain conditions. We have not here, where I am, done it for Alzheimer’s, but others are. And we’re starting a study which we’re going to do a feedback study where we’re implanting in a regular Parkinson’s surgery deep brain stimulator implant.— when the contacts are in the brain, we’ll be able to then measure electrical signals from the brain, feed an impulse, and then measure the output from that directly back through the electrode and see how we modulate the signals to improve the motor problems with Parkinson’s. So we’re just embarking on a project utilizing that.

Speaker B: And Weiner believes that implants provide a better alternative than drugs for chronic pain, for instance migraine headaches, back injuries, or post-operative soreness.

Speaker H: What I’m suggesting is that there are an awful lot of patients that wind up being treated for chronic pain with opioids, and over a period of time they become very very tolerant on these opioids. And instead of going down that avenue, perhaps some of these patients at least could be treated with neurostimulation rather than opioids to reduce pain and not go down that addiction path.

Speaker E: No, I understand that completely. Having been given sleeping pills and realizing how much I started to Exactly.

Speaker G: Exactly.

Speaker H: And you don’t realize it’s insidious. And it doesn’t take that long of taking these high-powered medications, which in the beginning you’re thinking, well, I’m going to treat this pain problem, it will get better, and the patient will be fine. And that does occur after surgery, but there are some patients that continue to have chronic pain, and those patients probably shouldn’t be treated with with long-term opiates if they’re becoming addicted and tolerant. So since in the U.S. there’s been an FDA mandate to reduce opioid prescription writing, that there need to be alternatives and not just— we don’t want patients to suffer. And so one alternative in addition to non-opiate medications would be in certain cases that these electrical stimulator devices might be quite helpful as well.

Speaker E: How far, or to what extent, can the patient control the working of the implant themselves? Is this something that you want to work towards, where somebody actually says, “Look, I’m in pain. I want to just up the amount of electric shock that I’m getting”?

Speaker H: There are a number of companies out there that produce stimulators— some of them which are very programmable by the patient. So the patient can turn it on and off. They can increase or decrease the voltage setting or the current setting. And then some patients feel that the greater tingling sensation blocks the pain, and they feel that. Or if it’s too much, then they can turn it down. In the doctor’s office, the doctor usually has a computer that can actually do more things. They can change frequency, polarity, so some of the electrode contacts may be a plus or a minus, and that can spread the pain-blocking signal around. There are some new products out there that are what they call high-frequency products, and in those products, the patient doesn’t feel anything, and all they do is just turn it on and off. There’s some data that suggests that that might even be better.

Speaker E: Okay, and they’re doing that because they’ve got an implant in their body and then they have an external transmitter.

Speaker H: Is this a wireless connection? The connection for all of the systems that I just described is also internal in a generator that can be wirelessly power— not powered, but recharged. And so for the high frequency systems, The recharging occurs on a nightly or every other nightly basis, so someone could be watching a television show and sit in a chair and over half an hour be plugged in with an external charging device over the skin and recharge it for the next day or so. There are other systems that produce these tinglings or paresthesias that you can actually go a week or two. They have a lower frequency so they don’t use the battery that much, but all of them have internally implanted batteries. There are new wireless systems that are coming out where you wear an external antenna battery and it’s powered through the skin and you don’t have a battery, and that’s a true wireless system. So we’re on the cusp of some newer technology now with wireless implants.

Speaker B: With all these possibilities, will there come a day when the drug industry will cease to exist and we only need to get an implant to jolt our nervous system into producing substances that will alleviate our symptoms?

Speaker F: Kip Ludwig is cautious. In no way, shape, or form, I think, does anybody think this is going to be a cure-all for everything. But what has been amazing is So Life Science Alley has recently done an analysis where there’s over 1,000 clinical trials right now in neuromodulation for many, many, many different diseases and disorders. And what we’re finding is in patients that are just absolute train wrecks, completely unresponsive to drugs, we’re seeing in many cases, say 15 to 20% of these patients, completely cured or at least very— not cured, but cure is probably the wrong word, have all of their symptoms go away because they still have the underlying problem and they need this device. And then another 20% of the patients were seeing, you know, very good results. And then 40 to 60% were seeing these very mixed results. What’s amazing though is this is human data in patients that had no other alternative, and we know so little about these functional maps, yet we’re still seeing these large effects in cases where drugs didn’t work. Or had stopped working because people just adapted to them over time. So I’d say that’s the promise. Is it going to cure 100% of the patients? No. Is it going to cure diseases? These aren’t even cures per se. These are things that teach the body to better deal with symptoms. But in some of these cases, where you talk about people who had intractable seizures suddenly being seizure-free or going from a frequency of 30 seizures a month to 1, That’s some of the results that we’ve seen and have been proven in double-blinded, sham-controlled clinical trials. There’s the highest standard of clinical evidence we have. So it’s amazing that we’re getting these effects in the highest standard of clinical evidence that we have when we still understand so little about these functional maps. So that seems very promising to invest into, to understand more, because unlike the drug world where they’re having this huge problem with Lots of animal studies not translating to human beings.

Speaker E: We have these remarkable human effects, yet we don’t know how it works, so we can’t optimize.

Speaker B: Still, there are long-term conditions where brain implants are already bringing benefit, according to Professor Ashwini Charan, the neurosurgery program director at Philadelphia’s Thomas Jefferson University.

Speaker I: So today there are 2 or different, 2 or 3 different implants that are approved. And basically all these implants are what they’re trying to do is hit different nodes on the brain circuit to try to prevent the seizures from spreading. You know, when we do the surgery for epilepsy and you know, we’re putting implants in the brain for Parkinson’s, for depression and a few other disorders. When we do it for that, this is very elective brain surgery and today’s MRI technology you know, surgical tools, robotics, those things have made bleeding rate inside the brain 1% or less.

Speaker E: Okay, Ashok, so what is going on here then?

Speaker I: What is it that these implants are doing? So this is an electrical activity. The simplest way to understand it is it’s like a short circuit. So if there are a set of neurons, a set of nodes inside this complex brain structure that are dysfunctional,, then you have a lot of noise being injected into the circuit. And so the implant is usually put in a spot distal to the noise to reorder that circuit.

Speaker F: See, the brain does better with an ordered signal than it does with a disordered signal.

Speaker E: Well, what are the results you’re getting from treating epilepsy and the associated conditions?

Speaker I: Yeah, so, you know, with epilepsy right now, I think we’re still young. So in epilepsy, we’re getting 60% to 80% reduction in the number of seizures. In less than 10% of the patients are we actually putting enough signal into the system that the patient is cured. You know, it’s very different from a disease like Parkinson’s. And I’ll explain the difference so that people understand. The first time we started putting electrical signals in the brain and predictably having great results was Parkinson’s disease. When you do that for Parkinson’s disease, it’s dramatic. I bet you 80% of the people routinely have reduction in tremor, rigidity, or medication dosage. And the results were always great in Parkinson’s because Parkinson’s, when the brain is going bad, there’s only one or two particular nodes that are going bad. In epilepsy, the disease becomes much more complicated. And there are probably multiple nodes that are affected. And so my sort of guess or hypothesis is that we’ll get better at treating epilepsy when we get to a point where we’re aiming at multiple nodes. Because right now when we’re putting wires either on the vagus nerve, in the brain, in the thalamus, different targets, we’re only doing one target at a time. So I think it’s a more complicated problem.. And so it’s sort of a stepwise approach, right? We needed to prove that we can safely hit one or two targets, and then of course they’ll get more and more complicated as time will go by, as this will evolve.

Speaker E: Okay, all of this sounds wonderful. It sounds like amazing new developments in science and technology, but could anything go wrong?

Speaker I: I mean, could, could an implant malfunction, for example? You know, the implants, interestingly enough, the manufacturing technology is it’s probably on the 7th or 8th generation. So it is very rare that these implants spontaneously fail. The failure rates must be less than 1 in 1,000 or 1 in 10,000. So the more common things that go wrong are human factors.

Speaker E: Okay, I mean, there’s been a huge amount of concern in the US and in the UK at the moment about medical devices and the computer security on them, the cybersecurity. There was even talk that somebody had hacked a pacemaker.

Speaker I: Can these implants be hacked? I think the answer is yes, they can be. The only saving grace right now is the radio receiver is typically good for 7 inches, so it would have to be a very nearby hacker. But I do know that the world of cybersecurity is evolving greatly and regulatory hurdles that our governing bodies put on the device manufacturers, I bet you are prohibitive to them upgrading their security systems because that would require reapproval.

Speaker E: What are the implications for a patient of having a gadget that steers and modifies behavior and sensations? Could it affect your sense of identity or your sense of being in control?

Speaker I: I don’t think in this, I don’t think in this generation of device. You know, we are using quite early tools. You know, for epilepsy or for Parkinson’s disease, the probability of affecting personality is very low. The personality is actually determined from the frontal lobes, and most of the time these devices are being implanted deep in the brain, or actually in a part of the brain called the temporal lobe, and they’re really not personality centers or identity centers.

Speaker E: When you say it’s a memory control system, Surely people are going to be worried about that.

Speaker I: I mean, memories could be wiped, could they not? Oh yeah, so this is actually something that we do take quite seriously. I suppose if somebody were able to overstimulate the brain in a manner, it could— I don’t know, it wouldn’t wipe long-term memories, but it could affect the formation of new memories, which could be a problem.

Speaker B: Oh yes, erasing memories could be a problem, but it could also be a blessing if the memories were painful and psychologically disabling. Many people who’ve lived through war and terror suffer from post-traumatic shock disorder. I’m one of them, ever since I was a correspondent in the first Gulf War. Victims of torture and survivors of childhood sexual abuse could, in theory, also benefit from losing bits of their memory. Rewiring memories in real life is still some way off, and we probably need to have an ethical debate before we give that power to the doctors. So internally things could go wrong, and there are external threats that should not be underestimated either. It’s just been announced by the US Federal Drugs Administration that pacemakers made by the American medical device manufacturer St. Jude Medical could be turned off by hackers, a week after the company was sold for £18.8 billion. The FDA highlighted the risk because medical devices have become increasingly interconnected with the web and smartphones. According to researchers working for the medical regulator, the pacemakers could be made to give unwanted shocks and the batteries could be run down. Hacking expert Neil Barrett, a former professor of cybersecurity at the Royal College of Defence Studies, warns that the tiny implants are vulnerable to different types of attack, such as a DDoS, an overwhelming barrage of information, or ransomware, where a virus locks up the information on a computing device.

Speaker A: The smaller the system, the smaller the amount of processing in total that you can get into it. So you’re going to prioritize the space in the chip for task-related activity. I’d be prepared to bet that security-related activity would get deprioritized in it. So for instance, you might not have proper array bound checking, meaning that you can overflow a buffer and either crash it because it’s gone writing into memory that it’s not supposed to write to, or do the classic old buffer overload which loads a process which takes control.

Speaker E: No, absolutely. So what you’re saying is that by making the computer do too much or more than it is expected to, or making the little chip do more than it is meant to, that you can force it into perhaps rebooting itself and rebooting from a place it’s not meant to.

Speaker A: That then means that you can either take it over or you can swamp it.

Speaker G: Yeah.

Speaker A: Crash it or control it. Crashing it is the easiest one to do because it doesn’t matter then what it is that you’re writing off the end of the buffer or what you’re writing into a a particular part of the processor. It’ll just crash at whatever point in time you want to do it. If you can write something in there that takes over control of it, which is going to be quite difficult to do, you’d need quite clever access to the processor, quite clever access to the code that’s running in the processor. But if you can do that, then yes, you’d be able to control it.

Speaker E: Do you think that that means then that there is some need before people embark on further development of this technology to sort the security issue out. It was said in a study that was done recently that there is more cybersecurity on gaming consoles than there are on medical devices.

Speaker A: Oh yeah, easily. I mean, the honest answer is there’s more security placed around payment mechanisms of any sort than there is around medical or control systems or embedded control systems like— I mean, we’ve talked before about embedded control systems in cars, for example. I mean, it all comes down to how much of the— what percentage of the space in the chip. If you think of the chip’s memory and processor collection, processes collection as being the volume that’s been occupied. How much of that volume are you prepared to dedicate to security and gatekeeper checking and array-bound checking and true logically controlled systems? How much of that are you prepared to dedicate to it versus dedicate to the task that you actually thought it was going to do in the first place?

Speaker E: This is going to be the conundrum, isn’t it? Because the essential conundrum is— that they’re already achieving incredibly good results with this. So you can actually affect somebody’s quality of life. They could have a very poor quality of life. And so what you’re doing with these devices is saying, I’m going to install this. You’ll get a better quality of life.

Speaker A: And let’s hope that somebody else doesn’t interfere with this. Yeah. I mean, any of these embedded control systems, you’ve got to try and think around not just what it is you’re going to do with it, but what happens when somebody decides to make it go wrong.

Speaker E: Well, this is another issue, isn’t it? Because if you think about it, the fastest growing crime trend at the moment is ransomware. Now, it’s fairly inevitable that criminals will sit there and think, hang on a minute, what if I lock up somebody’s chip inside them?

Speaker A: Well, no, no, it’s not even that. What if I threatened that I’m going to do this? And who am I going to threaten? I’m going to threaten the companies that are making it. At a random point in time, a random victim will get a randomly nasty thing happen to this system you put inside them.

Speaker E: Are you going to pay me money not to do it? But there’s surely a far more chilling scenario, is approaching some elderly or vulnerable person and saying, I have put something on your system, pay me a ransom, otherwise I will turn off your heart pacemaker.

Speaker A: ‘or I will turn off your brain pacemaker.’ You would go to the company because, first of all, the company’s got more money than an individual. Secondly, by approaching the company, you can by proxy threaten as many victims as the company has got— customers or clients or patients. You don’t have to go around person by person, patient by patient saying give me money or I’ll turn you off. You can go to the company and say give me lots of money or I will randomly turn off random victims at random points in time. So therefore what you’re saying is it’s obviously in the company, and the point is that that runs the risk of taking down the company’s reputation, the trust that the company requires, the position that the company holds in the medical field, you’re threatening much more than just one poor person with an anti-epileptic implant.

Speaker B: Those risks are apparent too, even to implant evangelists like Will Rossellini.

Speaker C: Well, I’d say we have to be very careful because the idea that you could potentially hack somebody’s device— as we get more and more capabilities in the nervous system, we’re going to have to be very focused on cybersecurity for systems like this. With this technology that could do so much good for so many people, there is an added responsibility of saying, what are the ethics associated with how the data is controlled and how is it protected?

Speaker B: But see, and this is fascinating because I, I wrote a report that we sent to the European— I was presented to the European Union and led to me being asked to give a speech to the French Senate. And, and I was saying Surely we’re going to have to reach a point where we say that hacking particular devices, hacking particular servers, you know, that is just a totally no-go area for anybody. It’s got to be utterly sacrosanct and it’s got to be a human right, which I know sounds like a bit of a pompous way of saying it, but with the potential, you do have to underline that there are lines that you cannot cross with all of this technology?

Speaker C: Yeah, we did, uh, um, we did an ethics of the, uh, augmentation. So we did an ethics on, um, not only protecting the data rights that currently exist for diseased patients, but ultimately right now there’s people experimenting with, uh, uh, neurostimulation on themselves to enhance their capabilities. And so what are the ethics associated with augmentation? And you get into there’s some interesting ethical situations. You know, for example, some deaf parents don’t want their kids to get cochlear implants because the deaf community wants to maintain a culture of sign language and communication. And the implant, the cochlear implant, makes it to where the child doesn’t need to learn sign language. So from an ethical perspective, there’s a choice there, who’s in charge of taking that implant versus not. And then ultimately, is it, you know, is the state responsible for providing education to those children that are not getting the implants and that cost more money to the state? So we dealt with a lot of those ethical challenges associated with augmentation. It was actually a CNN-hosted thing. So that does exist. There’s a draft of how we would make decisions. But I think these decisions are only going to get more and more difficult as we think about what it means to be a human being and how we can upgrade ourselves.

Speaker B: This is already coming, this, this debate, because, you know, there you are, you’re a very, very wealthy person, you want to make sure that your children are incredibly intelligent and that they stay in exactly the same position as you are, because traditionally that’s one of the things that humanity has always wanted to do. It’s wanted to maintain status for itself and its successors. So what would you do? You— if, if you can use this technology to put your child into an accentuated mode of learning, then you will do that, surely, right?

Speaker C: But then that would give them an advantage over somebody who was poor, which was totally unfair, right? It’s only going to exacerbate the divide between rich and poor, that’s for sure.

Speaker B: And then I think that that’s right And the question is, what do you do about that? Some people, like Chris Sobrist, are already taking advantage of do-it-yourself shock therapy using YouTube videos and simple strap-on electrodes.

Speaker J: Oh yeah, absolutely. When I was first using the Focus and I was trying— I just tried the continuous waveform for the first couple weeks just because that followed the protocols that were found in the published studies. I was curious about the other one, so I just tried it more just out of curiosity.. And when you set it to either pulse or the sine wave, which actually delivers pulses in between waves, I noticed phosphines, what are called phosphines, which is actually the current stimulating the optic nerve enough to create a flash of light in your visual field. And so that was my first kind of experience with actually seeing the effects of the stimulation. It was kind of scary at first, but I learned later that it was not dangerous. I actually started to notice improvements in my vision. And I have a congenital condition called optic atrophy. And so I’ve been actually legally blind since birth. And so it’s always been hard for me to see things from far away. And when I started using tDCS, I actually noticed that I could see things, notice things in my visual field farther away than I could before, especially at night. That’s what kind of led me to start using it every day is if it was improving my vision, I thought, okay, well, I’ll do it more and see how far I can go. So I had been using it every day for 6 months and kind of also measuring my vision with various tools, apps, and just seeing things from distance. After about 6 months, I think I kind of topped out in terms of what I could gain from improvements, and so I started tapering down my usage. And so now I’m down to about once a week I use it, and I don’t feel like I need to use it, but it’s just something that helps It helps me to either concentrate better. Sometimes I’ll use it before going to a workout where I want to get a bit more strength training or endurance training. And sometimes I use it to help go to sleep, actually. There’s protocols that will help to aid in sleep or pain reduction. So, those are my things that I kind of use it for and usually just once a week. I started shaving my head actually before I started using tDCS, but then after starting to use it, became very evident that it was a benefit to not have the hassle of hair. My girlfriend also uses my tDCS device, and I started working with her to use it for her motion sickness. She gets really carsick, and so it was a problem for us, especially when going on long trips. She’d have to take, you know, medication to basically knock herself out. When you’re on vacation, it’s not a great thing. So she’s been using it to, you know, before we go on a car trip, and it’s amazing because, you know, before she started using it to today, she’s perfectly comfortable in the car. She can text and do all kinds of stuff, whereas before she would just be totally out of commission. But the hair thing is definitely— makes it more challenging for her to use it than for me.

Speaker B: Such self-help systems are worrying the experts because the possible side effects are unknown.

Speaker F: Here’s Kip Ludwig again. Right now, the risks so far outweigh the knowledge, although there are people doing it in very unsophisticated ways. There are non-invasive stimulators that you can even go— there are YouTube videos on how to do it, and people are sticking electrodes in their heads for— on their head for, you know, advanced— getting better at video games, for instance. That’s scary stuff. And honestly, the science does not warrant it right now, but that’s why we have to develop a science, because right now a kid can go online, go to YouTube, and figure out how to strap an electrode to their head, and there’s this— the YouTube video says this will make you better at your favorite video game. So we absolutely have to invest in this because it’s almost so easy to do noninvasively that we have to educate and better understand how it works ‘Cause otherwise, non-scientists are gonna be doing it to themselves anyway.

Speaker E: So there is a need for some ethics, but there’s also a need for some education. What you’re saying is there’s more of a need for education because you need to be able to say, “People, don’t do this.” Yeah, well, I’d say both.

Speaker F: I think people need to understand where the science is at, what’s provable, and what the risks are with any of these things, especially when it gets to anything to do with augmentation. But also, All of the major efforts through the BRAIN Initiative, through the SPARC Initiative, and even through the companies that are doing this all have ethics components, and we’re all talking to ethicists to better understand. I mean, realistically, for the non-invasive stimulation, most of our biggest concern is it’s already out there and not being regulated.

Speaker B: How do we prevent this when it’s so easy to do? Improving your gaming skills is one thing. Far more worrying is what I’ve been hearing in military circles about the potential for these technologies to produce soldiers with superpowers. Are they building a cyborg army, with the Americans and the Chinese in an arms race to capture the best augmentation techniques?

Speaker H: What does the future hold? Richard Weiner only sees positive development. We’re talking about urinary incontinence. We’re doing some work now placing electrodes over for just a nerve in the leg that controls incontinence, for male and female sexual dysfunction.

Speaker B: So it’s a brand new day out there with electrical stimulation. With $110 million a year of research funding for the Obama Brain Initiative that is behind the implant technology, Douglas Weber too is optimistic. But he admits that as an engineer, He does not have all the answers, and technology must not go too fast for society.

Speaker G: DARPA, and I’m sure NIH and all of the funding agencies, have ethics panels that weigh in on some of these issues. You know, so at DARPA we have what we call the ELSI panel, which is the ethical, legal, and societal implications of our research.

Speaker B: It’s a technology that has also been developed by scientists in Europe at the Human Brain Project. But ethicists are quite a long way behind. For example, the British Medical Association published a paper 10 years ago calling for questions of rights and responsibilities to be established over brain implants and augmented brain power. But their rhetorical questions have remained at the rhetorical stage. From my perspective, the scariest aspect The risk of all of this is that governments, or worse, unelected bureaucracies, could use implants to track not just our whereabouts, but all our most intimate medical records. Vast connected databases will be created with obvious risks to patient confidentiality, privacy, and identity. The promise of implant technology is huge. It will be able to deliver vast pools of data that will provide detailed and accurate information on exactly what happens in our bodies so that we can begin to understand diseases in a way that our forebears only dreamed about, spawning new cures, remedies, and devices that can deliver personalized healthcare in a targeted, sophisticated way and help our aging population to hang on to its marbles and all of us to live longer and healthier lives. But. It could also permanently divide our society, making us technological haves and have-nots, with those at the bottom doomed to forever stay there as an enhanced, super-educated elite leaves them behind forever.

Speaker A: The test of bio-electronic technology, as with all medicine, will be to deliver a cure with no unpleasant side effects. This program has been brought to you by Resonance 104.4 FM. If you liked what you heard and want to support our work, please make a donation at fundraiser.resonance.fm.

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