#142 The Vagus Nerve and Stroke with Sarah Blair

It feels like in every practice area, the importance of the vagus nerve is being talked about.

But nowhere is it being researched as much as vagal nerve stimulation post-stroke. And the initial results are promising — as long as it is paired with rehabilitation. The stimulation sets the body up for new motor learning, but then the rehab actually creates the change.

In this beginner's course, I'm excited to talk to Sarah Blair, OTR/L  from Vivistim about what she has learned about this relatively new intervention and what generalist OTs need to know about this option.

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Transcript

SPEAKER_00 0:00

It feels like in every therapy practice area, the importance of the vagus nerve is being talked about. But one of the areas where it's actually being the most researched is vagus nerve stimulation post-stroke. And the initial results are promising as long as the stimulation is paired with rehab. What we're finding is that the vagus nerve stimulation sets the body up for new motor learning, but then the rehab actually helps create the change. In today's episode, I'm excited to talk to Sarah Blair, OTRL from Vivistem, about what she has learned about this relatively new intervention and what generalist therapists need to know about this option. So let's dive in. Welcome to the OT Potential Podcast. I'm your host, Sarah Lyon, OTRL, and I wanted to let you know that this podcast may qualify as continuing education for you. You are probably listening to this podcast on a free podcast platform. But to gain CEU credit, you will need to be a member of the OT Potential Club, our OT continuing education platform. You can go to OTpotential.com to learn more. Okay, here we go. As I mentioned at the top, we are joined today by Sarah Blair. Sarah is an experienced occupational therapist with subject matter expertise spanning from neurological, infant, and burn rehabilitation. Sarah previously worked at Riley Hospital for Children for five years and has also held roles in private outpatient and early intervention settings, building a well-rounded foundation across the spectrum of pediatric care. Sarah is fascinated by neurorecovery and neuroplasticity. She joined the Mobia medical team in December 2025 as an Indiana therapy development specialist, bringing her passion for connecting clinicians and families with innovative treatment options for those searching for continued recovery. As a financial disclosure, I wanted to let you know that Mobia Medical is the creator of Vivistem, which is who Sarah works for. Vivistem is a first and only FDA-approved implantable VNS device for stroke rehab. But that being said, I just truly believe Sarah is the best person to connect the advances in this new health tech category to real life therapy practice. So without further ado, we will patch Sarah into our live studio. Hello, Sarah. Welcome to OT Potential. Hi, Sarah. Thank you so much for having me. I'm super excited to be here. This is truly an exciting topic. It's not that often that we get to talk about just a relatively new intervention related to rehab. As I look at this space, I'm I'm just, yeah, I'm excited about it. I feel like it brings visibility to the science of rehab, to the importance of that high repetition task-specific practice that we talk about a lot on the podcast. It talks, uh it brings visibility to the importance of um vagal tone and getting the body like in the right space for learning. And I'm also just excited because it is bringing investment into rehab, having this health tech solution to pair with rehab just has brought, it feels like new players into this space that's so important. Helping people post-stroke is uh such just important on the global agenda. So um it's exciting to see real advances in this area. We have so many fun details to talk about today, about the science, about what's out there. But I really want to begin with just hearing your story. Like I know that you've spent time as a practicing OT, then have been on this health tech journey. I'd love to hear about that and then how you ended up in this vegas nerve stimulation space.

SPEAKER_01 3:54

Yeah, sure. I'd love to share a little bit. Um, yeah, so I'm an OT and a big part of my early background, like you said, was in PEDs, um, worked in a bunch of different settings with a wide variety of diagnosis. And I saw, you know, firsthand how every patient's story and recovery path is so different. I've always been a why person. So, like, why are we doing this way? Why does this work for one patient, not another? And then over time, I realized that, like, while I loved patient care, I really also wanted a broader reach and became interested in how to support therapies and programs and systems, not just one patient at a time. I realized I was really excited about health tech and medtech and got involved with an AI-assisted documentation system and worked there, got some really great experience there. And it just really opened my eyes to what else was available that I could do as an OT. And with through that, um, I was exposed to Vivistem and it really clicked for me. It really brought together my OT background, uh, love for neuroplasticity, functional recovery technology. And then it keeps good, skilled therapy at the center and as the central part of the recovery and treatment option. And that is so exciting because it is such a good fit for occupational therapy, and and occupational therapists have to be central to this role. Uh, so that just find that so uh validating and exciting and empowering to be a part of.

SPEAKER_00 5:28

I love when um OTs get to transition to health tech companies. It's such an important role to have people with that uh practice experience at these companies. Can you tell us just a little bit just about your role at Vivison, just to help orient us a little bit more to what you're doing day to day? Absolutely.

SPEAKER_01 5:48

So I am um the therapy development specialist for the Indiana, Indianapolis region territory. And my job is really to connect clinicians, patients, and their care partners with Vivistem Therapy through education, um, awareness events, uh really getting into the clinic spaces to see how their therapy spaces are working, um, figure out best ways to get those patients that need therapy, need Vivistem therapy as an option uh connected with care. So from a day to day, it it varies, but I am very often speaking with patients, connecting with therapists in the clinic, watching treatment sessions, training on how to get uh the actual therapy protocol going, um, doing refreshers on good quality neuroassessments for patients. So I'm really able to still be a part of the therapeutic process, which is so exciting for me, um, while being able to help people connect with this really new and exciting intervention.

SPEAKER_00 7:04

So much in health tech, we hear about the hope of finding the things that really augment therapy. And I think what makes me so excited looking at this technology is just a true augmentation, a true supercharge of what is happening in therapy. I have just like a billion logistical questions about what that looks like, but I want to start us just at um the highest level of the understanding the vagus nerve and the role of it. It's really interesting here on the podcast, as I get to talk to experts in different areas. I actually hear a lot about the vagus nerve in all kinds of different practice areas. I think there's a huge trend for therapists in beginning their session with some kind of activity that uh really sets the vagal tone. So, like um deep breathing or some other health tech device to really get the body into a state of learning. Let's just say that's all I know. Can you walk me through 101? Why are therapists doing that? What do I need to know about the vagus nerve to understand this conversation that we're about to do? Yeah.

SPEAKER_01 8:18

Absolutely. Um, so you know, if we're talking vagus nerve 101 here, I'll say that the science is still evolving a lot. Um, and there's not uh we're right at the beginning of understanding what the vagus nerve is involved in. Um, but the simple area answer is that it's involved with a lot. Um, we hear about the vagus nerve in wellness spaces a lot. Uh, you know, you're we're seeing cold plunges and we're seeing ice packs in the center of the chest, and we're seeing uh deep rumbling noises to sort of stimulate the vagus nerve. And while that's all super exciting and fascinating, there are areas of vagus nerve stimulation that do have like decades of medical and neuroscience research behind it too. Um so that's sort of what what we'll be talking about today, uh, how that's evolved to incorporate into stroke recovery. So you might know that uh the vagus nerve is often associated with the fight or flight, rest and digest, um, but it is the longest cranial nerve in the body, and it's a major communication highway between the brain and the body. So signals are running both to the brain with through the left branch of the vagus nerve and to the rest of the body, including the heart, uh on through the right branch of the vagus nerve. But it's got big plays a big part in regulation generally, getting you up and ready to do something exciting or calming you down afterwards, um, stress regulation, heart rate, digestion, sleep, all of those things. I didn't realize before learning about vivistem how how important it was for your brain processes, um, executive functioning, attention, learning, memory, neuroplasticity. So it was really exciting to learn about that. What we know is that stimulation to the vagus nerve sends signals through brainstem pathways, which can influence and help release neuromodulators in the brain, uh including norepinephrine, serotonin, acetylcholine. So, you know, it's not activating the arm part of the brain to help the arm move, but what it's doing is it's activating and helping to turn on the learning centers of the brain. So that therapy at that point, your high-quality neuro rehab therapy and principles are even more effective. So you're priming your brain to be ready to learn new things and rebuild, repair, reroute neuropathways that were damaged in a stroke. So with paired VNS, the stimulation is paired with movement. That's where the paired VNS comes from. And it's almost like telling the brain, hey, pay attention. This movement is important. And so it's like uh, hey, brain, pay attention. I don't know if if snaps go through on podcasts, but um, you know, pay attention. This is important. Um, this is something that you want to learn and want to really integrate. So the key takeaway with with the vagus nerve is that the VNS is not making the muscles move and it's not replacing therapy. And it doesn't work if the therapy is not taking place at the same time. So the therapy still does the work. The therapy is the therapy, but the VNS may help enhance or does help enhance the brain's ability to respond to the therapy and um makes it become more effective.

SPEAKER_00 12:02

What a great way to put all that. Um I'm trying, I'm trying to wrap my brain around it. I'm even just trying to wrap my brain around like the language that's being used. I want to ask just a couple of language questions. Yes. Is the goal you would say to like stimulate you're trying to stimulate a vagus tone that is in learning mode? And is that in rest and digest mode or kind of activated? Uh what's like what are I guess the words that you use around that?

SPEAKER_01 12:39

Yeah. So I I actually don't use the word vagal tone too much. And that may be something that I can I can look into further. Um, but the way I think of it is actually how I think about um preparation for a pediatric session too. So what I want to do is focus on regulation and connection first. So with PEADs, those are things like that's proprioceptive input, that's heavy work, that's um making sure that we're we're connected. It's the same idea. We are priming the brain's ability to be ready to learn. If we don't have regulation first, we're not gonna be able, the other things won't stick. So what the what the vagus nerve stimulation is doing is releasing those neuromodulators, which is basically just turning the brain and into it, putting it into a heightened learning environment.

SPEAKER_00 13:34

That totally makes sense. Is just really helpful to like conceptualize it in that way. I want to ask next about some of the research that's come out. As you've mentioned, this has been studied. Uh, vagus nerve stimulation has been studied for a long time. There's been this renew, this new focus around post-stroke rehab. I pulled one of the most recent systematic reviews that came out. It's called The Effect of Vagus Nerve Stimulation on the Rehabilitation of Stroke, a systematic review and meta-analysis. It just came out uh this winter of 2026 and kind of walked through the state of the science, just to say out loud for people who uh don't have this article in front of them, which uh probably no one does since they're listening to this podcast. But uh it launched with this idea that vagus nerve stimulation has already been an established intervention for epilepsy, drug-resistant depression, pain, and chronic tinnitus. And then in 2021, the Food and Drug Administration approved the first paired VNS device for patients with moderate to severe upper limb dysfunction following an ischemic stroke. So it entered into this post-stroke post-stroke area with those parameters around it. That's for ischemic stroke and for that upper limb dysfunction. Then uh the goal of the study was to look at the um effect on that group of people, and they looked at multiple uh randomized control trials, 16 of them with 819 patients. They were looking at ADLs, swallowing function, and emotional state. And what the study found was significant improvement in upper extremity function through the Fugelmeyer and Wolfmotor test, significant improvement in ADLs through the Barthel and modified Barthel, significant improvement in stroke post-stroke depression by the Hamilton depression rating scale in HADS, and then no significant improvement in swallowing. Um, but the numbers on swallowing were really small in the systematic review. So that was kind of uh kind of summarizes the current state of the literature where we're at the point where we've had multiple randomized controlled trials. They're being able to pull the data into meta-analysis, and they're seeing this just like across the board positive improvement. When I look at the study, I just see this like growing body of evidence behind this intervention. I'm curious with your eyes and your expertise as you look at this, like what stood out to you in this latest research?

SPEAKER_01 16:25

Yeah, so I think what jumps out to me most is just the consistency and the growing interest across the literature. So it's not just one study or one isolated result. We are really seeing with pretty high confidence that vagus nerve stimulation is very beneficial for stroke recovery. And that is extremely exciting. And then also, you know, the benefits weren't just limited to motor scores. I really liked how they looked at things that were especially meaningful for patients, their ADLs, their functional goals. They looked at mood and, you know, depression and all of those things. And I think that that's super important to take into consideration as occupational therapists, of course, that we are looking at the whole person and we're not just looking at how well the arm can move after this. I also felt like it was interesting uh that there were so many transcutaneous approaches that were included as the only FDA-approved option is the implanted paired VNS. So that is uh, you know, uh an implant that is is connected directly to the vagus nerve that is able to offer um stimulus at the specific time of therapy. Uh, and then, you know, because no evidence evidence is not all the same across the board, um, different stimulation parameters, therapy protocols, and populations, there's different device approaches. So we have to look closely at what's actually studied to really tease apart all of that data. And then I also did want to mention that a study that wasn't included, if that's okay. Uh, we have uh the pivotal trial that led to the paired VNS FDA approval in 2021, published in The Lancet, was a multi-center randomized, triple controlled or triple blinded, sham controlled, uh, impaired with a standardized rehab. So the rigor of the actual research is pretty high. Um, and we were able to see with all of those controls in place, how the paired VNS was able to assist in the improvement of upper extremity function. And then I think the last thing through all of this as an OT, what resonates for me mostly is that the vagus nerve stimulation was not used instead of therapy. Again, it was paired with intensive rehab, high repetition, past specific practice and meaningful movement. And that's like that's our whole shtick, right? You know, we know we know what works for neuro rehab, and you know, it's very exciting to see that the research is backing up that this therapy approach works, and here's a way to make it even more effective. Um, so you know, we're not working on trying to replace therapist or rehab with this device. It's something to potentially help patients get more work, get more from the work that they're already doing.

SPEAKER_00 19:35

It's so interesting how it, as you said, just like supercharges what's already going on. And I really want to drill into that um what they call like the mechanism of action, because I don't fully understand it yet. What the article said um uh at the end, they talked about the mechanism of action, which they're they're like, we're still exploring exactly why this works, but it seems like the three general things are stimulating the vagus nerve, creates this anti-inflammatory and neuroprotective effects. It enhances neuroplasticity by regulating neuroepinephrine and serotonin, which you mentioned already. And then there it also just does this network modulation, um, influencing brain connectivity and cortical excitability. So walk me through. I just want to understand like exactly what's happening. So here in the United States, you get an implanted device. Where's it at? How does it get like triggered? What do we think is happening as you're explaining it to people? Like, walk me through the logistics of what's happening here.

SPEAKER_01 20:52

Sure. So, what we know so far is that this is effective for adults with chronic ischemic stroke that have a moderate to severe upper extremity deficit. So these patients are going through several steps of um evaluation and approval. And then once they get evaluated by an occupational therapist or a physical therapist and get surgically cleared and have the surgery, um, the surgery itself is it's two incisions, one usually on the left chest and one on the left neck, just a couple centimeters. Um, it's an outpatient procedure and the patients go home the same day. There's a IPG or a little uh connective battery generator that is put in the chest. And then there's a lead that goes up and coils around the vagus nerve, the left vagus nerve. Specifically the left vagus nerve, because 80% of those nerve fibers are afferent and are going to the brain and talking to the brain for. Versus the right vagus nerve, which goes to the body, including the AV nodes of the heart, and we're not wanting to mess with those. So we always connect, always connect to the left vagus nerve. And then in terms of the stimulation, like you said, there's probably several things that are happening at once that make this effective. What we know likely is happening is that signals from the vagus nerve are traveling through the brainstem, specifically through the nucleus tractus solitaris or NTS. And then from there, the pathways connect with areas like the locus cerelius, the raffinuclei, and which, and those are the things that are involved in releasing norepinephrine, serotonin, acetylcholine, things like that. What we know about those chemicals is that they're tied to attention, learning, memory, neuroplasticity generally, and they help the brain to recognize what's important and what's worth learning. So when you're giving those stimuli at the same time as completing the high-quality neuro rehab, you are getting the benefits of those neurorehab principles, high repetition, salient, mass practice, variable, plus your brain is ready to receive that learning. And then what that actually looks like in practice is the patient has the device implanted, and the clinician has uh a computer. We call it the SAPS with a transmitter that pairs with the patient's implant. And then they have a clicker. So they can actually physically click to send stimulation to the vagus nerve at the most important part of those movements that uh the patient wants to recover or relearn. So it's very interesting and very precise how we're able to send those signals to the brain to say this part's important. And I just find that extremely fascinating because you're you're working in that precision piece where you can really focus in on the parts of the activity that are that are important, um, even more so than your basic parts practice uh within a task. So it's it's very, very exciting. And then that's that's where the pairing is important, right? The stimulation is delivered during those movements and not randomly throughout the day, not when you're sitting on the couch and watching Netflix or or you know, during when you're sleeping. So you're doing you're getting the vagus nerve stimulation at the same time as the movements. So it, you know, it it recovery requires the brain to relearn the movement. Uh so therapy provides the practice and the vagus nerve stimulation helps to create the brain state to be more receptive to learning from that practice. And it just is it's really exciting that we're able to again be able to be really specific about when we're providing the stimulation in clinic. And then additionally, patients will receive a magnet that they are able to swipe over their device for home practice. And so that provides them up to uh eight 30-minute sessions throughout a 24-hour period of time that they're able to swipe before morning routine, before daily housework, before cooking, before their leisure activities. So, in on top of high quality neuro rehab principles that are happening in clinic at a pretty high frequency therapy, we're also getting a really super functional patient at home putting in the work while getting vagus nerve stimulation through the magnet and home program.

SPEAKER_00 25:57

Wow, it's also mind-blowing to think about how we're able to harness this brain state that we've known opens the door for new learning. Um, and then to also think about stacking it on top of like if you're post-stroke, especially in those first three months, you're already in a state of heightened neuroplasticity, and then you're able to heighten the potential learning even more. I am very curious about the role of the therapist. Some of my questions are: do they need special training? Do they get approved beforehand? It sounds like uh you would be doing therapy that's really familiar to any stroke therapist. Um, but what can you tell me about the partnership with a therapist and what might be different than a stroke patient who doesn't have this technology?

SPEAKER_01 26:51

Yeah, good question. I want to uh bounce back for one second and just give a quick clarification for what we've studied so far is the effects of paired VNS therapy in the chronic stage. So we haven't looked yet at the implantable vagus nerve stimulator in the acute phase. And we haven't, we haven't really wanted to mess with the spontaneous recovery that's happening. And instead, waiting until recovery slows down a little bit and reboosting the rate of neuroplasticity or a neurore rehab at that point. So we're sort of letting letting uh acute rehab do its thing and spontaneous recovery do its thing, and then coming in and giving another boost so that that recovery, that quicker recovery is prolonged as long as possible or as long as the patient needs.

SPEAKER_00 27:39

Super interesting. Yeah, that makes sense to study it in that phase when you're in a plateau and it's quote unquote normalized, so you can really see the effect size. Absolutely.

SPEAKER_01 27:48

And we're, you know, we're right at the beginning of the research. Who knows in the future where all we are able, we're gonna be able to go with this. Um, but it is it's exciting that we have such positive results with these first couple of studies that have come out. Back to your question about training for the therapists. Um, so like you said, with Vivistin, the therapy that is occurring is high-quality neuro rehab following the principles that therapists are already using for neuro rehab therapy. Um, specificity, repetition, intensity, salience, variability, transference, all of those things that should be very familiar to a neurotherapist. Those are the things we're doing during treatment. So that part, not no additional specific training is needed. The standard Vibistem Inclinic protocol is a six-week protocol three times a week for 90 minutes. That is more than most outpatient therapists are doing with their chronic stroke survivors. So we do provide resources on um best practice for how to fill that time and how to make sure that we're getting the amount of reps that are required to make neuroplastic change. So we have lots of resources available to assist with treatment planning, uh, magnet home program tracking, um, different ways to provide those functional activities for patients. So we have resources, but that part is not, you know, not foreign to the therapist. We do provide training on how to use the SAPS computer that we provide to clinics, um, how to power it on, how to click, how many times to click per uh rep, how many reps we want to get, three to five hundred um per session. And then how to make sure that the pay the patients are correctly swiping their magnet so they get the benefit of the vagus nerve stimulation at home as well. And then we also use the Fugelmeyer assessment as our pre and post uh outcome measure. Um, so if there are therapists that haven't used that, we have some resources and refresher materials to help people feel comfortable with that. You know, we we trained the therapists on the system, but they already know how to do the therapy.

SPEAKER_00 30:29

Yes, yeah. In the um article and all the studies that have been done, I was looking at how success is being measured across the studies, and it all felt like very familiar. Like you said, there's the fugelmeyer, they were looking at the Berg Balance scale, functional communication, the fim, fatigue severity scale, modified Barthel. Like they were looking at wide varieties of what um the effect is. I'm curious, as you're working with therapists in the United States, you you mentioned the fugelmeyer. Is there any other ways that you um are tracking success with patients on a regular basis or just areas that you hope to see success in?

SPEAKER_01 31:16

Yeah, absolutely. So we do um recommend the fugelmeyer. Uh, it's helpful for insurance reimbursement and um achieving or um getting prior authorization if needed. But we have therapists that are doing all kinds of outcome measures in addition. Uh the fugelmeyer is a key measure, and patient-selected goals are obviously always very important. So we're going to be tracking success against those. We see therapists using uh range of motion, um, box and blocks, nine hole peg, grip strength, pinch strength, lots of different your your stroke impact scale, all of those things are being used regularly within the clinic setting uh to track to track progress. Um, some of those were also used in our uh our pivotal trial as well. And it's interesting because all of the results graphs look very similar and we saw improvement across the board in all of those measures, including the depression scales, which is sort of a whole nother area that is. Yeah, really interesting. Yeah. But my favorite, my favorite way to track practice or track progress or track success is um our vivistem victories. So we're internally we we like to talk about and share things that patients have have done that are really exciting to see. So we've seen um recently patients that have been able to go fishing for the first time since their stroke, throwing a ball with their kids or playing guitar or dancing with their spouse or holding their grandkids. And of course, those are the things that really matter. The patients don't really care if they got, well, some of them do. They'll say, I improved 12 points in my Fugel Meyer, and that's super exciting to them. But you know, at the end of the day, what's important is what can they do now? What function have that has returned that they're able to utilize within their day-to-day life to improve their well-being. And so that, you know, that part's my favorite. Like, what are what are the patients bragging about after the therapy is over?

SPEAKER_00 33:25

So emotional, especially thinking about chronic stroke, too, where there's probably a reality where the patient may have given up hope on finding the next level of improvement. And uh, I think as therapists, we know that there's almost always the possibility for improvement, but this having this paired device just really supercharges and opens that window. I want to go back just a second, ask one clarifying question about getting trained. Is do you get a certification when you're trained? Or uh what does the therapist have to basically show insurance to let them know that they're good to go to provide therapy?

SPEAKER_01 34:08

Yeah, no certification is required. Um, there's no additional education needed. It is sort of informal at this point. It's possible in the future that we're looking towards um something different, but it we don't have any additional requirements for therapists to be able to provide this. What we do have though is um some free CEU courses that uh are available for therapists that want to dig a little bit deeper and learn a little bit more about um, you know, the mechanisms and how to provide good quality therapy to different levels of function uh for patients. So we have um some a really good recorded webinar that um talks about what to do with your lower level patients and how to make sure that they're able to engage with therapy for those full sessions. So no certification, um, formal certification required, but there is support and training for therapists that would like to learn more and would like to make sure they have all the context. And then each area, um, each territory uh that is providing vivistem therapy will have a therapy development specialist, which is me for Indiana, Indianapolis, and um a territory manager, which uh my partner Jacob might be on the call. He and I work together to help connect uh patients, therapists, care providers together. So if you were to have somebody, a therapist, were to have somebody that they were interested in talking about Vivistem with, what we would do is have have you reach out to your local Vivistem therapy development specialist. Um, you can do that through me. You can do that on the website, um, and they would help connect you. But again, no formal certificate, but we have lots of resources for you.

SPEAKER_00 36:11

Um, I'll definitely have to connect with you to get those free courses too, because I I have a list on my website that I try to keep active of free courses, and I don't have those on there, but I will get those two people. Um I want to ask one more clinical question before I ask about cost and referral. Those questions are kind of piling up in my mind. But my last clinical question is I'm thinking about getting closer to discharge and maintenance. Um, from what you've said, it sounds like the protocol is six weeks. Is that right currently? Okay, so you do your six weeks, you still have an implanted device. What does maintenance look like for people? Do some people extend therapy? Kind of what happens after therapy for these patients?

SPEAKER_01 37:00

Yeah, so it's it's exciting because again, the research is ongoing for this and we we are still following what happens long term. What we know is that patients that have completed their therapy up to a year ago have maintained their progress from that that initial therapy stint that they got with the with Vivistem therapy. Patients can do a variety of different things. And at that point, we are, you know, that's up to the patient and the clinician. The therapy is billed the same way that it's billed otherwise. So there's no specific Vivistem code. You're billing therapeutic activity, therapeutic exercise, neural re ed, any of those things. And then the vivistem is a modality that you're using on top of that. So it can be, you can continue therapy, you can continue weekly, you can continue every other, you can have the patient come in in three months for check-ins, or do what they call the dental model and have them come in every six months or a year. And this is all, these are all things that ideally we'll continue to gather research on and inform best practice. But at this point, what's best for the patient, the clinician, and what's allowed with insurance is how we're we're sort of making those decisions. But the therapist can continue using the clicker with the SAPS, with the paired VNS during therapy when the patient is there. And the patient will be still be able to swipe the magnet and do the home, the home practice as well to continue to get the benefit of the paired vagus nerve stimulation during their functional home activities. And then the battery life is about five years with typical use. So at that point, uh again, several things can happen. It can stay put, it's not going to hurt anything if the patient is done using it and they've they've reached the goals that they'd like to reach. They can just forget that it's there and just leave it be. We can talk to help them connect with providers uh and talk about a battery exchange. So we might be able to um uh if patients are still getting benefit out of it, just replace the battery. And and who knows, we might have a next gen that is, you know, I don't know, we'll make your breakfast for you too. No, not really. Um and then, and then if you really are not liking it at the end, the option, of course, is always there to get it ex-planted, and that would be a patient surgeon discussion at that point. Newly added, we have a uh a long-term follow-up team that is able to and is dedicated to following up with patients long-term after the conclusion of their Vivistem therapy, with the goal that they can, of course, receive feedback on the Vivistem process, but also to be able to provide resources, help them get reconnected with therapy if needed, um, and to sort of help refine the long-term care process as well as make sure that those patients maintain a connection that is often lost in chronic stroke patients. So that connection to the medical system and medical care in regards to their stroke recovery.

SPEAKER_00 40:24

I'm really hopeful that the research that you all are gathering and seeing the success will just like kind of raise all votes in stroke rehab. Like right now, it feels like we have to fight so hard for the hours that we know patients need. So it makes me excited to just see more research coming out about the, or we know that we need high-intensity task-specific practice, but apparently we need more research. We need more advocacy to really get those hours. And I love just what you're putting out there and the model that you're um helping to make a reality for people. I want to ask about referral and cost. I want to preface that a little bit, kind of swinging back to the systematic review that we looked at at the beginning. That review was actually out of China and looking at uh what's happening globally. And they had multiple studies on the transcutaneous option. But so that is being studied, but it felt like the results were more variable. That hasn't been approved here in the United States by the FDA for post-stroke. So when you're talking about uh cost in referral, you're talking about the implantable option. So if someone I'm sitting in my little outpatient therapy office in Aurora, Nebraska, I get a chronic stroke patient on my caseload who I think would be a good fit. Walk me through the referral process. My question being like, should I go to the doctor first or should I go to you all first and you go to the doctor? Um, and then what kind of cost is that patient looking at? Um insurance coverage?

SPEAKER_01 42:13

Yeah. So um the our pathway is also can be varied. So um if you as a clinician know about Vivistim, but have no additional knowledge and haven't been in contact with one of us, the first thing you could do is contact if you know your contact information for your local Vivistem TDS, you can you can do that. Um, contact them and they can help you walk through that entire process. If you don't know your local Vivistem rep, you can go to the website and even just do the connect form, um, the get started form and and fill out a survey, and then your local rep will quickly reach out to you to get connected. Once you are ready to start uh the process and you feel comfortable with what the process is, the first step for a patient to become eligible to get this implant is an occupational therapy evaluation, including the Fugelmeyer. If they're already on caseload, it can have to be in a it doesn't have to be billed as an evaluist, it has to be in the in your documentation as you know the medical necessity blurb with the Fugelmeyer score and uh the impact on functional activities that the impairment is currently causing. If the patient does not is not already on caseload with a therapist, then we are able to help them. We as the Vivisdem TDSs and territory managers are able to help connect them with their provider to get a referral for therapy. But another thing that I like about this is because you know therapy is so integral to the whole process, it makes sense that it's also the first door that patients cross through. So that conversation between the patient and the therapist can occur to see, you know, is this really the right option for you, knowing that um, knowing everything that it entails. From the OT evaluation, that is submitted, the documentation is submitted to us, and then we can um, as well as to your EMRs, of course, so we can help with the prior authorization process and connect that patient with a surgeon in the area, a neurosurgeon in the area that is doing the implants for a surgical consult. The surgeon at that point then is the one that that determines, you know, surgical clearance, medical clearance. So as a as a therapist, you don't have to think through all of that part. All you have to do as a therapist, that first step is determine is this patient a um fall within the moderate to severe category of upper extremity impairment? And do they want to pursue VIPASTEM? So those are the only two things that you have to have to tease out. And then they go to the surgical consult. And then at that point, we hit what is the most variable timeline of the process, which is prior authorization, which I know we are all so familiar with and know and despise primarily. But we have a pass-through with Medicare, traditional Medicare. So no prior author prior authorization is needed for Medicare patients, traditional Medicare patients. We do require prior authorization for Medicaid patients, commercial plans, um, and Medicare replacement and advantage plans. We have a team called our market access team that assists with obtaining prior authorization and dealing with denials and appeals as they come through. And we have a pretty high success rate of getting the prior authorization approved. At that point, um, once we have approval, we would uh the patient would move through to scheduling surgery. They would have a um three to or two to four week wait between surgery and a follow-up appointment with their surgeon and when they start their therapy protocol. And then the TDS and territory manager are involved in those steps of the process as well for the patient and connecting the patient to their clinics and assisting with making sure scheduling is completed because again, it is a high frequency timeline for the treatment.

SPEAKER_00 46:56

Let me repeat this. Yeah, yes. Let me repeat this back to you. A patient with an ischemic stroke with moderate upper extremity dysfunction per the fugal mire, someone who uh wants to do uh a more intensive protocol, they have to be up for that part of it. And maybe you said this, but is there a point post-stroke that they have to be um three months out, six months out? Is there a timeline there that works for authorization typically?

SPEAKER_01 47:32

What we want to see is documented chronicity. So we want to see that they have they've been documented to be at the chronic stage. That's typically around six months. Um, but what they're looking for is sort of a slowdown of the progress or a plateau. And if if they're sort of at that, you know, four four to five month region and you think that they are in a chronic phase and have data and your outcome measures to support that, then we can move forward at that point.

SPEAKER_00 48:07

This has all been so helpful to understand all these details. I uh want to zoom us to the future a little bit. I had a question in the comments how long Vivistim has been around. It seems like it got approved in 2021. Is that right? Yes. Yeah. So we're still early in this world, in what's possible in the research. Exciting things are happening now. I'm curious with your like insider view on what's going on. What do you see in the future of this? Like more adoption, more yeah, I don't know. Yeah, what gets what gets you excited about the future here?

SPEAKER_01 48:55

Yeah, I mean, so much. And how exciting is it to truly be right the beginning of this? I feel like we're we've just opened like the prologue. So it's it's extremely exciting to be at this point. Um, and we're still learning how to optimize neuromodulation for recovery again, right at the beginning of that this process. So it, you know, it's it's just it's really it's really thrilling. There's more to understand about patient selection and timing and dosing um and how to get the best outcomes for stroke survivors. So I'm excited to see the research come in about that and see how to really refine best practice surrounding this. And, you know, the the biggest thing that I'm hopeful for is that we can really shift the conversation away from your recovery stops after six months. Because it there's just so much new data that's coming out, and it um it's supported by the American Stroke American Heart Associations that neuroplasticity is not time limited and it can continue throughout the lifespan. So I really am hopeful that in the future that is much more widely adopted and understood. Uh, because I think that that could have such a big impact on patient mental health and well-being in their recovery, knowing that there's no, you don't have to make all your gains in the first four to six months after therapy. Like, yes, work hard during that time and you're gonna um see uh increased speed of recovery, but it's not over after that. You can still, you can still make progress. So, yeah, that's I mean, that's hugely hopeful message for for stroke survivors and therapists. Um, I'm also really excited about the growing awareness about paired VNS therapy. Uh, more more therapists know about it, more physicians know about it. And then because of that, more stroke survivors are hearing about it. Um, so I'm excited about it just being more more widely available and and known about so that we can continue to reach more and more appropriate patients uh that could benefit from it. Yeah, I mean, I think I think we're really hopeful that we can have this paired VNS therapy for stroke rehab to move into a standard of care for chronic stroke survivors. So, you know, any any chronic ischemic stroke survivor that um is still looking for options is it's available to them. It's not just you know, based on where you're located, if that area is already using Vivistem, it's you know, standard of care. So everyone knows about it. So that would be the that's the dream, right? That everyone can have access. Any any everyone that is interested and is a good candidate would have access. Uh and it's just you know, it's exciting. And I think that it it also feels a little bit like we're bringing it back to this grounded space of the therapy is the foundation of recovery. The the work that you put into therapy is the foundation of the recovery, and the paired VNS is just there to help bolster and help really enhance the progress that you would get with the therapy and the work that you're already putting in. And so I think that just like you said earlier, raising all the boats in with first stroke rehab, we know good quality neuro rehab is the answer. When you add paired VNS, you get even more success.

SPEAKER_00 52:46

It feels to me like over the course of rehab, the history of rehab, it's taken us like a hundred years to kind of through trial and error learn like what works in rehab. Um, like we finally landed on like it's this high-intensity, task-specific practice, and you need to be in a certain state of neuromodulation. Like it took a long time to figure that out. And for the science to catch up to like, why is that working? Oh, it's working because of the vagus nerve. It's working because of these endorphins are getting released. And just as we're like finally understanding where the science is now developing so quickly that we're able to quickly supercharge those things. So this conversation just again brings me back to excitement about shining a light on the hard-earned knowledge that we've earned about the science of rehab and the new possibilities that technology is opening to supercharge it. And whether people work in stroke rehab or not, I hope this is helpful information just to think about motor learning, about uh your like the neuromodulation state that is most uh open to more to uh new learning. Those are my big takeaways from this conversation. Do you have any final thoughts that you would like to leave us on? We've touched on so many different both like uh logistics, but also big picture ideas about rehab. What do you want to leave us on today?

SPEAKER_01 54:22

Yeah, I mean, I think I think you you hit the nail on the head too. We got really we're standing on the shoulders of all the science that has been done up to this point. Vegas Fair Stimulation on its own is not new, but being able to really see the expanded view of what all it can do is is the exciting and and novel part. Um, and again, I think that as occupational therapists and rehab professionals in general, we play such a pivotal role in recovery. It's so nice to now have a way to just sort of turn it on turbo. We're able to to really use what we know to be good quality therapy and provide the brain with that enhanced space to be able to learn and make it even more effective. The the the the VNS itself is not the therapy, the therapy is the therapy. And it is just so exciting that we can have both to improve outcomes and that it's becoming more and more available to the patients that can benefit from it.

SPEAKER_00 55:35

Well, Sarah, this has been so fun. I love when practicing therapists make the leap into health tech and then share what they're learning with us on the ground. And I love this just trajectory that you've been on and that we really get to see that augmentation of rehab. Like we talk about that as a hypothetical a lot. And it's so fun to um see someone who's found that as their career and to see that really happening for such an important population um in our country and in our world. I'm so thankful to just be able to talk about the new science for stroke survivors. So thank you so much for being here today, for sharing, and just thank you for this conversation.

SPEAKER_01 56:16

Oh my gosh, thank you so much for having me. It has been a joy and it's always just so fun chatting with you.

SPEAKER_00 56:25

Thank you for joining us on the OT Potential podcast. To earn one hour of AOTA approved continuing education for your time today, you will need to sign in or sign up at OTPotential.com. Once you're in the OT Potential Club, you will find a five-question post-course quiz connected to this episode. When you pass the quiz with a score of 75% or higher, you will be able to download a PDF certificate that certifies your completion of this course. Okay, I want to thank you for joining us today, and we'll see you next time.