[music]
I see you're sipping your decaf coffee now. I just learned that apparently the company that you're sipping from that we've been talking about can be a little litigious. So I don't think we no longer will be giving the name of the company until they start paying us for the advertisement.
Well, that sounds fair, but I mean, we deserve a break today, you know, as they say.
So your nondescript decaf coffee that gets you amped up.
That's right. Exactly. I'm very disappointed that a sponsorship deal has not gone through with this company that will remain unnamed. I don't know what we can do to help this deal cross over the line here. Maybe do we need to contact Ronald Donald directly or maybe one of his underlings like Grimace or The Hamburglar?
You're being very subtle with regards to the coffee that we're drinking.
Exactly. But really, I mean, if you think about it, they'd be a perfect sponsor. They'd be a perfect sponsor. I mean, they have a lot of money, and maybe they could give some of that to us.
I think that sounds nice.
That sounds nice, yes.
Dr. Abbott, we're talking about decaf coffee. It would be remiss to not mention that there's also someone else in the room right now.
There is, yes, yes. Very thrilled about this other person we have in the room here because today is actually the first time we've had a guest on our show. Yeah. And we got a good one too. It's like, whoa, we moved up in the world here.
I'm super excited. So today we have Dr. Colleen Hanlon. I can give a little bit of a bio. Dr. Hanlon's a neuroscientist and one of the leading voices in non-invasive brain stimulation. Tons of experience in TMS, brain imaging, addiction neuroscience. She serves as the vice president of medical affairs at Brainsway. Before Brainsway, she led clinical research programs at MUSC and Wake Forest with a major focus on mapping brain circuits, involving craving, Q reactivity, substance use disorders, depression, and recovery.
I'm super excited about our conversation today. I am hesitant to believe in substance use with regards to how TMS can impact it. So I'm excited to learn because I haven't – I don't know if Dr. Hanlon knows. I'm a naysayer. I say no to – I disappoint everyone. So I feel very bad for Dr. Harvey. I don't know. He's used to me going – but I'm excited to learn.
I'm open to learning new things.
Yeah. Yeah. Yeah. Yeah. And I was, uh, yeah. And I, I think Dr. Hanlon has what, like, like, uh, 40 or 50 publications just in the last four years or so. It's like, what the heck? It's like, do you ever like sleep or anything like that? Or why do you do all that? Jeez. But that's, it's impressive. It's a lot of stuff. Oh yeah. But that's, yeah, but that's, that's, that's all very exciting.
So, uh, So yeah, so if we could, Dr. Hanlon, hi. Hey, can you say hi? And did we miss anything as far as introductions for you? And can you tell us more about Brainsway? Whatever you want to start with, tell us more.
Hi, guys. Dr. Harvey, Dr. Malzberg, thank you so much for having me as your first guest. I feel so honored.
You're special.
And I'm also like up for the challenge that I hear that Dr. Malzberg is a naysayer to just say no message of the 80s very literally. You can change the line.
I am very open to changing my mind. I was a hater for TMS too until I saw so much data that I had to be swayed or else I'd be obnoxious. So I'm open-minded, but my stance on everything is to start as a hater. But I'm open-minded to having my mind changed.
That's okay. You're like a true scientist. That's how we all first start, right? Yeah, yeah, yeah.
One thing I'm wondering, how did you get hooked up with Brainsway? How did you move from having your own lab to being vice president of Brainsway? How'd that happen?
Yeah, thanks. So, right, as you mentioned, so I started my career. I actually was, you know, pre-med since I was like five years old. Then I got to college and took all the courses. And I really only did research in college because I thought it would help me get to med school. And at the time, I, you know, I did that and I was putting electrodes on the arms of patients that had a stroke.
So actually, like, you know, it's peripheral simulation in this case to help change the brain and improve recovery of function and stroke. And it was really great. It got me hooked. So I decided to go to PhD school. And there I started using functional MRI to look at the brains of patients that had a stroke. And at the time, functional MRI was the new thing that Now, when I look back at the papers that we all wrote at that time, we would never use those methods anymore.
But, you know, you have to start somewhere, right? I think TMS started in that way as well, right? Like, you have to start somewhere. And then as the field matures, we get more and more evidence. And ultimately, we can convince people like Dr. Malzberg that there's enough evidence to come off the fence and to try it, right? So... In this journey, I did a lot of brain imaging.
When we started, I moved to studying addiction through dopamine. So dopamine is actually also responsible for recovery of function after stroke,
interestingly.
And the people that knew the most about dopamine at the time was the addiction crowd. And if you know me, I was a pretty good kid. Didn't drink alcohol till I was 21. Never a cool kid. Didn't smoke anything. And so when I started working in the addiction space, in my head, I was probably fairly judgmental about the people I was working with. But, you know, I was in my 20s.
But like, that's what happens as you get older. I remember sitting with a few people listening to their stories. And these people were dependent on alcohol or dependent on cocaine. And I remember learning like, you know, these people actually kind of grew up a lot like me and they seem like really personable. Maybe we're all just sort of one traumatic event away from our life going in a very different direction.
So in doing research, humanized me. Like I actually, I feel like I became a much deeper person. That's how I got interested in addiction. And right around that time, TMS was FDA cleared for depression. So all of a sudden, we had this way to non-invasively change brain circuits. And actually, at that time, we understood the brain circuits of addiction a lot better than we understood the brain circuits of depression.
So I was at Wake Forest at the time as a postdoc. And I was sitting there with my clinical patients and my best friends across the hall were shining different frequencies of light into the brains of rodents. And so this technique basically allows us to manipulate activity in the brain through sort of fiber optics essentially. And so this optogenetic manipulation of the brains in rodents can actually make them press a lever more or less for cocaine.
I'm going to get this wrong, but it's something like you shine blue light and they press the lever more for cocaine and you shine yellow light and they press the lever less. But that required electrodes be implanted deep in the rodent's brain. So what if We could use something non-invasive to change these same circuits. So instead of shining a high frequency light, we actually stimulate at a high frequency the same areas of the brain in people with addiction.
So that's kind of the science basis. So I moved to South Carolina to work with Mark George. And Dr. George was willing to try all kinds of things. And I remember going to his lab and saying, Dr. George, I really want to use TMS in patients with cocaine use disorder. And he said, well, that sounds great, except that it's probably the number one reason we don't do TMS.
Dr. Malzberg, for example, probably would never do TMS in somebody with cocaine use disorder because it's like written right there clearly that you shouldn't.
Yeah, thou shalt not. It's
on the
helmet.
Yeah. If you follow the rules, you might not want to do that. But as researchers, we want to break the rules, right? Because we want to see if we can expand our capabilities. And so it was a really fun time in Charleston, South Carolina at that moment. There were a lot of great people there together. And like a bunch of sort of cowboys, we tried new things.
And one of the things we tried was TMS for addiction. And we did cocaine use disorder and methamphetamine use disorder, a lot of alcohol use disorder. Yeah. Fast forward 10 years, built a lab, professor, blah, blah, blah, students, good times. And I've believed so much. There are so many labs doing TMS in the addiction space, getting with different types of coils, getting very comparable results. And I was like, we need to bring this outside of the ivory tower and out into the world.
And to do that, academics don't go to the FDA. Companies go to the FDA. And so the biggest company in this TMS space right now that goes to the FDA more and more and more is BrainSway, undeniably. And our good friend, Dr. Bumi Zangan kind of helped lead a lot of those efforts. They'd just gotten FDA clearance for smoking, and so A led to B, and here I am leading their research.
Ah, okay, okay, wow. So you really focused on neuromodulation for substance use disorder pretty much the whole time. So that's interesting. Yeah, and I didn't realize that you had done some of the preclinical work with rodents. That's very cool. Just the thought of a rodent pushing a lever for cocaine brings up all kinds of thoughts. Yeah. But wow. And then I guess I'm also curious about the research that's currently going on at Brainsway, the top secret kind of research.
Are you allowed to tell us about that?
Well, I guess I may have to kill you, but if you'd really like to know. Yeah, so we are continuing our sort of dedication to addiction. We're running a trial right now, a multi-site trial of deep TMS for alcohol use disorder. And we just launched our ninth site two weeks ago. Oh, wow. So we're hoping good things for that. Oh, go ahead.
Oh, yeah. So what can you tell me, are you allowed to tell me the brain stimulation protocol you're using? What part of the brain are you targeting? What kind of stimulation?
What are you
measuring? How are you?
Sure.
Everything. Everything. Yeah. How's this going? Yeah.
Yeah, of course. The goal of the trial is to reduce heavy drinking days. So a nice thing about with alcohol compared to some other substances is the FDA is okay with a harm reduction strategy. You don't have to be completely abstinent because data has shown that just reducing your alcohol consumption, having no heavy drinking days has really important effects on liver function, on blood pressure, Ultimately, stroke rate, cardiovascular.
So there's a huge effect beyond just your brain and your mental health, also on your biologic health. So the goal is to reduce heavy drinking days for six months. We have an interim, so the study is a six-month long study. The first primary endpoint is at four months. People will be receiving two sessions of DTMS per day. Plus some psychotherapy in the middle of those two sessions.
And the TMS, excitingly, is going to be delivered with new technology called Rotational Field Deep TMS.
Oh, yeah. So, yeah, we're excited about that. Yeah, and I'm super excited about Rotational Field TMS also. So, let's, you know, let's... Let's go on that side quest because I know some about this.
Yeah, let's pretend I don't know about it and teach me about rotational.
Yeah, Dr. Maltzberg does not yet know about rotational. Oh, your life will never be the same after you hear about rotational TMS. So be prepared for the world to never be the same.
Yeah.
So please, obviously, Dr. Hanlon, they're far more than I do. So yeah, no pressure. Yeah. So tell the audience about rotational TMS.
Yeah. So as we all learned when we were first learning how to do TMS, that the TMS field, so in the most like first generation coil, like a figure of eight coil, placed upon the motor cortex, let's say, the direction that the And that's because of how the coil is aligned with the head is very important. And if you rotate the coil a little bit, you're going to lose activity in the hand.
So when you're learning, typically in CME courses for TMS, you're taught to place a figure of eight coil at a 45 degree angle. The rotation or the orientation of the coil is really important. If you rotate it off of that angle, you get a different population of neurons. And so we teach the 45 degree angle because that's the highest population of neurons you're going to get.
Because that's kind of where the neurons are lined up in the cortex. Yeah.
That's right. And the motor cortex is very organized, just like lots of nice, beautifully straight gyri. But think about when you move to the prefrontal cortex, the gyri are all jumbled up.
Angled mess. Yeah, it's all crazy.
Angled mess. That's right. In fact, as a fun fact, the folding of the gyri on your brain is more unique than your fingerprint.
Really?
Yes. Fun fact for the podcast.
That is fun. That is fun.
So you imagine now you have this coil and you move it to the front of the brain. Where you have lots of folds and stuff, and now you're getting a different population of neurons, right? But because the brain is all folded, we don't actually really know the optimal angle, to be quite honest, that a figure of eight coils should be placed on the prefrontal cortex. And so a better strategy would be to create a type of TMS coil that could not only Get the primary plane, let's say 45 degree angle, but it could also catch the neurons that are slightly different plane and catch the neurons basically oriented in 360 degrees.
Because then the angle wouldn't matter. And for every pulse of TMS, instead of capturing approximately 10% of neurons, which is what we do now, you would capture closer to 100% of the neurons that are affected by the electric field.
Which is awesome stuff. So if I understand this right, that means I guess right now every pulse is like a pulse in one line, you know, like it points one direction. But with rotational TMS, each pulse is like a helicopter blade that rotates once. It's like boom, boom, boom, but it's like a rotational boom. So it gets all the, yeah, yeah.
That's exactly right.
Yeah. And I noticed, you know, if it gets, you know, 90 or 100% of the neurons instead of 10%, one thing I noticed is that 100 is more than 10. You know, is it going to be like, is it, you know, I mean, so if it's 10%, if that's 50% effective, is this going to be like 500% effective? How does the math going to work on that?
That's right. As far as effectiveness.
MDs, we're not good at math. That's the PhDs.
Map petitions.
Maybe you get Lucid or Mail and people write in and they say, no, no, no, Dr. Hanlon is wrong. It's actually 15% of them are wrong. I will take that. It's probably somewhere in there. But no matter what, if you have the helicopter blade, it's going to be more than if you just have the line, whatever the numbers might be. And we see that. It plays out in the data.
So the way that translates in the real world is that motor thresholds are much lower. So... It doesn't take as much energy to make the hand move because you're depolarizing a larger number of neurons. So that data has been published. So the motor thresholds are lower. In fact, right now in our trial, we're seeing the average motor thresholds thus far Usually in the, in these are like in the thirties.
Oh, wow.
Whereas when I was going to drink oil, they tend to be in the forties and fifties maybe.
Yeah. Oh, very nice.
Another important thing that we think is important about the rotational field is, um, it's going to be useful for people that have a lot of brain atrophy. So we think about alcohol for one causes a lot of brain atrophy, right? You see this sort of shrinking of the brain over time. But we think about diseases like Parkinson's or dementia or any diseases of older adults. What's happening there, right, is the brain is coming further away from the scalp.
And so in order to depolarize enough neurons, basically there's not as many neurons around to depolarize. So a really nice thing about rotational field is that helicopter blade analogy you shared, right? You're going to sweep up as much as you possibly can. And so a patient who, if you were to give a standard single line to, might not have enough neurons in there to depolarize their brain.
If you give this sort of helicopter blade, you're going to sweep up enough neurons that there'll be spatial and temporal summations. Nice, nice.
So I'm wondering how come this rotational TMS thing is being trialed for substance use disorder instead of just major depressive disorder or something like that, you know, something that TMS is already used for. What was behind the decision to use it for that treatment?
Yeah, it's a great question. We have done a study. There was a study published a few years ago on rotational field versus standard H1 TMS for depression.
It was small though, wasn't it? Wasn't it very small? Very small. That's right. I saw it. I saw it.
Yeah. And there were aspects about it that are a little bit unusual, but it did show a higher effect size for rotational than standard. I think one of the things we think is really special about rotational though is the ability to To work well on patients with brain atrophy. And so because you're getting more neurons, more bang for your buck essentially. And so that's why we decided to sort of move in the direction of patients that have some type of atrophy.
And since we're already in the psychiatry space, you know, alcohol use disorder kind of fits into that well. And plus we have great pilot data for similar patients. Similar studies essentially in alcohol use disorder.
Interesting, interesting. That's super cool.
Yeah.
You mentioned- Oh, go ahead, Dr. Milsford. Oh, okay. I'll go first, then you. Okay, yeah. So just also so people can picture how this rotational TMS thing works, I'll kind of give my explanation of how I think it works, then Dr. Hanlon. Then Dr. Hanlon can follow up and correct anything I said that's wrong, which might be everything I say. But my understanding of how this works is, first of all, it's not...
It's not a rotating coil. It's not like the coil is spinning around like a helicopter. It's not doing that. But what it is doing is it's two figure eight coils that are situated orthogonally to each other. They're situated at 90 degrees to each other. So that one coil creates one vector, the other coil creates another vector at a right angle to the first vector. So you have those two vectors at 90 degrees to each other, and you can summate those vectors in a way that you can point any direction in a 360 degree sweep.
So you organize it so that the electric field is actually doing that 360 degree sweep. Did I get that right?
And it's very close. Very close. But good job. It's definitely, it's close enough to get a V+. The only exception is it's not two figure of eight coils. Oh, okay. So the geometry on the bottom is more like the H7 coil that we have. And then, so it's this kind of like flexible structure. And the geometry on the top is almost like a ring-like structure.
Oh, really? Yeah. Oh, do you have one of those nearby for show and tell? I know this is most of you.
Oh, you don't. Okay.
Okay. But very close. Yeah. So you have, but it's, you sell the same premise that you have two coils that basically we can allow the current to flow through these coils in a certain pattern such that by changing the The orientation of two pulses that are coming through the coils, you can have a vector that goes 360 degrees.
Yeah, that spins around with each pulse. Nice. That's right. Dr. Maltzberg, is your mind blown?
My mind is blown. My mind is blown and this is above my head. This is all very, very cool. Now, I'm going to bring us back to... Um, things that my little, my little atrophied brain can understand. Can you talk a little bit about the results? Um, so far you've been talking about the cocaine use disorder, the alcohol use disorder, focusing on, uh, decreasing use. Um, I know Brainsway has an indication for, uh, for, for nicotine use for smoking.
I want to hear about the numbers on the results for all these different things.
Sure. I guess I would say right now for the alcohol use disorder trial for the multi-site study, we don't know the results yet. So we're still in process. But the pilot study leading to it, I had about 50 patients that were enrolled and they received either active or sham TMS. And they received TMS about five days a week for, I think it was four weeks. And they monitored people for three months after.
And the group that received active deep TMS, this is with the H7 coil, was sober, significantly longer than the group that received sham TMS. So that kind of was the pilot data that led to the multi-site study. For the smoking study, so right, we have FDA clearance for that. I guess if I was really as smart as I could be, I'd have those numbers memorized, but I don't.
But I can tell you that ACTIV was better than SHAM. So this was a multi-site pivotal trial. And that the effect size for deep TMS for smoking, which is with the H4 coil, is comparable to varenically. Oh, wow. So for a medication. So that's kind of something to consider. Mm-hmm. But I would say if I can steer the conversation a little in terms of results, what I can tell you is that we just finished, we did a, you know, there's a lot of enthusiasm right now.
You guys know and your listeners know about accelerating TMS for depression treatment, right? And there's different flavors of it. More and more FDA clearances are out there, which is wonderful for everyone. And we got FDA clearance for a protocol. Last year, which we're calling the SWIFT protocol. And that's five sessions of deep TMS per day for six days. So it's about a half day. And the six days can occur any time in a two-week period.
So there's a lot of flexibility built into the protocol. And we had great remission and response rates. And we just finished a one-year durability study. Wow.
Oh, yeah. I think I saw that. That was published, too, wasn't it? The durability.
We just presented at the Clinical TMS Society a few weeks ago.
That's where I saw it. Okay. That's where I saw it.
Yeah. And I think everyone would have guessed that the durability, in fact, myself, that the durability of the accelerated would be less than the durability of standard of care. That's how the FDA pivotal trial was structured in that way. 104 people were randomized to receive the accelerated deep TMS versus standard once a day. And at six weeks, the response and remission rates in both groups were above 75%.
And then we followed them for a year. And I think a lot of people, including myself, would have hypothesized that the effects of accelerated would wear off a little bit faster. There's a sense that if you learn it If you cram for the, you know, we've heard people say if you cram for the test, you don't remember it as long. But in fact, actually the durability was comparable in both groups for a full year with the response and remission rates also being above 70% in both groups at a year.
So we're excited about those data, writing the manuscript now. So yeah, I think that's like from a data perspective, probably the Coolest thing I have to tell you.
I can chime in a little bit from the clinical perspective. This last year I worked at Radial, which I guess specialized in accelerated TMS. And I feel like we were one of the first people who were implementing the Swift protocol. I am not just saying this because you're on the podcast. And as I mentioned, I'm initially a hater until I see things with my own eyes. I love the Swift protocol.
Truly amazing. It is an intervention that I saw make drastic improvements in people's lives. And I love that we were able to get things done quickly. We started to see insurance coverage, not full coverage. We had, I think, probably like two... Two insurance companies who are willing to cover it. And I saw spectacular results. It's the sort of thing that I would recommend a family member to Swift.
And yeah, I feel like I'm like hamming you guys up, but I truly saw spectacular results with it.
Right.
Yeah, yeah. And I can, I'll chime into, yeah, in St. Louis, we've been doing the SWIFT protocol also. I've given, I don't know, maybe six or seven people the SWIFT protocol so far. Yeah, very, very good results. Very, yeah, I've been impressed so far. It's been good. So yeah, very cool.
That's excellent. Glad to hear it. Yeah, yeah. And I think insurance is coming along, right? Like way faster than we thought it would, which is wonderful.
Yes. Yeah, yeah, yeah. Because it took so long for insurance to really give good coverage for conventional TMS. So I thought we'd be waiting forever for Swift to get covered and other accelerated protocols. But yeah, yes, I'm very glad. Yeah. Yeah. Yeah. Very cool.
There's people apparently now, if you look at policies, the policies that have added accelerated TMS to their policy in the last year, there's now over 40 million covered lives. And if you add some of the VAs to that, you get over 50 million covered lives. So we're pretty excited about that.
That is, yeah, yeah, it's a whole new world. I mean, I can imagine if we... Hopefully very soon we'll live in a world where virtually everybody has coverage for superior accelerated protocols. Yeah, that
would be so awesome. Are there any other protocols that are in the works or any other accelerated protocols that are in the works?
Well, at Brainsway, we're trying to do, we love to have, we do data collection studies. So all the TMS companies do this probably. So as a just PR announcement to anybody listening to this, if you have big, if you collect data from your Patients and you do any of these like off-label things, speak to your manufacturer because manufacturers often can certainly Braidsway collects, does data repository studies where people can share their de-identified data with our Braidsway data repository and that we can use that to do label expansions.
So this is how we saw adolescent depression get FDA clearance, late life depression get FDA clearance. I know that for us and some other companies there's other things in the works. So this is a really nice way actually that clinicians out there and industry can work together to like really help move the field forward. So if you're doing SWIFT or you're doing one-day TMS or you're doing any flavor of Accelerated that you'd like, certainly if you're using a BrainSway device, please reach out to me and we'd love to see what we can help you with with those data.
Cool. Yeah, Brainsway loves data. I think Brainsway has been much more of a – because when I started giving people TMS in 2013, it was with Brainsway. And yeah, Brainsway has always been much more of a – it's always been very much a science-forward sort of company, which has been nice. And I think that's paid dividends, too, because I know – at least I – The publicly available information is that Brainsway is making a small profit.
So that's good. In the TMS manufacturing business, that's a good thing.
Yeah, it is true. It's true. And honestly, it is the main reason I chose to come to Brainsway is because of their tradition of investing in research. It's obviously what I love to do. And we live in a time where we see all these companies. It's a really great time for science. Because scientists and entrepreneurs and clinicians all work together to really move the needle in clinical care, which is great.
Yeah, yeah, yeah. And I think, and not to name names, but I think, you know, some companies are very invested in science and other companies are very, you know, focused on salespeople and clever slogans
and stuff like that. So, yeah, yeah, yeah.
That's very cool. So some of this science that you guys are doing, like, let's briefly return to the rotational TMS thing. Is that something you guys have, you have a patent on that? You guys have a patent on that?
Yes. Whoa, yay you. Wow. Okay.
Wow. So that's, yeah. Any idea when that might come to market? When can I start using that for patients?
Well, right now, the way that things become commercial is that they get an FDA clearance. So the first thing we're looking at now is alcohol use disorder, like I mentioned. But we have a few other projects in the pipeline that if I told you about, I would have to tell you. And I do like you, Dr. Harvey. So I'm not going to share that.
Okay.
So, yeah. So there's more coming. But things take time. So rotational... I think it won't really be commercially available until 28, 29 at the earliest, I suspect.
Ah, okay.
It takes time.
I'm going to mark my calendar and come back to you if it's not approved yet.
Sounds good. But there's other cool innovations coming. So there will be new stuff between now and then. That's like a big leap. So standard to rotational is a big leap in what we're doing. There's a lot of other sort of smaller leaps that will happen between now and then.
Tell us about the smaller loops in terms of things that you can tell us. Where is the future TMS and what are some of those small leaps that you can talk about?
Well, so some things, so there's some new innovations that will happen with the BrainSway device. So you can think about, you'll see some changes in the Form factor. Maybe we'll have some new indications. So they'll be fun. The kind of stuff that you're used to in innovations of Brainsway will keep coming.
And some of that secret stuff you can't tell us about.
Yes, that's right. It's finding a little bit. Unrelated question.
What are some indications for TMS that are possible in the future, not specific to Brainsway? Yeah.
Blink twice if it's PTSD.
Okay. So we're very excited. I mean, we're interested in... So we just, like I said, we just showed at the Clinical TMS Society, we showed a poster on durability of the SWIFT protocol. So we're very much investing in that and trying to get insurance coverage for that to make that more of the standard of care. And potentially... When we do these open label data collections to expand it to not just potentially five sessions per day for six days, but maybe other versions of that.
So that's why we would love your data. We also presented some great data we're really excited about of deep TMS efficacy for PTSD in patients with comorbid PTSD and depression. And those data show, they kind of follow from two other publications that have been out in the last few years that show that TMS, deep TMS, has really powerful reductions in PCL5 symptoms in patients with PTSD. In fact, it's potentially more of the standard H1 protocol for depression, potentially more effective in treating their PTSD symptoms than it is their depression.
The PTSD symptoms seem to be really responsive. So we're really excited about that. You've seen a lot of things out with regards to pain. I think pain is a frontier we'll all be pressing into with TMS. So that's a really kind of great new thing. There's lots of new data coming out. There'll be new pilot projects with that, I suspect. So those are some areas where I think there's a lot of emerging evidence.
What else is exciting? Yeah, new dosing protocols. Yeah. Right now, there's a lot of, I've been really intrigued to see a lot of NIH-sponsored studies in the addiction space. So I know for sure there's an NIH There's several going on with the H4 for cannabis use disorder. There's a study with the H4 for methamphetamine use disorder. There's a study with the H7 for alcohol use disorder. There's a study with the H4 for cocaine use disorder.
And these are all things on the top of my head. So these are all NIH sponsored studies with investigators around the country. Using H1, H7, or H4, in particular in the addiction space. So I think we're going to see a lot of movement.
I think I see an H4 helmet. Very nice. Sorry, you got it, Dr. Harvey.
Oh, I was just going to say, it sounds like a lot of this research is not necessarily taking place within Brainsway, but just kind of out there in the community.
Yeah.
Yeah, which is nice.
Which is great. Absolutely, right.
Yeah, yeah. What were you going to say, Dr. Maltberg? I think I see an H4 helmet. Oh, yeah.
Yeah.
Yeah, so the insides of the coils are just the coils and then there's a helmet that goes over the top of them and there's actually like a little HVAC system. So if anybody out there has a brain sway system, that's actually what's happening is there's a little mini HVAC in that big white box that you get. And that's pushing cooled air through the helmet itself. And the cooled air goes between the helmet casing and the top of the coil here.
So yes, our dear engineers sent me just the case, which I turned into a lampshade.
That's nice. Nice.
Wow. Wow.
Oh, you know, one thing I was wondering, one more specific question I was wondering about is, so, you know, so normally with TMS, we have a lot of hesitation to give people TMS if they're active drinkers, you know, thinking that there's been increased risk of seizures. Did that give you guys some hesitation or have you seen seizures or what's, how's that worked out for you guys?
I'm so glad that you asked that question. So, yes, this is a really important conversation, I think, that's coming up a lot recently, which is great, is that alcohol is, the brain seizes when the brain is irritated. Like, that's the general premise. And the brain is irritated by change, right? And so, when we think of things that cause TMS-induced seizures, it's changing medication, right? It's Having like a change in your sleep, like basically staying up.
If you were to stay up for 36 hours, your seizure threshold's way lower. And for alcohol, it's withdrawal from alcohol. So, or perhaps like the day after a binge of alcohol. So if somebody drinks, so right now we're doing the study, but before I joined Brain Sway, my lab also did a study. It's going on since I left. They now have 100 patients. My version of the study had an additional 50 patients.
And we did TMS on people that were heavy drinkers. And people in the study were regularly drinking at least six drinks every day, maybe 10 drinks every day, maybe 15 drinks every day. So they were heavy drinkers and we had 50 people in that study. There's over a hundred in the study going on by Dr. Atticott now at Wake Forest. Heavy drinkers, no seizures. And that's because as long as you're drinking at a steady rate, there's no change in your seizure threshold.
The change is when you're, if you go from drinking a bottle of wine every day, and then all of a sudden you decide to go cold turkey. You say, I'm quitting. And then two days later, you will have a very low seizure threshold. And that's because your brain, that's the big change signal. So that, as a clinician, that's sort of the advice that's generally given, is that it's presumably fairly safe to give TMS.
The seizure risk is extremely low if they're using a substance like alcohol at a steady rate. If there's a change in the rate, then the key is to check the motor threshold. As long as you check the motor threshold on a regular basis, you'd be okay.
It's almost like a paradox as a clinician being like, we're trying to get you to decrease your alcohol, but please do not decrease your alcohol too much.
Yeah. When we started, so we started, I received a few NIH grants when I was back at Wake Forest and MUSC to do TMS for alcohol use disorder. And of course, the NIH is very, you know, risk averse. And so we went back and forth for a long time with them about what things we would have to, what safety measures we'd have to have in place. And because what happens if TMS is a miracle and you give it to them and then all of a sudden they just quit drinking?
No, they're sober. No.
I would love for TMS to be not effective for alcohol. But the reality is it's not. Yeah. And so we encourage the goal is that it was to take people who are treatment seeking and try to get them to decrease their alcohol use. And the reality is that people do it slowly because it's a habit. It's a very hard habit to break. And so organically, it generally just goes down slowly, right?
Unless they're in medical, you know, they're in detox program or something like that.
Yeah. Yeah. Oh. And in this protocol for alcohol use disorder, and you might have told me before, but I don't remember, what part of the brain are we stimulating here? Is it left or so lateral or someplace else?
Medial prefrontal.
Oh, medial prefrontal. Okay. Medial prefrontal. Yeah. Okay. Okay. This basically the same as, same as like for the same spot for OCD.
A little further anterior than OCD. So you're hitting like the pre-SMA and the media and like, you're kind of like, the pre-SMA is probably like mainly concentrated underneath the coil. Um, but you know, brain sway fields are pretty big, right? So it's, it's a wider field than that. Um, this is involved in like a mix between, um, Craving based or hedonic responding to alcohol as well as habit based responding.
So we know that as somebody starts when people are young and they start to drink, usually they're drinking for the euphoric effects of it or like for the acute effects of it. They're trying to get something out of it. Right. When the more like older drinkers, alcohol is typically just become like it's just become a habit for them. Right. So like a standard that they get home, they open the door, they see the refrigerator, they open it up, they see that vodka bottle there.
They take a sip. They say, I had a hard day at work. I'm just going to have one today. They've done this every day and they drink the whole thing. Right. It's just all it's very ritualized. And it becomes hard to break, which feels a lot like an OCD patient. There's a lot of overlap there with habits and rituals and repetitive behavior.
Are you guys considering doing any studies for patients addicted to decaf coffee?
Well, maybe you can find somebody out there to sponsor it.
While I'm asking important questions, my wife requested that I ask this question. Dr. Hanlon, can you get me a Brainsway machine? Sure, of course.
I'll direct you to this hospital. I was hoping you would just give it to me.
I didn't want to have to pay for it. No, I make a joke, but... Pricey,
pricey.
Yeah, I'm a huge fan of Brainsway. Yeah.
Yeah. Yeah. Great.
Cool.
Cool. All right. Yeah. It's a really fun time in the world of TMS, actually. Thanks so much for having me on the podcast.
It's, you know, I
think we really need more, we need more of this, right? I think people are hungry for learning about it and all types of ways that we can reach the public. Yeah. Thank you.
They are, they are, yeah, yeah. And there's so much going on and so many new things happening and it's all, yeah, it's all stuff people want to know. I mean, this is, yeah, like you said, people are hungry for this information. Yeah.
Thanks so much for joining us. As soon as there's more information that you won't have to kill us to tell us, reach out and we'll have you on again. This is fun. Okay.
Yeah, yeah, yeah.
All right. So we'll go ahead and wrap up here. So thanks for being here, Dr. Hanlon. And to the audience, thanks for joining us. Thanks for listening to our podcast. Hope you enjoyed it. And if you didn't enjoy the podcast, then just keep listening, I guess, because it's probably an acquired taste. Yeah, yeah. We have a snarky remark of some sort at the end of every episode.
It's a trademark.