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Foreign. Let me make it very clear from the start, my voice is hoarse. Not because I spent all of New Year's Eve partying it up and yelling at the top of my lungs, quite the opposite. I was in bed, like by 9:30pm Because I've got my typical annual cold that it's predictable. Every year I get it, though. I get the flu vaccine. We know that this year is just not very good as it has been for the last several years. And so I'm recovering from this viral issue, and it is what? We're recording this on the first day of January 2026. Now, my producer said, let's not do it. You sound terrible. But true to form, and because I am as stubborn as I am dedicated, I said, no, man, it's the first of the year. We have to do it. It's our tradition. Because we're gonna kick off the year, right? Happy New Year. Happy New Year. Yep. And I said, look, I know I sound terrible. It's all right. It doesn't matter. I don't care. We're gonna get this thing done anyway. So much to my producers dismay, we decided to get this going on the first day, year 2026. So just for everybody, happy New Year. All right. All right. So anyway, yes, I could have definitely. We could have absolutely have waited to do this. However, as it is the start of the new year, we wanted to start with some brand new information. See what I did there? See what I did there? Because it actually ties in very nicely to women's health, though it's not specific to women's health at all. Even though we, as women's healthcare providers definitely take care of this issue, which we're talking about mood disorders in women because. And guys, don't be mad at me. I'm just giving you the stats, right? Even the CDC says female depression and female mood disorders has a 2 to 1 female to male predominance. At least it does here in the US And North America. Okay? So we are relating this because we take care of women and patients that we see, whether it's a standalone issue as a primary mood disorder or as a secondary issue because of something like chronic pelvic pain, which we just talked about, or infertility that can come with depression. We know that PCOS has a high prevalence of depression. So we see this, guys. So because it's the first of the year, we wanted to do this justice by talking about something that's a first for FDA approval. That's kind of nice, right? Kind of fit in Nicely there. And this has to do with something that is actually a little odd because we don't usually think about at home electrical shock therapy. But this is the thing. And this actually got approved in the middle of December 2025. And when I saw this come out, I'm like, you know what? That'd be a nice brand new year thing as we kind of look to new developments, new hor, new technologies. So we're going to discuss this brand new headset that works with an app that will be available later on now. This year, 2026. All right, this year 2026. Now, as a disclosure, I have no financial interest in this headset or in the manufacturer, which we'll talk about. And we're going to talk about the data because the data can be a little controversial because there was one study that said, dude, shocking your brain, no better than sham therapy. This was on an RCT. We're going to cover this in 2023. But there's a key difference between that study and the one that got it. It's FDA clearance slash approval, which was a phase two study called the Empower trial. All right, so what I want to do here is we're going to talk about this brain zapping headset at home that the FDA just approved. So it's first of its kind at the first of the year. Even though, let me say this right now, guys, we have a global audience. If you are listening to us through the UK or Switzerland or even Hong Kong, you may be thinking, wait, a zapping headset for depression? We've had that for a while and true you have. So this is new to us, guys. Okay? This is new to us. However, those places I just mentioned, Europe, uk, Switzerland and Hong Kong, have actually had this device for some time, even going back to 2019 or so. Okay? So it is new to us, but not new to the global population. So we're going to cover this new at home device. Again, not a sponsor. That's Flow Neuroscience. That takes a Look at this. FL100. FL as in Flow Neuroscience and manufacturer FL100, which is direct stimulation. Actually, it's transdermal direct stimulation of the right and of the left dorsolateral prefrontal cortex. Now, if you're thinking, am I supposed to zap myself at home? Yeah, absolutely. But it's just a little. Guys, we're not doing home ECT here. And don't go jump hook yourself up to your jumper cables to my buddies down in the south, down in the Mabario of Texas. Don't don't connect yourself to, to your 12 watt. Okay, this is two milliampules for 30 minutes per session and it's going to take a while, guys. And that's the catch is that the evidence where this shows benefit is this is with prolonged therapy, meaning 10 to 12 weeks either as. Now listen to this, guys. This home brain zapping little headset is either a standalone for major depressive disorder or even if they are on an antidepressant medication or, or undergoing psychotherapy. So the trial said for all of those, let's check it out. So either no therapy, in other words, as a standalone with medication therapy or as psychotherapy. This used as an adjuvant, even though it's not perfect, does show some moderate benefit here. So we're gonna talk about this. This actually is based in real science. There is actually electric field simulations that have actually looked at this where you wear this headset that you control it with an app. And yes, it definitely targets what it says it targets, which is the right and left dorsolateral prefrontal cortex. Remember, that's the area that's involved with anxiety and mood regulation. Okay, so phenomenal. I think this is brand, I mean, just mind blowing, no pun intended, as these head nodes connect to the head and deliver little micro jolts. Two milliampules for 30 minutes. We're going to talk about this and we're going to walk down the data guys, very quickly because I don't know if my voice is going to last from 2023, 2024, that's what got it approved by the FDA. That's called the Empower Study. And then 2025, because watch this, guys. Don't ever think I'm not telling you something that's hot off the press because on December 13, 2025, we just left December. There was a brand new systematic review and meta analysis that looked at this very thing, that of Scientific Reports, a very reputable journal. So again, on December 13th, I'm sorry, December 15th. Thank you, Michael. 15th, 2025, out of Scientific Reports, this brand new systematic review and meta analysis said, does this thing work at home or not? Can. Can you really zap your brain at home and feel better or not? So we're going to answer this when we come back. This is Dr. Chapa's obgyn no spin podcast.
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I don't know if I'm gonna be able to finish this thing today. I don't know. It's already late in the evening on January 1, 2026, and I don't know if my voice is gonna do it, but if I don't do it now, I know it's gonna happen. It's gonna get worse. I'm gonna go into my post call because I'm actually on call. Yes, I wash my hands a lot. Yes, I cover my mouth, my nose, wear a mask when I go and see patients. I'm not infecting everybody. And I keep a distance. I. So it's all right, trust me. But I got work to do. But I just keep. I keep my space, so I'm not putting anybody in harm's way. And I'm telling you, man, I mean, I was at the hospital today. We had team lunch. I kept my distance, and I'm just so proud of our team. So if I have to work, which today I did on January 1, 2026, the group of residents that I had, phenomenal guys. I mean, top notch. And so I just can't complain. Having said that, I feel like poo. And I don't mean like the nice poo. I mean, like the bad poo. And even from our podcast team, I mean, two people in our podcast team, they're like, brother, you sound terrible. Let's not do it. But I convinced them. So we're gonna knock this out. It's very easy. Look, guys, brand new headset delivers very low amplitude energy for sessions of 30 minutes at home through an app, either a solo therapy or as ancillary therapy, whether for medication or psychotherapy. And it does seem to work. And all I want to do is very quickly go through three years of data because they are consecutive, and that's very unique. 2023, 2024, which was a phase two pivotal study that got its FDA head nod, and then the one from literally two weeks ago. So if a patient asks you, hey, can you write me the prescription? Because it is a prescription for the little headset so I can zap myself silly. You don't go, What? You go, oh, yeah, you want to zap yourself silly? Knock yourself out. Michael, what is that? That I asked him for electricity sounds. That's. That's what we have. Did we pay for this? I don't like it. Stop. Stop that. Stop that. All right, if that. If we paid for that, ask for a refund. I don't find one more time. Oh, my goodness. Look, we're not giving somebody electrocution. For heaven's sakes, Mich. These are. This sounds like I'm connecting somebody to, you know, a torture device. Anyway, yes, Giving your brain electrical stimulation, guys, is a deal. Listen, there's electrical impulses for the vagus nerve for anxiety. The whole idea of electrical impulses for pelvic pain, for example, is the inner stem implant. So we've used neuromodulation for a lot of things. Guys, this is basically what this is in the brain level. This is big deal. Neuromodulation, hitting the prefrontal cortex to kind of rewire the brain. So this is the old ECT kicked down a notch for home use. Oh, my goodness. So, yes, this is. This is by a prescription. And again, good data here. So the FDA said, look, it seems to be of moderate benefit. It's not great benefit, but moderate benefit with side effect being maybe a little bit of skin irritation by the anode, maybe a little bit of headache. Mild headache with this thing. And you got to stick with it for 10 to 12 weeks because shorter term duration, like, six weeks, didn't seem to do much. But if you're committed to do that for, like, five treatments a week to start, and then you can cut that down to three treatments a week thereafter, if you're committed to do that. Why not? And here's what I think, guys. Look, you know, I really feel for parents who have sons or daughters who are, you know, teen slash early adults. If they're suffering with horrible depression and nothing else is working, by the way, this is unipolar. This was not for bipolar. This was unipolar major depressive disorder. Okay, Maybe a little bit of anxiety thrown in there. This is not for bipolar schizophrenia. But if you are, if they're at their wit's end because, like, they've tried things and it hasn't worked, I'm all for it, man. Why not? And this is now FDA approved. Maybe a little zappy Zappy of the brain. Maybe that will do it. They just got to stick with it again for 10 to 12 weeks. So if this thing shows promise, as it seems to internationally, because even though it's new to us, the company said that there's over 55,000, 55,000 patients who have used this device from 2019 to now across Europe. Again, entire U.K. switzerland, and Hong Kong. Why not? So the FDA did approve this. If you're asking about cost, I got that for you. It's about 500 to $800. Even though they are petitioning right now, Flow Neuroscience is petitioning to get this on insurance plans. So why not? If this thing works, great. We just need to make sure that, you know, patients know its limitations. And again, it's not for all kinds of mental disorder. Just for major depressive disorder in adults. Now, that's the one catch. I said, you know, late teens. But this was FDA approved, right? For those who are 18 years of age and above. Right, 18 years of age and above. Now, for those that are on medication and it's not working, another option is to add another medication. But then you're like, well, how many meds am I supposed to take? And this is why this has the appeal, because it is non pharmacologic, but things like Regzolti as a boosting agent to help a regular antidepressant medication that has data also, again, Regzolti, not a sponsor. So very quickly here, guys, because I. I don't want to belabor this, because heaven knows, I. I don't have the strength to do it. We're gonna keep doing this whole sound the whole time, aren't we? Oh, I like that one. That's like, all sparky. All right, stop. Stop my. Yeah, we're done with that. Okay? Plus, that sounds terrifying. This is not what that sound is, right? This doesn't make a sound. It's right over the pre. The head and the right and left side and small little pulses of energy. All right, so let's start with the Lancet 2023. The Lancet 2023. This looked at an RCT, guys. This was triple blind. How about that triple blind sham controlled, multi center trial that looked at transcranial direct current stimulation. That is Little T. DCS Little T. DCS Transcranial direct current stimulation. That's what this thing is called. Okay? The title was transcranial direct current stimulation as an additional treatment to selective serotonin reuptake inhibitors in adults with major depressive disorder in Germany. Okay? So even though it's multicenter. Not us. But this was in Germany, remember? Lancet 2023. As they stated in their objective quote, we aim to assess the efficacy of D D of T. DCS versus sham stimulation as an additional treatment to a stable dose of selective serotonin reuptake inhibitors in adults with major depressive disorder. This was 150 patients, as you would think. The majority were female. So that was 59% were female. The remainder, 41% were male. And the short answer was, quote, active transdermal direct current stimulation was not. Listen to that, guys. Not superior to sham stimulation during a six week period. Quote, our trial does not support the efficacy of T. DCS as an additional treatment to SSRI in adults with major depressive disorder. End quote. So this is the, the poo poo one. This is the one that's saying, doesn't work. No better than sham therapy. But here is the catch. Okay? So I'm telling you guys, I'm here to give you the entire info and then you make your own decision. And this is why when you, when you read an abstract, which is great, the abstract is a movie preview. I've said this many times before, like, oh, that looks so good. And then you read the entire manuscript and you're like, limitation, limitation, bias, bias. So you got to read through it. Because if you just read this conclusion, no better than sham therapy. I'm just going to give patients SSRIs by themselves because this didn't work. Okay? However, the duration was for six weeks. So hold on for a bit. Okay, so that's the catch, is that in all of the other studies. And again, remember, I'm not trying to, you know, give kudos to flow neuroscience, although I, you know, good for them. They did come up with something novel. But I'm just trying to be fair to the data that after that it seems that you need therapy for about 10 weeks to show a sustained response. Okay? So this is why. So if somebody asks you, hey, does transcranial, does transcranial slash transdermal direct current stimulation, does this work? Your answer should be, well, only if you do it for the appropriate duration, because it needs to be at least 10 weeks and it's got to be dedicated to do these multiple treatments. But in the Lancet in 2023, there was this publication that said, yeah, no, better than sham because he probably used it in a short amount of time. Now let's move forward from that to 2024. Okay? So 2024, this is what the FDA based its approval on. This Was the. There it was. Oh, you see that? Hold on. That was an alveoli. Just came out there. All right, I'm good. Oh, good Lord. As proof that I'm sick, guys. But in commitment to this darn show, I said we're going to do it. All right, here we go. Michael, where is my thing? Oh, all right. So this is part of the US phase 2 study for the Empower study. Oh, one more. Hold on. Goodness gracious. All right. Oh, my goodness. Sorry, guys. Oh, this reminds me of something real quick. We get a variety of comments through the show, either through our Spotify account or through social media, and some of the comments have the same kind of recurring theme. And one of those themes is, you know, I appreciate that your podcast seems to be real, okay? And I don't mean real like we're fake. I mean real in terms of, you know, the way that we talk on the podcast, the way that we talk to our friends, to the residents, to our peers, to other attendees, to fellows, whatever. This is who we are. We don't try to put on airs. Because I've heard some podcasts, guys, some. Some medical podcasts that are so sophisticated, they're so. They're so. They're so up in the air that there's just no clinical value. And this is why burnout became a thing, because it became so lofty, man. We just. We're trying to be real, you know, we're not putting on airs. And so if there's any doubt that you get kind of raw us on a raw me on the show, it's me coughing up in a bronchos during this. So, so sorry about that. My goodness. Okay, so what the hell was I. Oh, yeah. So the Empower 2. Thanks, Michael. So the Empower study, once again, fully remote, multi site, double blind, placebo controlled, randomized for 10 weeks. This is home therapy in major depressive disorder. And yeah, it did work. Again, more were women. 120 was the end for women 54. 4 were men. So more than double the participants were female. As is true in the population and epidemiological studies. There it is, that two to one ratio. Okay, so yeah, whether they were on antidepressant or psychotherapy or nothing, this seemed to work in a decrease of either clinician obtained or patient self graded survey on a depressive scale. So this is good. So this is the one that the FDA said, hey, no big side effects. This had a moderate reduction here using the Hamilton Depression Scale. Why not? But again, each session, guys, let me tell you this Is you gotta be dedicated for this thing. Each session, 30 minutes, one little anode goes over the left dorsolateral prefrontal cortex. The other, the cathode goes over the right dorsolateral prefrontal cortex. So you've got the cathode and the. All right, so babies like jumper cables, right? So you gotta make sure that you know which one is which. The anode is placed over the left dorsolateral prefrontal cortex and then the cathode on the right. So positive on the right, negative on the left, and then it's active treatment to the prefrontal cortex for those 30 minute durations. Okay, and this did help, but again, they had to use it for 10 weeks now. So we have one in 2023, say no better than sham. But it was only for six weeks. We've got this study that said for 10 weeks this had better efficacy. And this was in the journal Nature Medicine, again, very well respected journal. So we have a yes and a no. It would be nice if we had a referee. And lo and behold, folks, we have the referee because that referee happened just about two weeks ago in the middle of December 2025. In scientific reports, RCTs with a total N again, not huge numbers, but still very respectable of 415. 415.
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So five RCTs looking at this in a systematic review and with a meta analysis. And yeah, sure enough. And they found compared to a sham, the depression scores were moderately improved. In other words, the scores were reduced. And so their conclusion was sure, even though some results remain mixed and even though we need larger, more standardized trials, this can be considered either as a standalone or as an adjuvant slash ancillary for other therapy. So an anode and a cathode over the prefrontal cortex in 30 minute settings for multiple days initially as a kind of, as a loading slash initiation and then you drop those down to three times a week for the duration. So this is, you know, it's a lot of dedication do this, but, but I hope that this is what it says it is. And the data from international studies kind of does support that. So as of right now, Flow Neuroscience plans launch this in the second quarter of 2026. It is by prescription only. It's about 500 to 800 bucks projected. But they are working with insurance coverage and they should know that in the beginning of the first quarter of this year. Now, 2026. Okay, so if it's able to help somebody, why not? So can you self zap your brain for better mood? It seems that you can, absolutely. As long as you understand that it's, you know, not a dramatic. It's a modest increase in in mood or a decrease in in score in the depression scale. And why not, if it's going to make you feel better? Zap away, baby. Zap away. All right. So. All right. Thank you for putting up with my big mucus plugs here in my chest. And I got through it. Anyway, looking forward to new things in 2026. That's why I wanted to highlight this, because it's new for us. I don't mean us in the podcast. I mean us in the country for the us. And we're all about letting you know what's hot in press and hot also on the commercial side. So, as always, we're thankful for you. We're glad you're part of our podcast community. Michael, you want to do one more? Let's do one more. All right. My goodness. All right, stop that. Podcast family. We'll see you on another episode now in January of 2026. We'll see you on the next one. All right, Michael, let's get out of here. I feel terrible. Let's take it home. This has been Dr. Chapa Zobichyn, no Spin podcast podcast family. Thank you for your support. Support. Thank you for listening. And as always, we'll see you on another episode of the no Spin Podcast.