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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.
