Good morning, everyone. Thank you so much for coming. We're so glad to have you here and really excited about this session that really focuses on different aspects of our practices to achieve that highest of excellence in our care for patients and also really what it takes to have a practice that's structured in that way. My name is Christy Hunt. I'm one of the pain physicians at Mayo Clinic in Jacksonville, Florida, so very close to here, but it's also my privilege to introduce our other speakers in this session, incredible giant leaders in the field. It's just such an honor to even be able to share a session with them, Dr. David Provenzano, who leads pain diagnostics and interventional care, and he's also the president of ASRA Pain Medicine, as well as a leader in our Advocacy and Policy Committee here at NANDS. He does a tremendous amount of work in the field of advocacy and policy, hundreds and hundreds of hours that he does so much on behalf of our field. Also Dr. Julie Pilitsis, professor and chair of neurosurgery at University of Arizona, and as you all know, past president of NANDS, just an incredible, just an incredible contributions to our field and to the society as well. So it's our pleasure to visit with you here today. We'll start by giving you our talks, then we'll have, we're privileged to have two wonderful abstracts at the end of our session, followed by some time for Q&A. I'm going to start us off with a conversation about social media documentation of neuromodulation, which in some ways is also a form of new media. What can we learn? And also thinking about what are reported patient experiences with neuromodulation on social media. We're going to try to differentiate patient reported experience from patient reported outcomes. The first category is something that we really rarely talk about, but it's actually what tends to impact the most in terms of patient reviews. What's documented on social media is actually the overall patient experience, even though patient reported outcomes are something that we do and should focus on, especially when we're talking about efficacy and safety of therapies. So today we're going to synthesize patient experiences reported on social media regarding neuromodulation specifically, also contrast, like I said, the patient reported experience from patient reported outcomes, and also recommend some specific strategies to provide true five star care to patients undergoing neuromodulation therapy as insights from some of these topics. So what do I mean by the patient experience? So patient reported outcome measures, we all know these, right? So these are tools to measure patient reported outcomes. These are everything that's reported in all of our studies, and what we're probably trying to record in our own clinic and experiences. These are standardized validated questionnaires completed by patients during the perioperative period and at certain predefined follow-up intervals to ascertain perceptions of the patient's health status, their perceived level of impairment, health-related quality of life, sleep, all of these things, and they're highly subjective. They allow outcomes to be measured from the patient's perspective and are the way we measure effectiveness and safety, particularly in our field. Patient reported experience measures are different. These are tools to examine the impact of the process of care on the patient's experience. This is something that I speak to docs can often be a source of frustration more than anything else because there are a lot of aspects of this that are outside of our direct control. These are things like the patient satisfaction surveys, right, Press Ganey, but they actually really impact your day-to-day practice in a lot of ways more than the patient reported outcomes, right? This is what's showing up on your Google reviews. You know, this is what, like I said, the surveys that go out are reported on. They can be relational. Do patients like their doctor? Did they feel listened to with their appointment? Or they can be functional, like has anybody ever been annoyed by, gosh, something like the hospital wasn't clean or maybe you're a part of a larger practice and their experience in GI has nothing to do with their experience in pain, and yet somehow that still seems to be linked or related. These are the patient reported experience measures. So patient reported outcomes and patient reported experience both drive research, QI, and economic evaluation. These are really closely tied, and we do a great job at conferences like NANDS at discussing patient reported outcomes, and at work, the discussion is often around the patient reported experience, right? I see a few of you kind of nodding in the audience, and this is what really drives some of our decisions when it comes to building a reputation in our communities and in our institutions. Choosing the right questionnaires and collection methods is critical, and there's a lot of different practical strategies that aren't necessarily the focus of our talk here, but you guys are all familiar with, right? So when it comes to how do you drive some of those positive scores on Google, things like that, there's a lot of strategies and tips and tools how to do that. But how we collect the patient reported experience measures is critical, just like collecting patient reported outcomes, and both kinds of assessments are critical for understanding the full impact of your overall perioperative and procedural care on patients. It matters. The patient's perception of their experience is actually part of what drives their overall experience of the therapy, especially in the world of neuromodulation. And you all know that your entire care team and infrastructure, even those outside of your care team, like the device company representative, play a part in that patient reported experience, again, especially in neuromodulation and especially in the aftercare experience. So what is the right care approach? What does the five-star approach look like? It's really this combination of patient reported outcomes, clinical research outcomes that are not always exactly the same as patient reported outcomes, but a part of it, and that patient feedback or the patient experience. So let's start by unpacking what we mean by this a little bit. There's not a lot in the literature about the patient experience, but actually I find this article that talks about colonoscopy and the patient experience actually mirrors a lot of what we do and a lot of our procedures that we do for patients in general. So the researchers in the study developed a conceptual model describing how patients experience a colonoscopy, which for a lot of patients can be daunting, can be uncomfortable, and the whole process surrounding the colonoscopy can cause a lot of angst. And they developed this heuristic that I think is a little helpful here. So they talked about different elements. So their overall health, their overall motivation for why they're getting this procedure done that they really don't want to get done, so what actually drives them to do it. Overall discomfort, information received, this kind of experience of care for the patient, and then their understanding of what's going on, or excuse me, their perception of being understood, felt, and listened to. And they talk about before, during, and after. And so when it comes to the patient reported outcome measures, a lot of it focuses on the during and then a lot on the after, and a lot of them are training our fellows or undergoing workshops to talk about how to do these procedures and neuromodulation specifically. We talk a lot about during, talk a lot about before, but sometimes there's this disconnect amongst the entire triad of before, during, and after. What's also really unique, oh, it's also very different from the colonoscopy in pain, of course, is this relationship with the physician, right, which is really important. And how do we maintain that caring relationship between patient and physician when there's a lot of touch points in your practice besides just you and the patient, right? Patients want to see their doctor, right, but it's just not possible for you to be everywhere all at once and all things to all people. So how do we use our care team and our resources effectively to drive that experience of a caring relationship? So this study considered how well the field's existing patient reported experience measures, so the existing experience measures that they use, accurately capture this entirety of the patient experience we just discussed. And they concluded from the study that they did that the significant gaps exist between what's commonly measured and the overall breadth of the patient experience. So they looked at, they looked at data from 13 different studies and they measured things like health, like I said, health motivations, what motivates the participants to go through the procedure, overall discomfort with the procedure itself, again, a lot of relevance to pain, but in this case, some of the bowel prep and discomfort with the procedure and immediately after. From the information standpoint, it was information about the procedure itself during the procedure and what they understood and afterward. And then, of course, that caring relationship they experienced overall and the patient's perception that they were heard, understood and listened to. So the fact that there was such a discordance in a field that actually pays a little bit more attention to patient reported experience measures than we do, a big disconnect between what the patient's overall experience actually is and how they measure it. So taking another example, there's actually very little on patient reported experience measures in chronic pain and neuromodulation. But there are some insights from acute regional anesthesia. So in this study, they looked at 243 patients undergoing elective upper extremity surgery and almost 95% reported being fully satisfied when they're under general and 68% reported being fully satisfied with the regional approach. And the main reason for dissatisfaction fell in regional anesthesia reported as having inefficient anesthesia prior to their surgery. And the discomfort of that kind of long lasting, you know, in this case, they were insensate after the surgery and felt uncomfortable. In a different study, a survey including over 50,000 adults didn't find this as one single factor that seemed to be associated with the rating of their anesthesiologist. So again, the analogy for us is with their doctor, but found that patients who received NSD sedation or regional gave more favorable responses than those who received general. So these two different studies have had very different outcomes, right? But a lot of it had to do with their overall experience of the procedure rather than long term outcomes, really the focuses of both of these studies. And another patient who underwent cesarean delivery, this is something that's being really closely studied and kind of the OB literature and regional prioritized effective pain management, communication, overall well being and their experience. And this is really what drove the patient's overall perception of that entire encounter and their care overall. So again, we have a dearth of this understanding a patient part of experiences in chronic pain. But you all are seeing it in your practices every day. And again, that's what's actually showing up on your Google reviews. And a strategy that I hear a lot of doctors talk about is how to drive more positive reviews, right? And there's strategies to do that, right? How would you rate your overall care? If it's anything less than a five, let's follow up on that, right? Or anything less than a four, let's follow up on that. But are there things that we can do more proactively than after the fact to try to craft that online reputation that will actually help to drive a better patient experience overall? Again, especially critically important in neuromodulation, when we are hope and expectations, these patients are doing better with these with this therapy for years. And my own practice when I'm seeing patients that come, you know, I'm at an institution where kind of like a funnel, right? And we disproportionately see a number of patients who are highly complex, or have had, you know, difficulties in the past. And the main difficulties that I hear patients say from their doctor, if they do have a current neuromodulation device in place, and are seeking my help with management, is that they didn't like or trust their pain physician, right? And you know, 99 times out of 100, when I hear these stories, and they kind of tell me their experience, it's rarely anything objectively wrong or faulty, right? But a lot of this is this experience and this perception drives them elsewhere, and drives them to then just not use their device, you know, dead battery, I changed out a first generation battery of a system recently, simply because they didn't feel comfortable going to their physician's office, right? Switched out the battery, they did very well with their therapy, right? They could have been doing better beyond that. So it's not something that we track or think about in the chronic pain literature the way that we do in some other fields. So pivoting a little bit to thinking about social media, and the question mark of are we really seeing more social media misinformation? So we all know, we all know what these things are, right? Twitter, X, YouTube, Facebook, and then Reddit specifically, has been looked at in different studies for a lot of different reasons, including the fact that this is de-identified, right? And patients are anonymous, might feel a bit more comfortable speaking up. And there have been a lot of different studies that have looked at things that patients talk about like oculoplastic surgery. And usually what it is, is provided just a lot of information that's often inaccurate and patients to kind of vent or seek support and community. Really not any kind of valid research, right? This is not where we want to go to, to have, say, we can have an objective understanding of patient outcomes or experience. But when patients leave your office, and you've talked with them, you've had, you know, you have wonderful literature, you've had a nice discussion with them about therapy that you're going to be undergoing, right? You had this relationship ongoing for weeks, months, maybe years or more, and you're moving forward. What do they do when they leave your office? They go on their phone, they look at Google, and what comes up? Often these Reddit posts and conversations, right? And they go in there, and that's what they're looking at. So we were curious to understand, when the patient leaves my office, and they're looking at their phone, what are they likely to find that we didn't talk about and proactively discuss? And what, how might that shape their perception of the therapy, maybe some of the fears that they might have, maybe things that I won't feel comfortable talking to me about, but that might actually impact overall their understanding of what to do. So this was, I found that questions like this were helpful for me when proactively trying to help set patient expectations. So we actually looked at RFA as well as spinal cord stimulation, so we developed this application programming interface wrapper, and identified and screened posts from Reddit users surrounding their experiences on both of these therapies. We looked at keyword searches, and then these are manually screened after they were collected by this program, and organized into a spreadsheet, which we analyzed, we looked at threads and comments, and the reviewed comments containing information we found to be relevant about the procedure, the overall tone of the comment, was it positive or negative, and then what did their intent seem to be? Was it giving advice? Was it venting? Was it seeking information? So I end up giving a big shout out to my research fellow here, who drove a lot of this. So for our initial screening, we looked at 155 posts, this is kind of where we did our data analysis, and it's really small here, but we were able to, we kind of divided it amongst the neutral, negative, and positive comments. And this is what we came up with overall, and again, I apologize for the small text, trying to get as big as we possibly could on the screen here. And there was a lot of, again, a lot of this is misinformation, right? So we're not kind of claiming that, oh, these are what the, you know, this is reflective of the majority of the patient experience or anything like that, but again, when patients leave your office, what are they reading and what are they finding out about, and how can we be proactive to discuss it? So things like device considerations, things that you probably expect, right? Differences between the brands, battery life, how did the battery feel? Was it waterproof, charging, remote control, reprogramming? So a lot of things that, a lot of conversations and discussions you're hopefully already having with your patients. What were their pain relief expectations? We saw a lot of discordance between what they felt during the trial and what they felt during the permanent. And I'll tell you, something that I've always emphasized to my patients when discussing neuromodulation, but what I really doubled down on after looking at this, at some of what patients, I knew patients would be reading about online was really doubling down on expectation management. I'm often counseling my patients, never expect the permanent to feel as good as the trial. And I said, that's for a number of reasons, but in my mind, it's because I know they want it to work, right? It's how placebo works. So I always counsel the patients, you'll never feel as good as you did with a trial for, there are a number of reasons for that. And so I want to tell the patients in my mind, maybe technically it's a 50% improvement, but what I tell them verbally is I want that trial to be a home run hit and you need to feel 100% confident. This is something that you want to move forward with. Now in reality, patients of course struggle, right? But I try to set that expectation early on and we talk a little bit about the difference between trial and permanent. What else are patients reading and talking about? So they're pre and post considerations. This was critical. And this is again, something that we often don't talk about and goes to the overall patient experience. What does it actually feel like to look with this? My favorite comment overall was, are you more likely to be prone to shark attack? Probably relevant to the patients in Florida. No idea why this was a concern. I think it had to do with like, is it going to send out this electrical signal to sharks? So I haven't gone so far as to say, let's do some shark talk, but I'll be prepared if it comes up. No, no. Other people have this question. You're not alone. But thinking about the aftercare, risk of adverse events, what it might look like from a wound healing standpoint. These were all relevant. Pain. And again, a lot of these conversations we're already having. Other considerations, how this would impact their overall day-to-day life and how it did impact their overall day-to-day life, inquiring about, you know, who should they trust in terms of their doctor. What was most interesting to me looking at all of these comments was there were only a couple that seemed totally left field, like, what is even happening? Most of them, even like the shark thing, it's kind of strange, but it was, hey, this is something they're fearful of. And it's probably not gonna be something they're going to ask me because they might be embarrassed about it. Right. But most of these comments and conversations were actually made sense. And there was sort of this genuine interaction between, you know, you know, patients and one another. Again, these people could be any individuals. Right. You know, these are not weirdos going on the Internet who are just making things up. That's totally possible. But at the same time, when the patient leaves my office, this is what they're looking at. And it comes across as highly credible. Right. So it was helpful to be able to look at what their overall experience looks like. So just to wrap things up, when we think about provision of five-star care and neuromodulation, it does not just come down to when the patient asks you, what should our plan be? What's going to be my modality of choice from a neuromodulation standpoint or other types of treatment? And what are my chances of getting better and feeling better? And all of these technical considerations that we do and should focus on in our conversation with patients. But what is their overall experience like? And that's often that missing link between patients doing well and patients performing extremely well. And again, it impacts their overall response to the therapy. We know that it does. So I like to think about I like to kind of have the hero sticker device in my mind of what is the patient's motivation? So in section one of every new consult, I kind of say a blurb about, hi, I'm Dr. Hunt. I know that Dr. Smith sent you here for this. I give a little blurb just to let them know I'm not coming in cold. But I say, set the agenda for me. What do you want to accomplish out of this visit? I don't necessarily ask, why are you here? Because that can go on a little bit of a time. I sort of treat it like a business meeting. And it tells me right away, why is this patient here? What are their expectations? And right away, if they're like, I want to fix my pain, their pain that's been going on for 20 years or 10 years, where they've had five surgeries, right away, we have an opportunity to reframe those expectations, right? And we want to say, I'm a physiatrist by background. So I'm super comfortable talking with patients about managing chronic conditions that we're not going to fix, right? So talk about, OK, we're going to try to manage your symptoms. And so right away from that very first encounter, where we're rarely jumping right to neuromodulation, we're kind of doing a little bit of an expectation setting. And patients actually do really well with those honest conversations. It's disappointing. But they do much better if we're not having the conversation about, you're not going to be fixed or perfect six months down the line, right? Want to make sure a lot, do they have that right information, which, again, there's a few different sources for that. But I want to make sure they hear it from my own lips or from my own team, the technical information, appropriate expectations about procedural discomfort, and being responsive to that, especially since most of these procedures are done with sedation and not general anesthesia, remembering what that patient experience was like between when they did or did not have general anesthesia, that perception of a caring relationship, which I want to extend to every single member of my team. I am fastidious about this. And this actually extends to people who are not my, who are not, you know, employees and part of our health care team, but something like the device company representative. That has to be a solid relationship, right? And the representative might come up to me and sort of want to have this friendly relationship. But I'm like, are you working well with my nurses? Are you showing up on time and educating the patient, right? That's much more important than, you know, than our personal relationship. But the entire team impacts that patient's overall perception of care. And then that patient's feeling of, do I feel heard, do I feel understood? I think a lot of us are a little bit afraid to have that conversation because we're afraid it could open up a big can of worms. But a little bit of time and a lot of strong, active listening goes a long way. So, those are kind of some of the takeaways from some of these studies that we've done. So, in conclusion, patient-reported outcome and experience measures are often missing in the analysis of what we do. We need more of that. We don't have to wait on studies. We can make changes today to impact what our practice looks like. The patient experience during the procedure matters. Social media might be a source of misinformation, but it's there. It's not going anywhere. And understanding what our patients are reading and hearing about is really important for the decisions that we make. And then patients might have a lot of different opinions, but you can be proactive in helping clear up some misperceptions in your practice from that first conversation that you have. Thank you all so much for your time. And I believe next we have Dr. Poganzano. Excellent talk. Thank you. I don't get asked about sharks in Pittsburgh. So I'm going to talk to you about when you get back to this five-star care, how do you want to optimize patient care? And I think one of the keys is putting the device in is the easiest of all endeavors, right? I mean, I don't mean it's easy, but the aftercare is extremely important. And how do you do that? One of the ways is optimizing programming. So I think the first thing we have to do is understand what the current programming is. So programming to optimize patient outcomes, the role of the MD and the patient. So Dr. Hunt gave an excellent presentation of what patients are looking for. And I think that Reddit survey really gives you some deep insight. So in today's talk, we'll explore patient perspectives on spinal cord stimulation, understand the role of programming and patient outcomes, analyze the influence of stimulation parameters on therapy effectiveness, and examine advancements in SCS technology and patient compliance. And we'll talk a little bit about remote monitoring, which hopefully will help us with this. Again, the reality is I don't mean to underplay the importance of doing a good job surgically, but you can do the best job surgically. If you don't optimize these patients in aftercare, your outcomes will not be what you want them to be. So what do the patients want? So I think if you go back and look, you can see why people kind of give up on their devices. This study was published in 2012. It was based on traditional spinal cord stimulation or paresthesia based. And this was at the time we didn't have closed loop technology, but we had something that was coming out like adaptive stimulation technology. And once you can look back, I always found this study interesting because you can go back and look, you figure how many hours a day are you awake, right? So you get up, you're up for, I don't know, sleep for eight hours hopefully. So you're up for 16. You can see on average, people were touching their remote control with no adaptive stim technology 18 times a day. That means they were touching their remote control at least once an hour to make adjustments in amplitude. Then with, sorry, that was with adaptive stimulation. Then when you saw without adaptive stimulation, it was 30 times. So that means people were touching their remote control at least two times an hour of awake time. So this means to me, like, I really would not want to be touching my remote control that much. That's a big problem. So when you look at compliance with therapy and reasons people may not continue to use therapy, you have to think about the burden of the therapy. So that is a challenge. I think it's really important as you go out there and you start to use SCS, understanding programming parameters. Many things we do have substantial impact. So this is a study just looking at pulse frequency and stimulation threshold and people with paresthesia-based systems. I think it gives us some insight why the higher frequency that we're utilizing often have to be either paresthesia reduced or sub-paresthesia. So this was looking at 15 patients with rechargeable controlled SCS. They had a fixed pulse width at 300 microseconds and they had a frequency anywhere between 40 to 1,200. So the pulse width was constant, but they changed the frequency. And what you can see here, they looked at three variables, perception threshold, therapeutic perception, and discomfort threshold. And what you can see is as people went to higher frequencies, all these amplitudes went down. So you can see that at higher frequencies, you had a much narrower window of what people were able to tolerate with regards to amplitude. They dropped. So as you went to higher frequencies, people did not like higher amplitudes. They actually found it uncomfortable. So the perception threshold, the therapeutic perception, and discomfort threshold all decreased. And you can see this here. When you look on the y-axis, you can see threshold current or the amplitude and you can see frequency. And frequency is increasing on the x-axis. And what you can see for all three of these lines, as you increase frequency up to 1,200, that perception threshold, therapeutic threshold, and pain threshold all decreased. So that means if you're going to use a higher frequency system, you're often going to have to use lower amplitudes. And you'll see on the next slides, you can see here, satisfaction on the right, quality of sensation on the left, and you can see pulse frequency on the y-axis of both these pictures. And what you can see is pulse frequency increases, that the quality of sensation goes down. People don't like it. And you can see that they're not satisfied with treatment as the frequency went up. Now, these are, again, paresthesia-based systems. So we show that as frequency increases, this is the conclusion of the authors, the patient's satisfaction with the perceived sensation decreases, suggesting that higher frequencies may need to be set at sub-threshold amplitude to achieve positive response. And we see this every day with the techniques we're using now. The other thing that I became very interested in is Dr. Hunt talked about how people, they get a great trial, but it's hard to get that outcome with a permanent implant. We know this. There was a good study from Allegheny General Hospital. The most common reason people were explanted is they could not achieve pain relief, even though they had pain relief during the trial. They could never even get pain relief during the implant. And so what I said was, is we have to go back and look at like what we're doing in our practice with programming and how close is the trial programming to permanent implant programming. And so we published this in Neuromodulation. Zef Leash was very helpful in this study. You can see the vertebral level and on both slides on the y-axis, and you can see the trial, and you can see the permanent implant on the x-axis. And so this was for a higher frequency system. And the question was, was how close was your bipole in your trial equivalent to the bipole in the permanent implant? Does the bipole give you any indication during the trial where it should be placed during the permanent implant? And what you can see is that the best bipole for permanent implant was either the same or adjacent to the best bipole during the trial for 82% of cases. So it was relatively close. So whatever you use for the bipole in the trial was relatively close for the bipole, at least being one adjacent level. And you can see for like the thoracic cases that it is between low T9, disk space of T9, T10, or upper T10. That's where all these bigger things consolidate. So there was some association. And the other thing is you always hear is that with higher frequency systems that there's a wash-in period. So we looked at our patients and said, what was the average time to people that got pain relief to get 50% pain relief during the trial? And it was on average 1.9 days, plus or minus 1.5 days. Why do I think this is important? Because unless we start publishing what we're doing in these studies to get these outcomes associated with these RCTs and someone provides the recipe of the programming and the aftercare, it becomes very hard to replicate these studies unless we understand that. And so what you can see here, this is amplitude and bipole programming changes. How many times during the trial did people actually have to change their bipole or they had to have a programming change by representative? Because this is all about labor. And you can see on average that most people had a amplitude change of two times and most people had to have a programming change of two times. So we can kind of map this out. I think we're moving on from paresthesia. You can see this from the, there are some people that like it, but you can see this even from the early birth studies that when you did, remember the birth study, you had to be trialed on traditional SCS or tonic, they would call it. And you can see what did people like. Of the patients, only 26% preferred tonic stimulation in that study, in the birth study. Now remember in the birth study, they equated pain relief as a responder is greater than or equal to 30% pain reduction. It wasn't the 50% that we traditionally used. But you can see why people liked the birth stimulation. It was mainly because of either lack of paresthesia or they felt there was better pain control. So as we look at the recent RCTs, you can see that for the most part, except for one, they're either paresthesia reduced or sub-paresthesia. And often these sub-paresthesia or paresthesia reduced technologies are using higher frequencies. And you can see the responder rates in the comparison arms and also on the closed loop arm, they're high. And I think the question is, is how do we reproduce these results of the RCTs in the real world? It's challenging. How can we do it? A little bit about open to closed loop. I talked to you about this. I think the middle road was adaptive stimulation. And you can see that that did help with people not touching the remote control as much, but they still had to touch it 18 times a day, which is at least once per hour. So closed loop, I think, is helping with that. And then the issue, and I have to give the researchers credit on this because I think we're getting some insight. You have patient perception, you have maximum, but the paresthesia-based system, like where is the pain relief? And I think we're getting some insight to that and some good studies on that. So if you look here, clinical meaningful dose ratio of closed loop SCS, you can see is that the calculation was about 40% above the ECAP threshold current. So I think this at least gives us some insight where we should be helping these patients with settings. So having that physiological data is helpful. So what happens after you implant a patient? Like how often do you have to interact with them? How often do they have to come to the office? How often does the clinical specialist have to help the patient? This is critical for us to know. And I really think that RCTs need to put this data now in the results section. So again, we went back and looked at our results on the higher frequency systems. And you can see when these are adjustments by the patients. So they either were therapy adjustments by the patients or amplitude adjustments by the patients with the light line being the amplitude adjustments and the dark line being therapy adjustments, which would be some type of programming. And you can see the time frame, trial, zero to three months, three to six months, six to nine months, 12 to 15 months, all the way up to 33 to 36 months. And what you can see is that the average patient, when you looked at adjustments post implant, in the first three months, they made about 8.6 adjustments. And by 33 to 36 months, they're making about 5.3 adjustments during that time frame. So still, the patients have to interact with these devices. It's not overly labor intensive, but they are interacting. And then the next thing is, how many times do patients have to come back to the office? And what you can see here, these are things, these are when our patients had to actually come back into the office. And again, you can read this in more detail in our publication on neuromodulation. But the device programming remained stable over three years. And the reality was, as you would expect, patients with greater pain would have had lower average quarterly programming rate. But you can see, you know, you look at three to six months, on average, people are coming back at least once. If you look at 15 to 18 months, people were coming back about once. So these patients, when you implant them, you have to expect they're coming back. They're going to come back for these evaluations and get adjustments. They're going to require something. The amplitude decreased with time. You can see this with their cervical and thoracic cases. So this is important to consider that you're probably going to see a declining amplitude with time. Again, the y-axis is program amplitude, and then most months post-implant. The recharge burden, we hear a lot about this. And so I think, can we do things with some systems to reduce recharge burden? Well, cycling is now in favor in many of these devices. And you can see, we went and looked at our data, and you can see that, on average, 36% of patients were on some type of cycling after 18 months, and most people were on postal settings of 14%. DTM uses a higher amount of energy. There's no doubt about that. So the question is, can you use DTM strategies to reduce energy? I think, too, I point out in the study, you know, again, can we reproduce the results of RCTs? They're hard sometimes, even prospective studies afterwards. And so you can see, patients did well, but they didn't clearly do as well as in the RCT. And you can see subjects experienced about a 50% mean reduction in overall pain from baseline at 3 months to 12 months. You can see that ODI improved, too. And again, this is on a DTM system, which now has cycling, 15 minutes on, 30 minutes off. So you could consider using this in a non-rechargeable system. However, if this was not adequate for the patient, you'd have to go back to traditional DTM, and you would wear out the battery quite quickly. So I think the reality is, would this last? And this is the longevity calculations. I think when we do all these calculations, you have to understand, like, how long would this last? So if you used a lower energy differential targeted multiplex stimulation, and your impedance was in the middle range, which it was for most patients, you get about six years. But again, that's if the patient stayed on that programming for the whole time, which I think we know is not always the case. Remote monitoring. I think this is important. We can't be seeing the patients all the time. I think that we have challenges when patients come to the office. I think as your neuromodulation practice gets bigger and bigger, like, they can take up a lot of exam rooms. And so it's important to help these patients. But how are you going to help them outside of the clinic? There was a nice publication on remote monitoring. And I think you can look at the metrics that you can collect. The patient can utilize, put in data, you can get remote monitoring, you get data from the system, and then the healthcare provider, also with the industry representative can work to help improve patient care. And I think this is important for our field. Clinical specialists. Obviously, they're extremely valuable. And I think Dr. Hunt talked about this, like clinical specialists, they interact with the patient, they're representative of what you're doing for care. And I think they often provide education, technical support for device management. They often train physicians on certain things. But you have to remember, there are conflicts of interest. And so how do we mitigate these? Because I value my clinical specialist, but I think having guidelines in place on how a clinical specialist works in your clinic is extremely important. And if you go to the AMA, they actually have published codes of ethics on industry representatives and clinical settings. Obviously, they have to focus on safe and quality of care. The qualifications of the individual have to be appropriately screened. Patient has to be informed that this is an industry representative. They have to understand that and it has to be announced. Obviously, they have to uphold patient privacy and confidentiality. Reps should not be running around showing the pictures of your cases or they have to be following the same rules of HIPAA like we do. And that's really important. And they have to abide by your policies that you set in your healthcare institution. And they have to not exceed the boundaries of training. So again, valuing clinical specialists, but having some guidelines in your office to make sure it's appropriate. So in conclusion, I gave you just some brief things to think about. First thing is that we really have to understand programming. If we are physicians utilizing this technology, the most important thing is the delivery of electricity as a therapeutic option to treat pain. Well, we have to understand how to dose that therapeutic option. It's complicated. I think all of us spending time to read and learn more about it will help patients. Number two, I think we also have to look at what's actually happening post-implant so we can understand how the recipe worked. And if we, just like the Toyota production model, if you understand the process and the process is working, then you continue with it. If the process is done the same time and part of the process is broken, you identify it and fix it. But if no one ever tells you the process of how often these patients were programmed, what their amplitudes were, how often the clinical specialists talked to them, then it's very hard to reproduce these results. We need to understand that. There's no doubt that closed loop systems are giving us physiological information that will help with regards to programming and help us provide insight into patient outcomes and getting better patient outcomes. Compliance is critical. Dr. Hunt provided data on what patients care about, educate them on that. And I think we have to focus on improving therapy personalization and, again, defining the recipe. What were the maps for programming parameters, interactions, and this should be published in all RCTs. Thank you. Good morning. So, first, before I get started, I wanted to ask who in the audience does their own permanent implants? Okay. And, you know, I think when we're looking at this, you know, I'm a neurosurgeon by training, but I think all of these things apply, albeit a little bit differently when you're thinking about, you know, performing your implants or if you're thinking about doing that in the future, just things to consider. Thank you. I was pressing on that. Anyway, so, you know, oftentimes when you're thinking about your practice, you know, and you're new and starting your practice or transitioning to practices, you know, you're kind of just thrown in and thinking about, okay, how can I get up my patient volumes and moving forward and what do I need to do that? And, you know, I would argue that instead you should take a pause and think about what it is that you're trying to build other than patient volume. And, you know, like anything you're doing, whether it's starting your own private practice or your ASC or doing research, kind of coming up with your own mission, vision, and values around this. And ultimately, I think that helps you get to the goal of having a practice that you can be proud of with good outcomes that patients really value. So how do you do this? You know, when you're thinking about a mission statement, you want to think about what you do, how you do it, and why you do it. A mission statement is generally something that is, you know, what you do every day as opposed to a vision statement where you say, okay, I want to be the leading implanter or the most famous, you know, implanter in Florida. You have to think about where you're going with this. So in terms of an example of a mission statement, you know, one example is the mission of ABC Pain Group is to provide patient-centric pain care with best-in-class technology and outcomes. Pretty reasonable mission statement. And then you want to think about the values that you bring to that too. And here are some values that, you know, I think about when I think about a practice, and this may resonate with many of you, you know, you want to be empathetic and put your patient's needs first and foremost. You want to use the evidence to do best practices. You want the patient to be empowered and be able to make decisions appropriately and be the center of that patient care team. And we have a lot of patients to see and a lot of people that need us, and you want this to be efficient. So how do you do this? And, you know, I wanted to go through some strategies for developing a practice with you all. And, you know, I think this really is dependent on having a business plan. You have to understand your area and what you bring to the table. Identify what you're willing and able to do and what you're not able to do. And identify who needs to be on your team. So first, understand your area. Right now, I am in Tucson, Arizona, which is very similar to, you know, my life in Albany, New York. I always say the two places are remarkably similar, though I know that seems crazy if you haven't lived in both of them. But I have a nice wide catchment area. Phoenix is far enough away that they're on their own market. And it's kind of a self-contained entity of 1.5 million people or so. I've had the opportunities to build practices other places, too. So I started my career in Worcester, Massachusetts, which is 40 miles outside Boston. That's a really different entity. And, you know, I also practiced in South Florida. Really different entity. So you have to think about where you are because the same things, you know, the same general values, mission, and vision will work. But how you go about those become a little bit differently. So what I'm most comfortable with, you know, as establishing a surgical practice is on the left side of the screen, which is a Spoken Hub model. I'm an implanter for my area. So a lot of people will send their trials to me to implant. There are a number of permanent implanters in my area as well. And so oftentimes, you know, that's by pain specialists, anesthesiologists, or PM&R docs. And what they'll send me is kind of the challenging cases. And, you know, I really enjoy that. And that's been a way to build an effective practice. Many of you that do your own implants have enough business that you're generating internally or from your partners in order to generate that. So, you know, while you might be not the Spoken Hub externally, you are internally to your practice. I found myself during my time in Florida a little bit on the situation on the right-hand side. So, you know, lots of private practice docs, lots of different people doing things. And, you know, that was a challenging environment to build a practice because you had to get in there. And, you know, even as somebody that has built a practice a number of places here, you know, I had to start seeing pain way before they were ready for implant. And, you know, I also do deep brain stimulation. So I had to start seeing Parkinson's patients that weren't necessarily DBS candidates in order to grow that practice. So I think there's different strategies that you need to use based on where you are. So you have to understand what it is you bring to the table. Right now, you know, I'm at a tertiary care facility. So, you know, another group of patients that come see me are patients that aren't safe to be done in an ASC, you know, or ASA3s, three and a half, four and above. So I often get referrals for those patients. But, you know, in talking to some of the docs in town that do their own implants, you know, I think what they're trying to think about is it's really important for them to, you know, as they're establishing their practices of permanent implants, to do this very safely and to pick the most optimized patients so that they can develop that moving forward. So you have to understand where you are, what you're trying to do, and what you bring to the table. Then I think you have to set expectations about your practice. Who in the audience does pain pumps? Okay, so fewer than that do permanent implants. And why is that? Because we all know the infrastructure that has to go around patients with pain pumps. You know, there's, I always joke that the greatest way to make a functional neurosurgery practice non-elective is to have a pump practice, right? Because we know they'll come in, in the middle of the night, and you need the infrastructure to deal with that. Who gives prescriptions for meds? And, you know, then what kind of meds are you doing? Do you have to do, you know, drug screening? Do the patients have to have contracts with you? How are you going to work with that? Who's going to follow up your SES patients? As Dr. Provenzano mentioned, you know, as you get busier and busier, you could take up all your exam rooms, having people reprogrammed and doing this, and you have to figure out what that relationship is with the rep moving forward. And I concur that you have to develop that relationship with your clinical specialist and say what your expectations are. For, you know, my clinical specialist, I'm much happier to work with them if they are really transparent with the patients about what's expected in the trial. And, you know, I think Dr. Hunt's point was really good. Even when I do my own, like, buried trials, so PERC to PERM, people still, and like, I haven't moved the lead, right? Because it's a buried trial. People still say, you know, the trial was so much better than the PERM. And that's because, you know, I think of the placebo effect. And I also try to explain to patients that, you know, it's pretty easy to do something for five days. When you're asking a device to do something for a lifetime, it's a different can of worms. So develop relationships to amplify your message. So, you know, in my practice, I don't give pain prescriptions. I work with the pain, the people in town in order to do that. And I have a policy there. And because I am really clear on that, the pain doctors are happy to do that with me because they have pain people under contract. There's not any back and forth with the patients about this because they know that this is a policy up front. And when you have people that will say the same thing that you're saying to people over time, that's really helpful where, you know, they know what your parameters are with going back to work or they know what you're expecting people to do. Or, you know, I have a whole rigmarole I do for my pump people on keeping them flat and hydrating and caffeine. And it's one thing for me to know what that is. But patients have to hear that from multiple places in order to have that resonate. So if I say the same thing over and over, everybody else in my office is going to my clinical specialists are my referring docs are. And that makes for the patients not to get so much misinformation from their own doctors. There's plenty of misinformation out there as you know, probably that they're getting on Reddit and other things. So, you know, this is our opportunity to shape the amount of information that people are getting. I often have lunch and learns where I invite patients to learn about these devices without being in an exam room. And then they can learn from others that have had this done. So I like this because then you have kind of a Reddit forum, but you know who's responding. So they can hear things that we as physicians never would have thought about from other patients in terms of what they're doing. And make sure in your office you have things that people are going to want to look at that are going to amplify your message. So using metrics, this is really important. You know, we actually get in the habit when we finish neurosurgery residency because in order to get board certified, we have to do our first 10 cases and we have to send those into the board. They review it to make sure we're on the right track. And then we have to send 100 cases that get reviewed by a panel of neurosurgeons. And then we have to get quizzed on those cases. So, you know, we're already in the habit of doing this. And, you know, even if you're not, if you don't have to do this, I think it's really important to follow your data, especially like probably throughout your career, but especially as a young physician so that you can see what your outcomes really are. Now, I had a great setup during my time in Albany where I had a small army of people that would help me track outcomes. So I saw all my SES patients before at six weeks, at three months, at six months, at one year. Without a small army of people, sometimes this can be really difficult to gather all of that data. And it's really time consuming. And, you know, fortunately, unfortunately, my office, I think, was really inefficient there. So the patients had a lot of time to wait and they would do these tests while they were waiting. Now, this just, I don't have the bandwidth. I don't have the people in order to do all of those things. So what are key things that you need to look at? You know, I think you need 30 and 90 day complication rates at a minimum. I think if you're going to ask one question, I don't think it should be NRS. You know, if I had to pick one question, it would be your global impression of change. Like how much better are you? And, you know, I think then you have to go back and look at that objectively because you don't want your metric of what you do to be your last case and judge which of your patients are responding. And, you know, I think there is a whole bunch of literature and advice that you can get out at measuring patient satisfaction because what you don't want is, you know, oftentimes when you go online and you review anything, it's people that love you or they hate you as opposed to, you know, things that are really constructive that could help move things forward. And metrics change. Your policy changes, what you do changes. And, you know, I think it's important to, you know, the people that are involved change. So you have to evaluate these metrics oftentimes based on the team you have, who's interacting with the patients. You know, make sure that you're optimizing your billing and coding as well, because if you don't do that, this isn't sustainable. And you want to make sure that with all the changes that occur, that you're, you know, doing all the right things there. I did want to talk a little bit more about the value of a database because I think that this really is the way to provide outstanding care. And whatever this looks like for you needs to needs to be built into your practice. And, you know, even if you haven't done this for years and you don't know where to start, start tomorrow and, you know, try to find even those small 30, 90 day complications as well as global impressions of change as a starting point. Here are things that we've tracked in our database and we built it into our standard of care routine so that, you know, even for patients that we were, we consented people because we were going to publish on this. But if this is a, you know, quality metric, you don't need to think about IRB and other things. Well, you need to think about it, but, you know, it often does that a quality initiative is usually outside the purview of the IRB, as is any of your standard of care routine. So, you know, through this, we were able to create, you know, one of the largest prospective SES databases in the world where we have about 2000 patient visits. As I went to different places, I tried to make this more user friendly and less dependent on a large team of patients. So now we have these in iPads so that people don't have to enter it into the computer themselves. And I think anything that can get it into your medical record is important. There's a couple of apps that are, you know, up and coming where patients can do this at home. And, you know, I think the big issues that come up with there are HIPAA. But, you know, most of the things that are going through Amazon Web Services right now are indeed HIPAA compliant. And then you want to look for trends among your patients. I know some of the device companies have certain trends that they're following in the patients, but they may be collecting data a little bit differently than you want to collect your data. So doing this yourself is really important. And again, you know, while I'm giving you very basic things that I think everybody can incorporate into their practice with certain things, having a holistic outcome is the best thing. And I think that's why Global Impression of Change, if I had to pick something, is more important because without you doing anything, it incorporates both pain, the patient's activity, and, you know, kind of their feelings about their pain. So what else can we do with all this stuff? And where do we ultimately go? I think it's essential to collect this data. And I think registries are essential so that we can move the technology forward so that we don't have to have all those visits in the office. And, you know, AI can automatically program people as to where they're going. I think this will not only allow us a better opportunity for patient selection and to predict who we're going to have good outcomes on, but I think it can also direct people to the right therapy eventually. And, you know, there's a lot of promise in this regard. By grouping people into chronic pain or failed back surgery syndrome, you know, we all know that, or I guess PSPS, people aren't going to respond the exact same way if they've had a one-level discectomy versus five, you know, multi-level fusions. And we need to figure out how to incorporate radiomics into this as well. And then ultimately, how do we do this? Well, you know, it's not going to be, you know, clinical research coordinators in your office, you know, doing this as one-offs to get the amount of data that we need. I do think it's important that we have a web-based platform and that we have a graphical user interface that both satisfies the patient's needs as well as the provider's needs. And there are multiple ways to do this, and important that all our societies get involved with similar. So, in conclusion, I think in order to have a practice that you are proud of and that your patients benefit from, it's important to build that practice on your mission and your values. You know, think about what you can incorporate to track your outcomes and your patient results. And ultimately, learn from your patients, do things that affect the patients and what is it that they talk about on that Reddit platform, and how do you provide better care? Thanks so much for your attention. Thank you, Dr. Palitsas. So now we're going to do two abstracts. And the first abstract is by Dr. Jason Pope, who is the CEO of Evolve Restorative Center in California. He'll be showing the ECAP study premiere, Real World IDE Study. This study actually got the Oral Abstract Award, so we congratulate him for that. And come on up, Dr. Pope. Good morning, afternoon. You know, I was in the audience listening to all these great opinions regarding building a spinal cord stimulation practice and a neuromodulation practice, and I'm sitting there and I'm thinking, how does leveraging a physiologic closed-loop controlled therapy play a part in that? And I have six minutes to describe this potentially, and I have two minutes for questions. So I'll start with what I noticed in the previous presentations. First is, there is a growing concern that we can't predict success of spinal cord stimulation long-term with a brief application during a trial, and that's been published in a lot of different spheres. Sam Aldabi did a lot of work with that. Interestingly enough, a different abstract that I'm presenting tomorrow describes that that may not actually be the case. That if you leverage a biometrically-driven objective physiologic measure to describe what you're doing to the spinal cord, not from the device side, but from a dosing perspective, you can actually achieve predictable, sustainable outcomes from trial to 36 months. And I've done a lot of work looking at that story. So when we think about spinal cord stimulation, this concept of trialing with placebo influence and with paradigms that may be tried during trial and not emulated at more of the sustainable electrical application to the patient, I can say that when you employ a physiologic closed-loop controlled therapy, just like you can in continuous glucose monitoring, that revolutionized the management of diabetes. Why would we not think that if we do the same thing where we can measure an activation level of the spinal cord, titrate towards success based on a dose? And part of what I'm going to share with you today is maybe appreciating what dose that could be, looking at all the data that we've leveraged, looking at this physiologic closed-loop controlled therapy tool. So this is the data premier for this. I'm presenting on behalf of the 22 principal investigators. And so I want to thank them for the opportunity to do this. I want to thank NANS for the opportunity to be here, and I appreciate the award. So thank you for all that. But we know the EVOKE study. The EVOKE study, I think, was a pivotal study in our space. It's a 36-month outcome, which is the longest we've ever had. It's the only double-blinded study that we have within our space looking at neuromodulation. When we think about it being prospective, multicenter, double-blinded, self-selected, crossover, comparative study, there's not many holes that you can poke into the study design and the long-term outcomes that we saw in that based on where it's been published. So we've had 11 publications looking at subgroup analysis, appreciating the holistic response that Julie described. I, too, believe that pain intensity application or assessment is not the way that I think we holistically describe patients. I've done a lot of work with the PROMIS-29. I saw the PROMIS-29 slide within the registry application that she was suggesting. I think that is a better holistic approach looking at patients to qualify their experience because we know pain intensity by itself does not do a good job. So built on the shoulders of this ECAP study, which is another IDE that was done looking at this physiologic closely controlled therapy, it gave us an opportunity to describe people holistically, and that's also something that we talk about within the impact guidelines. So built on the shoulders of the EVOKE study, we were able to pull out some salient information and, again, to remind you, this is measurement of neural activation in vivo, in humans, in the real world. I think that in and of itself is supremely impactful, and when we're talking about optimizing your neuromodulation practice for the few implanters that we have in the room, I think when we all reach to use spinal cord stimulation, we want to reach for something that we think is going to work. We don't want to manage the patient where we give them an application during the trial and we have challenges associated with maintaining the expectation of pain relief. And I can tell you, and we're going to show this, physiologic closely controlled therapy gives you an opportunity to predict outcome and durability with much more fidelity than we've ever had in our space before. And we can see that when we look at composite scores, looking at a holistic outcome, we see significant cumulative responders based on an MCID, which is a minimal clinically important difference, with an 82% reduction of pain. And we can describe this strategy of application of electricity to the spinal cord as an ECAP or a dose relative to an ECAP. So if we say that neural activation with a threshold is an EVOKE compound action potential threshold, you can essentially normalize the dose, which is individual for each patient and appreciating that the dose response curve is different for everybody, the sensitivities are different for everybody, but you can normalize that by saying how far you are above that person's individual ECAP threshold. And we define that as a dose ratio. So for example, an ECAP as a one dose, if we're describing this as 1.5 or a 1.5 dose, then you're 50% above the ECAP threshold. Really simple. It gives us an opportunity to normalize how we're applying the spinal cord to create guidance on how to achieve outcomes across a diverse patient population. Interestingly enough, when we looked at all of those 11 publications that we had before, all of them were on back and leg. So the purpose of this study was to look at a real world study population, looking at different groups. And so this was prospective multicenter single arm real world application to collect neurophysiologic data in the real world and to look at outcomes and maybe dosing associated with those outcomes. And so this is a large study. We had 220 people in this cohort. And again, to describe what I think Julie hinted towards also, this holistic treatment response is something that I think every neuromodulation study should apply in the future. So when we look at a meaningful clinically important difference, we want to choose instruments that have domains that look at different variables or features within the patient's sphere of influence. And so we have the PROMIS-29 is commonly employed. There's seven domains. And we can then essentially tabulate the meaningful clinically important difference across each of those domains, summate them, and come up with the depth or the improvement in meaningful clinical improvement for that patient. And I think that's an easy way to then standardize and approach multiple domains within an instrument. So for example, for this person, when you summate all of the MCI-Ds across the seven domains of the PROMIS-29, we get a score. And so we can use that score to describe the depth of treatment influence comparative to the normative population. And that's the benefit. And so essentially, when we looked at the ECAP study population, we said, well, how is this representative of the people that present pain and spine practices in the United States? And so we did a large retrospective study of about 19,000 people in a database looking at baseline PROMIS-29 scoring. And we said, how comparative is the ECAP population to that population? And we can see it's pretty dang close. You can see also that in the ECAP study, they were a little bit worse off, as you would expect, because they're further along in their treatment. They have now an opportunity to get a neuromodulation device. The data that we're comparing them to were people that entered into pain and spine practices. But it's very representative of the cohort of the people that you manage within your patients, within your clinics. And when we talk about maximal analgesic efficacy, and we're talking about dosing based on neurophysiologic data and creating this biometrically driven application of electricity, we see in the full cohort, we have a depth of treatment success across PROMIS-29 domains of nearly 12, which is super impressive. And when we talk about the opportunity to use composite scoring, I think it's interesting that when we look at each individual PROMIS-29 instrument within the domains within the instrument, we have meaningful clinical important difference, which we'll see in a moment, across all the domains of at least one, very commonly two. So we've not seen this in our space before. And when we see across those other different patient populations, like post-surgical pain, non-surgical low back, diabetic peripheral neuropathy, CRPS, upper limb, we see very clearly that the depth of improvement across a holistic tool is consistent with a large depth of nearly 12. When we think about how this is done in the office versus how it's done at home, we see that it is exactly the same. There's some nuance that I'm not going to go into because I have 13 seconds left. But I would say that this is a game-changing revolutionary strategy, and I would implore you to think about it. This slide builds, so I'm just going to build it for us really quickly. But what we see is that across the different populations, across the different domains to describe a holistic response, we see that the number of MCIDs, which is a clinically relevant difference, trying to describe holistic response is most often almost double. So let's put that into context real quick. So for, say we have a 30% improvement rate as a numerical rating scale, which is an MCID, say that it's 30%, double that is 60. Say that we have an ODI that has an MCID of 15, double that is 30. So there are crosswalks associated with the PROMIS-29 with all these other relative instruments. But I can tell you with a lot of confidence that describing this holistically as a space is the right thing to do. And number two, obviously measuring a neural target and titration towards a dose is much better than a black box strategy of applying electricity based on an algorithm and not knowing where you're going and how you got there. And I think previous to physiologic closed-loop controlled therapy, that's exactly what we see. So in conclusion, I will say that in this real-world cohort, we can achieve maximal analgesic efficacy across the populations that you see on the slide here that you serve in your patients with a high degree of predictability and tolerability. And I appreciate the opportunity. Hopefully this fits into optimizing your neuromodulation practice. And have a great NANCE. Thank you. So I think it is very helpful to see data and like Dr. Pope talked about electrophysiological data help us improve outcomes. So now Dr. Thomas White is going to talk about cervical lead placement with DTM, the Procura study. Good morning. I'm Dr. Thomas White, and I have the privilege of presenting to you Differential Target Multiplex Spinal Cord Stimulation, or DTMSCS, specifically cervical lead placement for upper limb pain, and this is the ProCura study. First of all, I just want to give a big thank you to my medical mentor, Dr. Ricardo Viejo. Without him, none of this would be possible, and this study was a catalyst for my private practice in Houston, Texas, and very thankful for him and this opportunity. So we all have a prevalent amount of patients in our private practices or practices in general that have persistent cervical radiculopathy, despite optimized medication management, a well-placed cervical epidural steroid injection, and unfortunately these patients sometimes proceed to an ACDF, a multi-level ACDF, and they have persistent cervical radiculopathy that can be debilitating. There's limited published evidence on SCS lead placement in particular, as well as programming algorithms for upper limb pain treatment, and recently there have been multiple, specifically three, randomized control trials in regards to evaluating differential target multiplex, or DTMSCS, specifically regarding non-surgical back pain. All three RCTs were recently published. All three RCTs show responder rates of 80% or greater. So it was our intention to expand on the indications of non-surgical back pain with this particular waveform and therapy to see how this works for a prevalent problem such as cervical radiculopathy. Recently, the BRCA study demonstrated safety and effectiveness of DTMSCS with cervical lead placement for upper limb pain through 12 months, as the BRCA study was published in Neuromodulation Journal three months ago. In regards to the objective for today, I also wanted to provide comments on particularly the lead placement, electronic configurations, and where we're actually stimulating with DTM to achieve these outcomes. So the study was a post-market, prospective, multi-center cohort study involving 11 sites across the United States, and there were follow-ups at one, three, six, and 12 months, and the objective was to evaluate DTMSCS for upper limb pain and its efficacy. The primary endpoint was the responder rate defined as at least a 50% improvement in upper limb pain at the three-month time point, and there are multiple secondary objectives including VAS reduction, PDI, PGIC, et cetera, and you can see in the right side there the inclusion and exclusion criteria. Most notably, those who were included were those patients that had an on-label indication for SCS, and those who were excluded were those with posterior element surgery as well as mechanical spine instability. So the results. On the left, you see the upper limb pain responder rate, and you can see at three months, 93.5% of patients had at least a 50% improvement in their upper limb pain. 93.5%. When I saw these numbers, I was astonished. However, it was consistent with my personal experience enrolling patients into this study and since then as well, and you can see that this responder rate not only is significant, but it's sustained up to 12 months with an 86 responder rate. The VAS reduction to the right in the middle there, you see the starting VAS on average at 7.25 with a sharp reduction to the low ones and that flat line sustaining that substantial relief out to the 12-month time point with a 79.7% reduction in average baseline VAS at 12 months. So we're talking about responder rates in the 90s with VAS reduction at 80% at 12 months. On the right side, you can see that 100% of patients were satisfied or very satisfied with DTM-SCS, which makes sense when you have responder rates and VAS reductions with those numbers. So what exactly is DTM? So I want to break it up between two central concepts. Differential target. So this waveform, basically you have two different electrode configurations stimulating two different targets simultaneously. So say for instance on that picture to the right, those two blue bi-poles you can see are targeting, say for instance, the C23 target. And to the left there, you see that it's utilizing a low frequency of 50 hertz. So you have one target being stimulated with a low frequency that we call base at 50 hertz, while simultaneously another target, say C34, is being stimulated with a high frequency. Now this particular target is being targeted with three waveforms that we call primes 1, 2, and 3. And each prime has a frequency of 300 hertz. So you have one target being targeted at 50 hertz, while a second target is being targeted simultaneously with three 300 hertz waveforms. So differential target multiplexed, meaning that there's a combination of high frequency and low frequency. The reason for that is that it's based off the pre-clinical work that Dr. Viejo did evaluating glial cells. Glial cells outnumber neurons in spinal cord tissue 12 to 1, and they were largely ignored historically because they do not propagate in action potential like a neuron does. So scientists stimulated these glial cells with electricity. They did nothing, and they were ignored for decades. And recently it was discovered that these glial cells respond to an electrical stimulus, not electrically, but with a chemical response. So these cells were evaluated, and we looked at, in chronic pain, glial cells have chemicals, say for instance, an example that there's 20 chemicals that are increased, 10 chemicals that are decreased. What combination of frequencies and waveforms would best regulate, modulate these chemicals and normalize chemical homeostasis? It was determined that a low frequency and high frequency combination better achieved chemical homeostasis in glial cells when compared to a low frequency alone or a high frequency alone, which is the pre-clinical basis for a differential target multiplexed spinal cord stimulation, stimulating two different targets simultaneously with a blend of high and low frequency at the same time. So the programming during the trial, there are three DTM groups that the subjects could rotate through to see which group worked best for them. Each group involved four charged balanced multiplexed signals with pulse widths between 100 and 200 microseconds. And we just discussed that the base, one group at 50 hertz, and the primes, two, three, and four, each at 300 hertz, each stimulating two different targets. And we were looking to see which programs worked best for which patients because each program had different electrode configurations stimulating different targets, whether it was base at C23, base at C34, primes at C45, and so on. As far as the implant of the device, the implant was performed in the same location to the best of the implanter's ability as well as the programming was reflective of the trial. So we tried to mimic the implant as identical to the trial as best of our ability. And the lead placement itself, we're currently compiling the specifics of the electrode configurations in regards to the responses. Anecdotally, I found very good success with using a base at the C23 space with primes at C34. So that electrode configuration gave results consistent with this study for me personally. But we do look forward to getting the specifics in regards to which locations worked best for these patients. In conclusion, the PROCURE study demonstrated clinical efficacy, safety for DTM for upper limb pain in subjects with an on-label indication. In this study, DTM therapy resulted in significant and sustained upper limb pain relief with a responder rate of 86% and VAS scores of less than two at 12 months. And this study indicates that DTM SCS with cervical lead placement is an effective treatment for chronic intractable upper limb pain. Thank you. All right, I think we have, you know, about seven minutes left in the session for any Q&A for our speakers, and also if our poster presenters are still around, you're also welcome to come up, too. So we'll take any questions that folks might have from a Q&A standpoint. I don't know if we have a mic, but you can always just project, yeah, please. Can we get a mic for you guys in the back? Up here. I'll bring it down here. I think the question was asking the presenter if he could comment on whether a sensing device makes more sense in the cervical spine. Yes. Thank you. Thank you for the good question. It wasn't clear that a sensing was not involved with this study, and it would very much benefit from a sensing electrode just because of the nature of the cervical epidural space. With constant neck motion, you know, rotation, extension, flexion, and it also being a smaller epidural space. So I think that would really benefit the therapy, that technology combined with that therapy would maintain that therapeutic window. But this was not involving a closed loop system. So thank you for that question. One question that I have for Dr. Pulitsis is I think it's very difficult for a lot of people to effectively get patient-reported outcomes in their practice. A real issue is responder rate, and we all know that the people who are most likely to respond are probably going to be those who aren't doing as well. So do you have any tips or recommendations? I think you kind of mentioned people coming for in-person follow-up, and obviously you've got your chance right there. But especially when you're using tools like RedCap or patient surveys in their home. Any tips or thoughts on how to improve responder rate across the board for these outcomes? Yeah, you know, I think that's a tough problem. And, again, you know, I think it's going to be like any survey where you get, you know, the people that are going to score you a one or a five on a five-point scale. So really happy or really unhappy. But I'm a big believer that, you know, the patients are really amenable to being trained on what's expected of them with this therapy. So I think if you set up out front that, you know, hey, we're going to do this, we're going to do your patient-reported outcomes at this point, you know, at six months, at 12 months, and thereafter yearly, I think that's one helpful thing. You know, I think that we all get reminders on our phones. And, you know, in so many ways medicine is, you know, behind the times in a lot of different things. But, you know, being able to kind of automate that response. And, again, you know, there's a number of apps, you know, that I'm not sure are ready for prime time but are being used where, you know, you can have your patients, you know, ping your patients to have those responses and other things. So I think, you know, automating it, preparing the patients for it are the best strategies. It's always going to be an issue, but I think it will get better. Absolutely. I think it's also challenging because that patient's response and sensation can be influenced by a lot of things. Stressors in their life. Did they help their buddy move the day before? You know, are they particularly sleep-deprived? Did they actually, when they're talking about their pain and you sort of did an implant for, like, I don't know, CRPS, but they, you know, sort of broke their, you know, like, I don't know, broke their hand or something a couple days before. They're going to kind of mix the whole pain experience and sleep together. So I think there's a lot of exciting opportunities to sort of improve how we think about this in our field. I think that's a great point. And, you know, kind of building off the work you did, you know, I think we ask that question and we say, how are you doing? And, you know, then they start talking about, you know, the fact that they're having a bad day. And, you know, and then you have to, like, reframe a conversation to say, like, I get it, today's a bad day, but how have you been in general? Are there more bad days than good days? And it may be an opportunity, you know, even to figure out, and again, you know, have to be really careful doing these things. But how do you get a patient group to say, what's the most effective way to ask you this question? Because, you know, I think we have a lot of trouble as physicians doing this, so it would be great to, like, capitalize on their input as to how we could do that. That's what our group is trying to do right now, I think, is how you get accurate responses and how do you get people to respond. Dr. Provenzano, I wonder if you would mind thinking about, when we think about automation, AI, remote monitoring, how do you think that those sort of, do you think that there's hope that that sort of data could better inform our practice and try to achieve that five-star care and also sort of overcome some of these challenges with getting patient-reported outcomes? I think we all want to know in our practice, how can we do better? How can we improve that experience? Do you think there's any opportunities there? Yeah, I think there's definitely some opportunities with that technology. I think, first of all, hopefully you'll get longer-term responses and better responses. The other thing is often what patients tell you in the office may not be their experience at home. And so I think when you start to do remote monitoring, you may get a clearer picture of actually what's happening. Hopefully also it would lead to better response times from us and the clinical specialists with regards to patients that are struggling. And I think, I mean, I'm sure we've all had, I know I've had them. You have patients come back to your office and you say, how are you doing? And they're struggling and they've had the device off for three months. So hopefully you can capture that earlier and interact. So I'm very excited about remote monitoring. I think it can be helpful. I think AI, as Dr. Pulitzer showed, I want to read those two papers actually. I think that there's definitely advantages to having large cohorts of data and understanding where there are signals that you can utilize. So I think AI helps with that. And I also think AI can help with patient training too. Yeah, I had a patient come into my office who had a device put in 2016, had a battery swap in 21, and they came in. Again, it's a different practice. A new patient to me and said, oh, you know, when I had this battery, when my battery swapped out, I had a totally different experience. I lost my pain capture. I was like, oh, that's kind of where we're talking. He's like, hey, you know, the other funny thing is that all of a sudden they couldn't have the MRI. I was like, you know, so I was like, is it the same device? Well, no, it was the same device and everything. So I took a look at his X-ray. You could see one of the contacts wasn't all the way into the battery. So obviously we went down that road and switched the whole thing out. So all kinds of things can affect a patient's response to therapy, and you can't always. You think in the age of all these tools, like why was the company not alerting or, you know, did we not do an impedance check at the time? So even with all the automation that we have, we still have limitations and problems. So I can't think our speed. Oh, go ahead. Actually, a question for you, Dr. Hahn. So if you looked at the Reddit study and you had to say, like, four things that you'd try to address now in a patient that is considering SCS, based on that data, what would be the four things? That's a great question. So I do think of it along the continuum of care. Number one and probably the single most important is expectation management. Are the patient's expectations aligned with what I think is realistic? Is that kind of aligned with what I think is achievable? I think that's the single most important thing. You can think about all four things, but if expectation management is not realistic and aligned and you've not spent your time involved in that conversation, there's a high likelihood that things are not going to be aligned in terms of success or what the patient's looking for. Number two, it would definitely be setting clear expectations in preparation for the trial to the PERM implant process. All of us have things in our practice set up where we can kind of educate the patients and we feel like in five different times we tell them, here's what our expectations are, here's what we're going to be doing in the trial, here's how long to wait for the permanent implant, and there still kind of become follow-up questions. And that's okay. But being responsive about that and kind of having a clear plan and good information in place for what they should get with the trial. You both spoke about how it's so important that the paradigms that our clinical specialists use in the trial may not be mimicked during the implant. And I'm actually frank about that and what I talk with the patients about. And I emphasize, you know, look, we have a limited window of time where we can try to get this information. So there's good reasons for that. But it's really important that patients have that good expectation and feeling. Number three, I think it's that very acute period after implant, even up to two weeks, we're trying to really minimize that chance for any acute adverse events. Like we've talked about, I tell my fellows this, nothing that you do after the implant is going to work as well as what you did perioperatively and during that surgery in terms of reducing the chance of infection or complication. So strict surgical technique. We just recently had infection control guidelines published. That's important. But after the implant, making sure that their activity restrictions are adhered to, making sure that they're not messing with that wound, all different strategies for how to do that. I started having them wear a binder, not necessarily because I know that it's going to be seroma, that's going to reduce seroma. Maybe it does, maybe it doesn't, but it keeps it protected so that when they're riding home in the car and they're not rubbing the thing against their, not rubbing their wound against the seeds or their clothing, things like that. And then I think for number four, it would probably just be that long-term aftercare attention, because I think that, you know, our hope is that patients always do well with the therapy long-term and they do great for a long time. And both our speakers presented excellent studies on, you know, outcomes, you know, through 12 months, things seem to look pretty good. In the real world, we always know that those things can shift and change. And so how do we have a plan in place, whether it's through patient-reported outcomes or whether it's through regular follow-up visits in the practice, that can pay attention to how these patients are doing over time, making sure that your clinical specialist knows, please bother me. If the patient's not doing well, please let me know. I know that you don't want to bother me. I know that you want me to think everything's great and hunky-dory, but let's work together. And if patient's not doing well, have your system and infrastructure in place to check on that patient and do some troubleshooting, because the longer they go without doing well with the therapy, the harder it's going to be to recapture. I think that's what the data shows us.

patient care

neuromodulation

patient-reported outcomes

social media influence

Spinal Cord Stimulation

closed-loop systems

programming alignment

quality improvement

data analytics

AI in healthcare

differential target multiplexed SCS

pain management

innovative technologies