All right. Well, welcome back, everybody, this afternoon. So this morning, we focused more on a musculoskeletal topic, and we focused on the shoulder. This afternoon, we're going to kind of switch gears and take more of like a neuro approach. So kicking us off this afternoon is Dr. Kramer. He's actually going to give two lectures back to back. So the first one, he's going to be talking about intrathecal baclofen for spasticity management. And then the second one, he's going to be talking about Parkinson's disease. So Dr. Kramer graduated from the Chicago College of Osteopathic Medicine, and then completed his transitional internship at the Chicago Osteopathic Hospital, and then went on to do his physical medicine and rehabilitation residency at the Rehabilitation Institute of Chicago, also known as the Shirley Ryan Ability Lab. So he is board certified in physical medicine and rehabilitation, with a subspecialty certification in both pain medicine and spinal cord injury medicine. And he's currently practicing interventional pain management in Orlando, Florida. So please join me in welcoming Dr. Kramer. Thank you. I appreciate the opportunity to speak. We're going to talk a lot about spasticity. And the title of the talk in the brochure focuses a little bit more on stroke, but we'll cover a broad area. So I certainly want to give you an idea of how this can be utilized in the patients with spasticity with a variety of different diagnostic conditions. This is a Florida honeybee. I couldn't resist taking that photo. So this is our agenda. We'll discuss understanding severe spasticity and also discuss treatment options, benefits, and risks associated with intrathecal therapy, and of course, address any questions you might have. So I'll try to review what spasticity is. We know that it's a form of muscle overactivity occurring when there's a disruption in the normal pathways of muscle stretch reflex and muscle tone regulation. And this can result from, of course, spinal cord injury, multiple sclerosis, cerebral palsy, cerebral vascular accidents, and of course, traumatic brain injuries. And it's defined, or we typically see severe spasticity, tight, stiff muscles making movement very difficult or uncontrollable. And also, these muscle spasms can be quite painful. In fact, many times, it isn't the functional limitations that patients report when we see them, but it's actually the pain that's associated with the spasticity. And these are diagrams of what we typically would see, the flexion of the wrist and the fingers, the equanovirus condition, hip adductor spasticity, and also the deformities that can occur in the fingers and the hands. And again, manifested by increased muscle tone, overactive reflexes, and it can be demonstrated by involuntary movements, what we might describe as clonus. In some cases, it can be continuous. And also, what we see in some patients isn't necessarily the clonus or the hyperactivity, but actually just the tightness of the muscles that make passive range of motion so difficult. And again, it can be associated with pain. And obviously, it's going to result in limitations in function and interfering with daily activities. So the biggest concerns that we always see are, is it going to interfere with their ability to dress or bathe themselves? Abnormal posture can result in difficulty with wheelchair positioning, and also difficulty positioning in the bed. And then, of course, the long-term consequences of hyperactivity of the muscles, causing fixed contractures and deformities. And that can cause bone and joint deformities. But the biggest issue that we see with this may be the manifestation of pressure ulcerations being developed. And of course, decreased quality of life for the patient. But I think we also have to be very cognizant of its impact on how spasticity affects the caregiver. And that's something we always need to be aware of when we're talking to our patients and asking questions. So how common is spasticity? Well, in the cerebral origin, when we look at stroke patients, we know that there are potentially over 6 million individuals suffering a stroke each year. And up to 7% living with severe spasticity. And then, when you look at individuals with cerebral palsy, we also understand that there are over 700,000 individuals living with cerebral palsy. And more than 50% are living with severe spasticity. And these are patients we see in our clinics coming in. Other areas that we're looking at are spinal cord injury. And multiple sclerosis being one of them. And MS, over 400,000 individuals in the United States. And over 30% living with severe spasticity. Spinal cord injury, over 200,000 in the United States. And more than 30% estimated to have, and when we speak of spasticity, it's severe spasticity that we're referring to. Most patients will have some degree of spasticity. But that may be a good thing. In some cases, having spasticity may be beneficial for them to be able to walk or to actually maintain muscle bulk and tone. So spasticity can be managed through a variety of different treatments. And certainly, our focus is going to be improving the relaxation of these muscles to improve their activities in daily living, transferring, positioning, feeding and dressing, sitting more comfortably, and also experiencing less spasticity-related pain. And again, as we mentioned, relieving caregiver burden. But I think it's also important to understand that spasticity, in and of itself, is not something that necessarily has to be treated. So if a person is utilizing spasticity for ambulation, if they're using it for maintaining muscle bulk, then that's something that we don't necessarily want to eliminate. We've had patients who have completed an intrathecal baclofen trial, and it resulted in a significant reduction of tone. The pump was implanted. And the next thing you know, they're not able to walk where they were able to walk before. So these are things that we have to take into consideration. Do we want to reduce or eliminate spasticity? In some cases, we may not. Or through intrathecal therapy, it allows us a little bit more adjustment to the therapeutic treatment. So what are some of the options? Rehabilitation is, of course, our core treatment approach for people with spasticity. Oral medications usually are second-line treatment. And then a variety of injection therapies. And then, of course, intrathecal therapy, and then even neurosurgical procedures. So rehabilitation, fairly straightforward. Physical therapy to improve strength, range of motion. Occupational therapy may be involved in splinting activities. And of course, the full complement of speech therapy and psychological support as well in case management. Oral medications, reversible, non-invasive. But they are a systemic treatment with potential side effects. In some patients, it works very well. I've had patients who were referred because of increased spasticity in their arms and legs. And when you question them, you find that they really did not have an adequate trial of oral antispasmodic agents. And I think it's important to realize that a lot of the patients that we're seeing in the acute care setting, and even in the rehabilitation setting, may not have manifested significant spasticity until much later. So when we look at some of the stroke studies that we've done, we understand that stroke spasticity could occur many weeks, months down the road. And it may be that the spasticity is developing after they've completed inpatient rehabilitation, after they've completed outpatient rehabilitation. And now, they might even be discharged, or I'll see you in six months. Or they might come under the care of their primary care physician. I've had patients who have presented to our office, and the only antispasmodic agent that they've been on has been Robaxin or Flexeril, when they haven't even been considered for medications such as Baclofen or Tizanidine. So a lot of times when we're seeing these patients, we want to certainly make sure that they have tried oral medications, and also that they've been taken to the most effective dose, assuming no side effects. And obviously, oral medication can be difficult to dose. And it's going to take some time. When patients come in to see us, we'll start them on a low dose, and then we'll slowly titrate up. But that titration could occur over a period of time. So it is a little bit more time consuming in that regard. The biggest issue we see with any of the antispasmodic agents, the most common of which are Baclofen and Tizanidine, and even Valium to some extent, is the drowsiness, the hypotonia, sometimes even causing too loose of muscle tone, lethargy, altered mental status. And that's especially seen in our elderly population. So these are medications that work fairly effectively. But the side effects of these medications may really limit their use. So many of the patients that we move forward with intrathecal therapy have tried oral medications, but have found the side effects to be too overwhelming. So Baclofen being the most common, usually starting dose for this medication is 5 to 10 milligrams, 2 to 3 times a day. And then you would slowly titrate up. My maximum dose of Baclofen would be 120 milligrams a day in divided doses. I've even seen some patients higher than that. Valium, anywhere from 2 to 5 milligrams, 2 to 3 times a day. And then Dantrolene is a good medication, typically utilized in the pediatric population. Laboratory studies need to be taken on those if we're going to continue patients on those. And the other thing with Dantrolene is it works on the sarcoplasmic reticulum. So it doesn't just focus on muscle hyperreflexia or muscle tone, it's going to weaken all the muscles. So if there's muscles that you don't want to weaken, you're going to potentially weaken those as well. The limited utility in many of the patients that I see, I don't know if I have any patients on Dantrolene. And then Tizanidine or Xanaflex, I say relatively recent. When I was in training in the 90s, this was a medication. So we were placing, when we couldn't adequately control spasticity with oral Baclofen or Valium, we were putting on a catapress patch. And we were very pleased with the effect that it had. This ultimately led to the development of Tizanidine. And I was involved in the clinical studies that led to it being approved for this type of spasticity. So excellent medication, alpha-2 blocker, and anywhere from dose range from two milligrams three times a day, upwards of a maximum dose of 32 milligrams a day. And so all these medications can be helpful. And I've had patients who have presented because of poor spasticity, tried therapy, tried Botox, and then when you question them, you find that they really did not have an adequate trial of these medications. So we'll start to increase the dose. We'll see if it works. I've had patients who were considering, I'm excited, we're gonna get you an intrathecal pump for your spasticity. And next thing you know, I increased their Baclofen and their Tizanidine. Doc, this is great, my hand opens up more, I can walk better, I'm happy, I don't need to do anything more. So occasionally we find that these medications can really make a difference without any side effects. Injection therapies, we had a great lecture with Mark Clafter earlier. So Botox, of course, being the most popular one, I think it's important also to realize that Phenol is still out there. And I am utilizing Phenol for some of my patients. I'm using it in conjunction with Botox. In fact, Mark Clafter and I share a patient where he's doing Botox and I'm doing Phenol for a patient who had a stroke. Relatively young man is his 50s. I actually did a Baclofen trial on him and he did fantastic. I was excited about offering this therapy to him and he said, I don't really want anything implanted in my body. I'll take the Botox, I'll take the Phenol. And we see this gentleman every three months and it's been going on for at least eight years now and he's just doing great. So you have to be mindful. Now, Mark may have alluded to, but in our conversations, the issues with Botox, it can be quite expensive and some insurances aren't gonna cover it. And so those are issues you get into with Botox, ordering it, charging for it, billing it. And also Botox typically lasts anywhere from three to four months. So you're repeatedly performing the Botox injections. And also it tends to be more effective for the focal spasticity, the finger flexor spasticity, the elbow flexion spasticity, maybe the toe flexor spasticity or ankle plantar flexion spasticity. So when we see a patient who has severe spasticity involving the upper and lower limbs or both lower extremities, many times the amount of botulism neurotoxin that we can provide is not gonna be able to be effective for that type of spasticity. Now again, Phenol, similar type of situation. Phenol is quite inexpensive. You can get a big jug of that for pennies practically. We get it through a compounding pharmacy and it's injected through motor stimulation. Not expensive, very effective. It can be uncomfortable and painful, but we certainly have patients who we are treating with Phenol as well. In fact, we have quite a few patients who are actually doing both, intrathecal therapy and Botox and or Phenol. And they seem very content with that treatment approach because sometimes you're improving overall spasticity maybe in the legs but not adequately improving in the arms. So again, we'll utilize the Botox as an adjunct to what we're treating the patient with with intrathecal therapy. This is a neurosurgical procedure, dorsal rhizotomy. When I was in training, we were able to see this procedure perform mainly for young pediatric patients where they would surgically cut the sensory nerve root to try to reduce this stimulation for the patient. Not reversible, used predominantly for lower extremity spasticity. So some of the children with spina bifida, cerebral palsy, they were utilizing this as an adjunct. And of course, combined with rather aggressive physical therapy. Typically, there are patients who are ambulatory, spastic, diplegia, no significant abnormal movement patterns, so just tightness. And then, of course, no visual impairments. And of course, they have to be engaged in a very aggressive post-operative program after the dorsal rhizotomy is completed. Orthopedic surgery would be considered a last resort but we do get calls. I had a colleague of mine contact me regarding a patient with severe muscle spasticity with severe contractures. And we certainly recognize that the Botox for the traumatic brain injury patient, full arm and leg spasticity, very tight. And this had been going on for a while that just giving an intrathecal back-lipid dose or trying to give them oral medications is not gonna be helpful. Sometimes what we were doing in the past, I haven't done it too often, but I might do a nerve block to see how much of the muscle tightness or range of motion restrictions due to spasticity versus a fixed contracture. But if you see a fixed contracture or even significant tone that's causing, potentially causing a fixed contracture, then orthopedic surgery, the tendon releases, the tendon lengthening procedures can be effective and may be very well indicated for some patient population. So we always have to keep this in mind. It's not treating the spasticity but it's treating the secondary effects. And this also could be combined. We've had cases in which patients have had Botox first and then underwent a tendon lengthening procedure combined to reduce the spasticity post-operativity to allow for more comfort when they're undergoing some casting that may occur. So we still continue to treat the spasticity even after orthopedic procedures. This is not a cure for these patients. So intrathecal back-lipid therapy. So this is delivering the liquid form directly to the intrathecal space, delivering it into the spinal fluid. So it requires less medication. Average dosing of intrathecal baclofen, anywhere from 25 micrograms a day for some of the patients with MS who seem to be very sensitive to intrathecal baclofen, all the way up to potentially 2,000 micrograms per day. It may help minimize some of the side effects that we see with oral medication. That seems to be the case for us when we have patients who did not do very well with their oral medications. Then we were able to find that they did very well with intrathecal therapy. So side effects seem to be minimized. So who do we consider? Obviously, it's going to be patients with these diagnoses. But the biggest issue is have they failed all of the treatments? So typically, they've been through the physical therapy, the occupational therapy. We've tried their oral medications. Baclofen, Doxanidine, maybe Valium, if we think it's indicated with an understanding of the potential risk of the dependency on that substance and its abuse potential. And then, you know, are these the patients that we might consider with botulism neurotoxin? In some cases, that would be the direction we would go. In other cases, we may realize that the amount of asbestos is such that botulism neurotoxin or phenol may not necessarily be indicated. The other thing we have to consider for these patients, and this is really an important aspect of this, because occasionally I'll see patients who are referred for intrathecal therapy and they appear to be a good candidate, but we have to ask ourselves, is this a good surgical candidate? So, for the stroke patients, many of the stroke patients that we see have other underlying medical conditions, so they may be on anticoagulant therapy. Is it safe to discontinue the Eloquist or the Coumadin for doing a trial and then doing an implant? Some of these patients have other medical conditions like diabetes, so we know that diabetic patients, if they're poorly controlled, if their hemoglobin A1C is greater than eight, we're not going to consider a surgical intervention because we know that their incision is not going to heal or has the potential for poor healing, and so we want to make sure their diabetes is under control. Other areas that we consider now are the patient size, and there's a couple reasons for that. One is the surgical risk of having a wound dehiscence because a lot of adipose tissue, so if a person has a BMI greater than 40, we do not usually consider implanting an intrathecal pump for these patients. The other issue is when you're placing the pump into the body, you have to attach it to something, and so if you have someone who's very large, there's really not much you can attach it to except maybe some fibrous tissue into the adipose tissue, so that predisposes that pump to movement, flipping, which could then cause catheter entanglement and then actual discontinuation of therapy. So, we try to make sure that they're of adequate size, BMI under 40, hemoglobin A1C under eight, and also in a coagulant issues, cardiac clearance, medical clearance would need to be obtained. So, we try to get this up front before we consider moving forward with the initial trial. Other issues are cigarette smoking. Is the patient willing to give up cigarettes? And it's sometimes amazing to see patients who come into your office with a stroke and they're still smoking cigarettes, and you have a conversation with them, well, we don't want to do this because it increases your risk of poor wound healing, and you're going to need to stop smoking, I can't give up my cigarettes. So, anyway, but these are issues that we address as to who should we consider. So, it goes beyond just a failure of spasticity treatments. So, if we decide that they're a great candidate, we're really excited about this, then we go ahead and schedule them for an intrathecal baclofen trial. So, what we do in our facility is we have them come in, an IV is placed, we're going to monitor them in our outpatient surgical center for anywhere from six to eight hours typically, could be longer if needed, but they'll be the first case of the day, bring them back into the back room. Some patients will have IV sedation, some people no sedation at all. I'll perform a spinal tap, I'll then take a small amount of spinal fluid out, and then I inject typically 50 micrograms of baclofen intrathecally through a single bolus trial. Actually, we'll do what's called a barbitage procedure, where I inject and pull it out a little CFS, CSF, trying to mix it all up, and then I inject, then I take the CSF that I took out, flush the needle, pull the needle out, a Band-Aid's placed. So, no needles are placed, nothing's left in but the medication. There are some facilities that will do continuous intrathecal catheter trials, and a study that we participated in that was done in some facilities, not typically performed too much in the United States, but it can be done, and that would, of course, require, in most cases, a hospital stay, where you might do some titration of dosages over time, but usually it's not indicated. What we're really looking for in that intrathecal trial is, can we reduce tone, and are there any potential side effects that might limit the use of the intrathecal therapy? Potential problems with the drug, as well as, of course, the procedure, is headaches, and, of course, the intrathecal baclofen can have a variety of different effects on patients. We'll, I will inject at the lumbar area, but it will slowly move up throughout and disperse throughout the spinal fluid, even affecting the central nervous system. So, I had some patients who became very somnolent, which is always nice when you're in a surgical center, because you can monitor their pulse and their oxygenation and their blood pressure. It doesn't happen very often. Most people tolerate it very well, but that is a risk. We've had patients who have experienced significant amounts of nausea and vomiting, another reason to have them in a surgical center. You can give them a little Zofran, help them out for that period of time. Headaches are a potential risk, because you're performing a spinal puncture. We usually have them rest supine for two hours to reduce the risk of a spinal headache, trying to allow for CSF normalization, as we know there's going to be some spinal fluid leakage through that puncture site. But most people seem to do pretty well. Two hours, we'll get them up, we'll start doing range of motion testing, see if they're ambulatory. We'll have them doing some walking to see if it's effective. And you have to be mindful that it can cause overly loose muscles. I've had patients who walked in the door with their walker and couldn't walk out the door later in the day, because the Baclofen was so effective that it actually took away their spasms completely. And that was really what they were utilizing to emulate. So, these are things that you see, which is helpful, because by knowing what their response is to a bolus dose, you know when you're implanting the pump where to set the dosage range. So, it kind of gives you an idea. If they had a really robust response, then maybe we'll start at 25 micrograms a day through a continuous infusion. So, usually the response is anywhere from 30 to 60 minutes. Typically, we see the maximum response at about the two to four hour mark. And we're going to monitor these patients over about six to eight hours to see how they do. And then we'll go ahead and compare. Sometimes physical therapists are engaged. In most cases, I'm doing range of motion testing. I'm checking muscle stretch reflexes. I'm asking them how they feel. How did they do with a transfer? How did they do with standing? So, those are the things that we're asking them. And then there are some cases in which this doesn't seem to cause much benefit. Some of the traumatic brain injured patients, the cerebral palsy patients, can be a bit resistant to this treatment at the 50 microgram dose. And some patients are already on oral baclofen, sometimes at a very high dose. I think there's a development of a tolerance to that. We don't have patients wean down or stop their baclofen prior to these trials. So, sometimes we might have somebody who's on 120 milligrams of oral baclofen, obviously not working. We're doing a trial, and the 50 microgram dose just doesn't do it. So, we'll have them come back several days later and perform a 100 microgram dose. And that typically will start to see some changes. So, you have to be mindful of that. And a repeat dose could be performed. And then, of course, we want to see a positive response before we consider implanting a pump. So, we want to see at least a reduction in muscle stretch reflexes, improve range of motion, have their perception of it. And we've recognized that that test dose may not meet their goals of walking better or of transferring better. It's really just the beginning. We recognize that once we identify that they're not going to have any major side effects with this medication, that then once the pump is implanted, we can increase the dose and we can do a lot of other changes over time. So, the test dose is really just to get a general feel and also allow the patient to kind of experience a little bit of what they might with the implant. So, the one thing you have to be mindful, we want to make sure that there's no infections. If a patient has a pressure ulceration, we're not going to do the procedure. We don't want to potentially risk any bacterial spread into the epidural or into tickle space, of course, allergic issues. And then, of course, this issue of body size. For the most part, I've not seen any concerns of a body size being too small, even though that obviously is a concern. The pumps come in 20 and 40 milliliter sizes. So, in the pediatric patient, we've had, you know, very small children have the pumps implanted into the abdomen and do just fine. So, in most cases, size is not a major concern, but it would be a concern for the implant to making to determine where you're going to place that pump. So, it's really quite amazing. I tell you, when you look, you think of miracles in medicine, this is one that really is astounding to me, but also astounding to many of the patients because this is a patient who's had potentially many years of increased tone and spasticity. I'll do a single maclofen dose and then the now their passive range of motions improve, the stretch reflexes are gone. I had a patient, we just did a stroke patient, hemiplegic spasticity, the whole treatment approach was provided to him, Botox, oral medications. And we did the trial and he, his wife took a video of him actually at home after he left the facility. We let him go at about seven hour mark. Later, a couple hours later, he demonstrated that she had a video, she showed me that he was able to go to squat because he was ambulatory. And it was actually, and he had not been able to do that before. So, you know, it's amazing to hear these different stories from patients that really make you excited. This is a patient who had had a stroke about five years before and never even had anyone discuss intrathecal therapy with them before. And I find that to be rather common that some of these therapies are not offered. And it might be because, again, when they left the acute rehab facility, outpatient centers, the spasticity is developing over time and maybe they're not in contact with physicians at that point that have a good understanding of this therapy, or maybe they're in a region that really doesn't have a good support staff to manage these types of pumps. This is a nice pictorial of the pump. So, you can see when we're placing the needle, it's going to go right into the intrathecal space, usually entering it at L3-4, and then the pump being placed either into the buttock area, the flank, or into the abdominal region. So, that's a nice diagram of the placement of the yellow catheter into the spine. The actual positioning of the catheter varies. If a person only has lower extremity spasticity, then typically we'll keep the catheter tip in the lower, usually around T10 or T11. We try not to place the catheter right around T12 or L1 because it would be right on the conus. And if we, in some cases, we're going to add marcaine to their pump, we'll occasionally add marcaine or other medications, and that might impact their bladder function. So, typically we'll move the catheter up to a T10 or T11 for lower extremities. And for people with upper extremity spasticity, the traumatic brain injury patient, cerebral palsy, the stroke patient with upper and lower limb spasticity, we may try to move that catheter up to as high as T2. In the study we did on stroke patients, we actually looked at the catheter tip location. And there is some evidence through CSF flow studies that the higher you get the catheter up, the more chance you're going to have a better flow of that baclofen into areas that might affect the upper extremity. But interesting, in the stroke study we did, there did not appear to be any relationship between catheter location and control of upper and lower limb spasticity. So, and even when I'm placing the catheter, I keep almost all of my patients awake during the catheter placement, because I want to make sure I'm not bumping into anything as I drive the catheter up. Occasionally I'll have a patient who will report pain, because I'll bump into a nerve root, or I may bump into the spinal cord itself. You don't want a patient waking up after this procedure and being in extreme pain. So, having them awake, mildly sedated, really makes a big difference as you're advancing the catheter, and if some patients have had prior surgery on their spine, even more potential risk. So, for me, keeping them awake really makes a difference. So, I'll try to drive it up as high as I can in most cases, especially if there's upper extremity spasticity. So, again, we're delivering it through that catheter tip, right into the interthecal space. The actual dose, 100 to 1,000 times smaller than what we would see in the oral medications. And we do feel that it does reduce side effects. So, this is the technique. So, this is a patient that I placed an interthecal pump in. So, in some cases, depending on their body habitus, where they want the pump placed, it may be into the flank area, in that lumbar gluteal area, or it could be in the abdominal area. So, the first thing we do is we place a 14-gauge Tui needle, so a blunt tip, and I'll enter in it typically at the, start the skin incision at L5-S1, and then advance it into the interthecal space at L3-4. I go at about a 45-degree angle. It does two things. One, it also reduces any CSF flow that might occur around that catheter itself, but also it's a lot easier to allow the catheter to flow out of the needle into the interthecal space. So, the needle is placed, we see CSF, and then I will then inject that small white catheter. It's about the size of a piece of spaghetti with a stylet in the center of it to help give it a little bit more rigidity as I steer it up under fluoroscopy. Once the needle's placed, we'll do a cut down around the needle. This is the anchoring system that Medtronic offers. There's other systems I'll talk about, too, but this is a Medtronic anchoring system, and there's a little, like a butterfly that goes over the catheter, and then once it's in place, we release that anchor, and then it makes a tight grip around the catheter without occluding the catheter, and then the small holes are used for suturing it in place to prevent any movement. And then we will create a pocket. In this case, the pocket was created right adjacent to the placement of the catheter and anchoring system. And then this is an example of a Medtronic pump. We're going to fill the pump. The center hole or button is made of rubber. We use a non-coring needle, so the medication is put into the reservoir, and then we go ahead and program it. There's a small one that little point is another opening, which is the catheter access opening, and that is used in cases of concern where there's actually maybe a concern for a catheter obstruction. So, there's two holes in the pump, one for the reservoir for medication, one to enter right into the catheter access area. Attaching the catheter, you can see that that little button. I'm going to watch my volume again, but so you can see the catheter coming out, and then attach an extension catheter, and then that's connected to that tip. So, this is, again, the reservoir port, catheter access port. This is the part here where the catheter would be attached, snapped in, and we make sure that it's fixed properly without any potential risk of it coming loose. And then we place the pump into the pocket and secure it. There are small eyelets in the pump here, and it's kind of hard to see, but there's, right in this area, there's small little rings that the sutures would go around, making sure that we fix it so the pump isn't twisting or turning in that pocket. All right, so what are some of the benefits? Well, we've talked a lot about it, but the nice thing about this system is you can customize it. And, you know, we have patients who present with severe asbestos in the morning. They get up, and they've been sleeping, and now they're really tight. So, this gives us the opportunity to potentially give medications to them at certain hours. So, we can program the pump with continuous infusion, maybe a little more in the morning, a little more at night, maybe some more during the day if they're more physically active. Maybe we'll reduce the dose during the day because now they need it to ambulate, and they need that tone. So, it's kind of nice. You can do a kind of a nice flow diagram with that. And this is the other pump that's out there that's also approved for intrathecal baclofen. It's a nice pump. We typically will give patients brochures on both types and let them decide. It is a gas-driven pump. So, what's nice about this pump is when you put a needle in that center reservoir port, when you put the needle in, if there's medication, it'll actually flow back into the syringe. So, you feel really good that you've got your needle in the port, which is always a concern with some of these pumps is you want to make sure you're filling the pump or accessing the right place, whereas with, you know, because some of these pumps will develop fluid around them and it could fool you. So, with this one, it's nice. You put the needle in there, the pressure in that reservoir pushes the drug back into the needle. When you're injecting it, you're putting force down there, that pressure is actually what's going to drive the drug out, and then you could let go and you can see it pop back into your finger, and then you push it in, and once you get it filled, then you'll pull it out. They also have a catheter access port at the top, as well, as you see on this slide. Limitations with this pump are that the catheter is not as strong. It's an older version catheter, so we've had issues with catheter breakage utilizing this system. The Prometra One was not MRI compatible, and there were issues where people were not telling the MRI operators that they had a pump in them, they would go through, and then the medication would be automatically released continuously with severe, and even, I believe, death from overdose because of that, so that's always kind of Prometra Two, it too was designed to be MRI compatible. Having said that, though, there were some issues there, and so the recommendation is if you have a Prometra Two pump in a patient, the drug should be completely removed, they get the MRI, and then the drug gets put back in again. A little more tedious, a little bit more planning that goes on, so that is a concern with this. The gas-driven pump, though, has been shown to have a better dose range, so when you look at the Medtronic pump, and you're filling the pump, and it will tell you how much drug should be left in the pump, in most cases, there's a little bit more left in the Medtronic pump, which isn't always a bad thing when sometimes patients come in later than they should, but nonetheless, it's not as accurate. The Prometra Two has been shown to be very accurate in the amount of drug that it delivers over time, and it gives a small burst of drug, so it's kind of like a psss, psss, psss, depending on how you program it, so it opens the valve, lets a little out, opens the valve, lets a little bit out, so again, different format, it would be nice if the two companies could combine the technology, because there's some things I like about this pump and others that I don't, but overall, the Medtronic, at least to my eyes, they've been around a lot longer, most of the technology and the catheter types are pretty good. This is a programmer, I, the pump itself, let me show this to you, because I've got it in the bag. So, this is the actual programmer, right here, so you can see this, I'm going to, if I can turn it on while we're going through some of these slides. So, the one nice thing is, after you've placed the pump, or even before you've placed the pump, you're actually filling it in, you're interrogating it, you're telling this programmer what you're putting in, what the concentration is, what the dosage is, you're going to gain information, you're putting in patient information. So, this is a program settings, you're going to have the patient name, you'll have the serial number of the device, and then you move on. This is kind of a nice, it's got a nice diagram of the actual pump itself with the medication in it. And this is, again, another aspect of what we're seeing on the screens. And this is a 40 milliliter pump that they're using, and then this is an example of the flex dosing, so you can actually set it for certain times that allow you to be able to work through what might be best for the patient. And typically, when we implant the pump, we're going to do a simple continuous, relatively low dose, and then we will make adjustments in the office. So, with ongoing management, let me go ahead and show you this, since we pulled it up here. This is an example of the actual programmer itself. So, when we evaluate the patient in the office, what we will do is we take this device here, and this goes over top their skin. And then, we'll go ahead and interrogate the pump. This is a nice demonstration of what actually would be happening, where there's a communication in progress. It's reading the pump, as we like to say, and then it gives us information. It tells us about the patient name, the device. It'll tell us when the battery's going to run out, when the pump has to be replaced. We put in there the actual concentration, and then we move on. This is a nice diagram in which you can actually see the volume of the pump, how much is in there. So, the green meaning that there's some medication in there, and then we'll go on to infusion. This talks about how much they're going to receive in 24 hours. It talks about how much they'll receive in an hour. We can make changes into the pump itself. If we want to give a bolus, we can give a bolus. If we're concerned that maybe they're reporting that the pump is not working, if we give a quick bolus in the office and see if they have a reduction of tone, that's kind of a nice way to verify that the catheter's patent. There's a PTM. This is a patient therapy manager, so the patient's are actually given what looks like a cell phone that they can interrogate the pump themselves, and they can also, if we program it, allow them to have a bolus. So, they can actually give them a bolus of medication if they would like, and also if there's any alarms going off. Maybe they forgot to get the pump filled. Maybe something happened internally with that pump, a motor stall or something. That alarm will go off. They can actually place it on there, and the device will tell them what the problem is, and then they call the physician who's managing the pump to let them know, hey, my pump is alarming. It's showing this problem, and there's also the setting with the alarms. We like to set alarms when the pump volume is getting low. So, if there are only two milliliters left in the pump and they only have a certain amount of time, and maybe they missed an appointment, maybe there's a scheduling problem, maybe they were in the hospital, that alarm's going off, and then we can have enough time to get them in the office to fill the pump, and those issues are so critical with these types of patients. We like to think that with patients, when we put a pump in, there's a saying that you marry the patient, and I wish there's a lot of truth to that. I mean, I can't tell you how many times I've met a patient in the emergency room to fill a baclofen pump because they were on a vacation and they didn't keep their appointment, and now my alarm's going off, I'm starting to see increased tone, and it always seems to happen on a Friday night. Don't ask me why, but so there I am in the emergency room with an emergency baclofen kit and a needle and filling their pump and giving them a bolus for what they might have missed, but there is that relationship there. So, you have to be prepared, and if you're not able to be available, then you need to make sure there's other providers that can be there for you. The same thing goes true if there's a, for a while, Medtronic had issues with their pump's motor stalling, and when it stalled, it stopped. So, we had patients who were calling us, my alarm's going off, I'm going into withdrawals, and I'm, Friday and Saturday nights, I'm in the operating room putting in a new pump, you know, so that issue of being prepared is so critical with these types of patients because baclofen withdrawals will kill a patient. So, what happens is that baclofen withdrawal results in increased tone, muscle rigidity, and then after that, they tend to go into rhabdomyolysis, and then they go into renal failure, and then they become comatose, and they stop breathing. And, you know, we've been able to prevent that from happening by aggressive management. So, when that happens, they're going right to the emergency room, they're going right to the ICU, and then we're actually, you know, in some cases where we've seen issues with having to do that, it has to do with infected pumps and other things where you need to get the pump out, but you don't want to take it out too quickly, and so you're working through a variety of different techniques of valium and ciproheptadine and baclofen and tizanidine, and you're going through this whole protocol that we follow for patients that are going through baclofen withdrawals, or we're inducing a baclofen withdrawal because we have to get this infected pump out, and those are issues. If the catheter gets tangled, how are you going to handle it? How are you going to troubleshoot it? If the pump gets infected, how are you going to handle it? Are you going to take it out yourself? Do you have someone you can call immediately? We have an incredible team of outpatient nurses in the community managing our pumps. We have two full-time nurse practitioners in our office managing these pumps. We have an incredible Medtronic team who are there at a moment's notice, will meet us in the emergency room, wherever it may be, right away, and we have an incredible group of neurosurgeons. Even though I do a lot of the cases myself, there are some cases where I rely on their help, and so I can pick up my phone. I've got all their cell phones. I call them and say, hey, I've got an issue here. Can you help me? And they're always there to help out. So having that relationship in the community, if you're going to be managing these pumps, is so critical. So these are the things that you need to take into consideration if you're going to be managing these types of patients. It's an incredible therapy. It is a gift to your patients to be able to offer this, but you need to make sure that you have so many other factors that go into this as well. So active involvement, cooperation, medical professional team, and then the issues of basically understanding the symptoms of back lift and withdrawal, and then also making sure that they keep their appointments. That's always an issue, and that gets into the issue of choosing your patients wisely. We talked about the surgical issues, but what about the social issues? Does this patient have a supportive family? Are they intelligent? Are they responsible? Are they going to be? And that's why a lot of times, I'll occasionally get a call. I've got someone in the hospital that's in real spasticity. We've tried everything. Can you put a pump in? The answer is no. We're going to see them in the office. This is a gradual decision-making process that involves the entire team, their supportive caregivers, whoever it might be, and then we make that decision. And also insurance. Will insurance cover it? Will they cover the refills? How are you going to handle that? In fact, some of the things that led us to involve outpatient nursing is sometimes there were insurance billing issues that we could involve them in. So basically, you know, you've got to make sure that you have all of these things together before moving forward. This was a really nice article. This was just published, I think, the last journal of PM&R. So I went ahead and took a copy of it, but if you were to Google this or look it up in the PM&R journal, instituting an intrathecal back-up program at an academic institution. It wasn't quite how we did it. Ours was kind of a gradual process over about 10 years of slowly bringing things on and putting the pieces together slowly. But they were able to put together a team at, I think, the University of Pennsylvania, working with neurosurgeons, interventional radiologists, training the nursing, the staff, and even training your staff. Patients coming in, they're going to get a pump refill. Well, something happens, and now you've got to reschedule. They know those patients have a certain time they need to get back in to get that pump filled. So anyway, this is a really nice article. So if anyone is interested in starting an intrathecal back-up program, this serves as an incredible guide, very informative. It also has some very good references. There's a Mike Salino in Moss who is very engaged in intrathecal baclofen therapy, does a lot of talks at NANS and at our academy meeting. And so, you know, there were articles that he put in on various processes and techniques and clinical guidelines on intrathecal baclofen trialing and maintenance and troubleshooting, you know. So they're all very good. And our academy also always has a really nice presentation on challenging cases, too. And Dr. Ivanhoe has been involved with some of that. So anyway, if you're interested, I would encourage you to read this article if you're interested in starting a program yourself. But they really had some great insights. So benefits are pretty clear. You know, not everyone's going to get the amount of relief we hope, but for the most part, it seems to give a long-term control. And that's the nice thing about intrathecal baclofen is it's not the ups and downs of oral medication, not the ups and downs of Botox and phenol. It's a continuous infusion that really can give a nice adequate control throughout their day and also allowing patients to be more independent, to feed, dress themselves, sit more comfortably. You know, one of the cases that we had for our stroke study presented to me, he had had a stroke five years earlier, a young man in his 50s. I say now that I'm 61, everybody's young if they're under 60. Fifty-year-old man had a stroke, hypertensive stroke, and he had pretty severe spastic hemiplegia, arm pulled up to his chest, fingers tucked in. And he was able to be independent. He could dress himself. He could bathe himself. He had his cane, and he walked with his stiff-legged gait, and he presented to me, not because of spasticity, but because his shoulder hurt. He couldn't. So, you know, I worked on physical therapy, shoulder steroid injections, other things. But I said, you know, I think we can do a better job with your spasticity. And so we tried all the other things, too, but ultimately we did an intrathecal back-open trial. It was a dramatic improvement in tone reduction, and then he went to be implanted. And what really was remarkable was that it really wouldn't have changed what we considered the FIMS scores. You know, he was still independent in everything. But what it did was his gait pattern improved, and his arm went from this to this. He said, now I can carry a grocery bag with my involved extremity. Now I can walk more fluidly. I don't need my cane anymore. And what was interesting is he felt more comfortable going out in society, interacting with people more comfortably. And for him, that was an emotional experience. In fact, even when we were doing the study, they actually filmed him, you know, and we also had some videos of his gait pattern improvement. It was dramatic. But it wasn't really the issue of what we see, you know, with the FIMS scores and all that. It was really just a quality of life issue that really made a difference for that patient. So, anyway, those are the things that we typically will see with that. Let me go back to the slides here, okay. And this was interesting. He was the same, and at five years, this patient's pump's been in place for probably about eight years now, and, of course, you know, when the time came to replace the pump, there was no question he was going to replace that pump. So, you know, it's amazing the satisfaction the patient's experienced with this. Now, again, you know, the issues of risk, surgical complications. It's a surgery. They're putting a big device, not the size of a hockey puck, in their body, you know. So, it is something we have to be mindful of. No infections. They have to be aware of the risks of abrupt discontinuation of back-lifting, the back-lifting withdrawals. Side effects, overdose, I don't know if I would say that we've seen overdoses in intrathecal therapy. I guess the closest I came was one time I did a procedure where a patient had upper and lower limb spasticity, so he asked if we could move the catheter up higher into his thoracic spine. So, I moved his catheter up. We kept the dose a little bit lower than what we had been delivering in the lumbar spine, but the actual dose was still so much that he became very somnolent, not very easily arousable. So, we quickly stopped, turned the pump off, and then once he started to become more aroused, we turned it back on at a lower dose, and it's worked out well. So, that's typically what we see. I wouldn't say that we see concerns of respiratory depression, but these are potential risks, of course, certainly in high doses. And then other issues, you know, with intrathecal therapy, you need to have a trained team that knows how to fill these pumps. The risk of a pocket fill is there, so, you know, you need to make sure that you're in the pump, you make sure that you evaluate, that you're getting the amount of medication you expect out of that pump, and when you fill it, you're making sure that that drug is going into the pump and not around the pump. So, these are issues that you have to be concerned about, and then, of course, there's always issues of catheter obstruction, catheter migrating out of the intrathecal space. Most of these cases, when it occurs, usually are not emergencies because it tends to be a gradual process, and then also battery issues, too. This is an example of one of my patients. I get a text, Dr. Creamer, the pump is coming out through my skin. So, this is the catheter access port, and that white line is the catheter. So, this is a patient who had the pump in for many, many years, and it eroded through the skin. So in this case, admitted to the hospital, a tapering of the dose, typically over about five days, we were cutting it by 50 percent each day. And then once the dose was low enough and they were on oral medications, then the pump was removed. So anyway, these are just examples of the benefit of intrathecal therapy. Things that, obviously, might not necessarily be registered in. So this is the sister study. This was a lot of the articles you read about with intrathecal therapy, and when I did the literature review on this topic, a lot of them were kind of, well, we looked at five patients and they got better with intrathecal therapy. There really wasn't any real studies that actually looked at, we took conservative management and we went ahead and we tried intrathecal therapy and we randomized them. So this was a randomized study looking at the effectiveness of intrathecal baclofen in the stroke population. This was presented at the International Society of Physical Rehabilitation Medicine and the AAP meeting back in 2020. So again, World Health Organization, we're looking at 15 million people suffering a stroke and also a significant percentage of these developing severe disabling spasticity. The options, again, oral or the intrathecal route. So this was the study design. So basically, we found patients who had met the criteria, had significant severe spasticity, unresponsive to conservative treatment, and continued to have limitations in their quality of life because of the spasticity. So these are patients that didn't know which arm they were going to get into. So once they were felt to be good for an implant, surgical implant, intrathecal baclofen, or conventional medical management, we put them in a computer, we pushed a button, and then they were kicked into one or the other group. Whether they liked it or not, they agreed to the study. So we randomized them. So some went into conventional medical management. That was continuation of oral antispastic medications and also therapy, physical therapy, two times per week. That was considered over a six-month period of time. Or they received an intrathecal baclofen trial, and then if they were successful, they had the pump implanted. Primary outcome was spasticity measured by the ASHRA scale in the lower extremities. Secondary outcomes, we looked at upper extremity spasticity control, function, pain, quality of life, patient satisfaction, and whether there was any adverse events. We looked at when was their last stroke. They had the stroke at least six months prior to involvement in the study. Spasticity in at least two extremities, and then an ASHRA scale greater than or equal to three. A minimum of two of the affected muscle groups in the lower extremities had not received Botox, and they had not reached their own personal goals. So this was an international study, and it involved 18 sites throughout the world, 11 in the European Union, and seven in the United States. We randomized 60 patients, ultimately 24 patients completed in conventional medical management, 24 in the intrathecal pump implantation. They were predominantly male. This is interesting, though. Look at the age. It's in their 50s that these patients were in the study, and the mean time since the last stroke was about five years. So these are people living with spasticity for five years before someone even offered them the possibility of intrathecal therapy. And the spasticity duration, roughly about the same. The stroke type was fairly equally equal in ischemic versus hemorrhagic. Most of these patients seemed to be high level, indicating that they were able to walk or take care of themselves. The ASHFOR scale was utilized, and we looked at a variety of different muscles in the upper and lower limbs. And then we went ahead and measured spasticity at baseline, and we compared it to the conventional medical management patients. And what was interesting is there was a statistically significant reduction in tone utilizing the ASHFOR scale with patients receiving intrathecal therapy. We also looked at the FIM, Functional Independence Measure, and as we're all familiar with 18 items, assesses a variety of different aspects of a person's mobility, and we utilized that as well to determine a baseline and then determine if it made a difference in their care needs. And what was interesting, the FIM score didn't really change. There was no statistically significant difference. And as I mentioned before, there are other aspects, I guess you could say, that really seemed to make a difference. So we presumed that they were able to do everything, but hopefully it was in a way that was a little bit more easier for them and their caregivers. And then we looked at the pain rating scale. So this is the 0 to 10 scale, but we asked them three questions. What is your actual spasticity-related or spasm-related pain, so what are you feeling right now? What's your least over the last week? So 0 to 10, was there a day you were really comfortable? Was that 0, maybe 3? And what was your worst? When it really grabbed you, what was it worst? And what we found here is that at least in actual pain, there was a statistically significant reduction in pain in the intrathecal baclofen group. Then we looked at, since this was an international study, we used a Uroquois five-dimension scale, which looks at quality of life. So describing mobility, self-care, and anxiety, depression, pain. No problem, moderate problem, extreme problem. We also used a health status visual analog scale, which 100 is fantastic, 0, I'm miserable. And we had them also score that before and after and during the use of intrathecal therapy. And then we also looked at the stroke-specific quality of life, and this was designed for post-stroke patients. You can see this is a variety of scales, and they scored as strongly agree or strongly disagree in various domains, indicating better quality of life. So higher score, better quality of life. And what we found that in some domains, especially the utility score, there was a statistically significant improvement in the intrathecal baclofen group. And these are some of the different areas that you could indicate that significant amount of extreme problems in so many of the domains. And this patient satisfaction was also asked, would you do it again? Would you recommend it to a friend? And there was a higher degree of patients in the intrathecal therapy group who would say, yes, I'd do it again, and yes, I would recommend it to a friend. Adverse events. Well, there were a few. Drug device procedure, you can see the percentage. But they were all considered what we know to be expected with implantable devices and intrathecal therapy, so there were no surprises there. It seemed to be consistent with what is in the literature. It's important to realize that all serious drug and device-related events were successfully resolved for the patient. And no patient stopped the intrathecal baclofen therapy due to the adverse events after implantation. And then these are also some of the adverse events that occurred. Muscle weakness, hypotonia, urinary retention, somnolence, and fall were identified. So again, things that we already kind of knew about, but again, we're always being mindful of. And the serious adverse events, urinary retention, constipation, what's the term, bowel obstruction, peripheral edema, seizures, hypotension, and there were issues related to device dislocation, occlusion in one patient. But again, same thing as all serious adverse events related to the drug or device were resolved. So we were able to successfully treat that with no harm to the patient. So in conclusion, as it relates to this study, this was the first randomized controlled trial comparing intrathecal baclofen therapy versus what we consider our conventional treatment. There was a significant, a statistically significant reduction in muscle tone in the upper and lower limbs in the intrathecal therapy group. Trend for improvement in FIMS scores, even though it wasn't statistically significant. Significant improvement in pain, at least in actual pain, and also the EuroQOL utility score looking at quality of life. More patients that underwent a surgical implantation of this pump were satisfied than the people who didn't. And while there were more adverse events in the implanted group, they were, again, consistent with what we'd expect with any surgical treatment of this nature and the medications administered. And these are the researchers that were involved in the study, and it was published in the Journal of Stroke and the Journal of Neurology and Psychiatry as well. So there was two publications that came out of this. So again, reducing post-stroke spasticity. Medtronic has a lot of different resources, Fluonix does as well. So anyway, we went over a little bit for this talk, but I can take some questions. The other one's going to be a little quicker, I would say. Do you do, on your implant, do you do purse string? The only time I use a purse string is when I'm taking the device out. So if I'm removing the catheter, then I will put three purse strings, because I don't want any CSF leakage. But when I put it in, the anchoring system and the fact that I use a 45-degree angle creates such a distance that we don't typically see CSF coming around that. So that would be how I would do it. Dosages? Are you just titrating to effect, basically? That's right. So we'll start out with a 50-microgram trial. Typically, the patients are only going to stay in the outpatient surgical center for about eight hours. Anyway, it's all done as an outpatient in most cases, not always, but most cases. We'll start them at the dose that they did for the trial. I know there's some literature that would support doubling that dose, but in most cases, in that situation, those are people that are staying over the night. And if we do have them stay overnight, then we give them a much higher dose to start out. And then we typically will go up by 50-microgram intervals initially up until we get to a couple hundred micrograms per day. And then we typically will do a 20% or 10% increase, depending on the patient, and always involving the patient in that decision, too. Any other questions? After the sister study was done, did a significant number of your patients that were on conventional management, did they choose to go to intrathecal therapy? I think most of those patients actually did, because they already wanted it in the first place. So I think a significant percentage did. Not all of them, though, but some of them did, yeah. I had a question. So I had a question about, you had on your slide that after a TBI, you need to wait a year before intrathecal baclofen? What was that again? Oh, a year? Yeah, after TBI, but not after a stroke, or not after? Yeah, not after a stroke. For some reason, most of the insurance guidelines require a year time period. And I think even the strokes, even in that clinical study, which they tried to work, because all those patients were actually covered by insurance when we implanted for the sister study, and that was that six-month mark for those, too. And then it sounds like you're using baclofen and tizanidine together a lot of times? For oral use, many times I will start off with baclofen and see how they do, and then determine whether it's effective. If it's not, then we may take the baclofen up, or if there's a limitation and they get to a certain point with oral baclofen, then we'll keep them on that dose if it's providing some relief, and then we'll add oral tizanidine in addition to it, so a combination of the two many of our patients do utilize. And occasionally, we have patients even on Valium, which is kind of interesting in the state of Florida, because I'll get a phone call from the pharmacist, your patient's on two muscle relaxers. He says, we can't do this. Well, he's a T12, he's a spinal cord injured patient. He really needs this medication. It's not your typical antispasticity patient. And then last one, are you monitoring liver enzymes with your tizanidine patients? Occasionally, we will. Typically, they're going to be seeing their primary care physician. They're getting routine labs. So that's typically how we would monitor this follow-up with their primary care physician. Yeah, hi. So over long terms with your patients, are you noticing any large fluctuations in dosages? Or once you get them stable, you tend to, is there some certain range that you tend to keep your patients at? There's no certain range. We actually looked back at our patients probably about six years ago and actually looked at dose ranges in our patient population. And we found that MS patients and spinal cord injured patients seem to require a lower dose, maybe a couple hundred micrograms per day. And then we're looking at cerebral palsy and traumatic brain injury somewhere from 800 to over 1,000 micrograms per day. We do find that in most of these patients, once they get to a fairly stable dose, we're not really having to make any adjustments. So most of these patients seem to be stable. That's not always the case, though. There have certainly been reported cases of people developing a tolerance to the baclofen. And we've had some cases where we've taken it up to over 2,000 mics per day, and then it's not working. Then we'll start to wean them down to maybe even put saline in the pump and then start all over again with a good effect. So that is a concern. And we do utilize other therapies in addition to the baclofen if we need to. So what was interesting is the medications Econotide, or Pre-Alt, is a medication that is approved for intrathecal use for pain. And so we had a patient who had spastic paraplegia of unclear etiology, a relatively young man. And we did a baclofen trial, and it did a great job in controlling his spasticity. But he still had a lot of neuropathic burning pain. So we did a Pre-Alt trial on him, which did fantastic. And when we went ahead and added the Pre-Alt to the pump, it actually reduced his spasticity substantially. Now, having said that, he had one of the experiences in which he developed some psychotic behavior, which required us to, then he said, take it out. He was still on a low dose. We took it out. His spasticity increased to such a degree that he couldn't void anymore. He was spontaneously voiding, and he couldn't walk anymore. So he said, put it back in. So we put the Pre-Alt back in at a much lower dose than what was causing the psychotic episodes. And now he's happy, and he has a Pre-Alt and baclofen. And in some cases, we'll even add Marcane to the patient. And in some cases, we may even add some low-dose opioids, too. So there are maybe one or two patients that actually have multiple drugs in their pumps for various reasons. Also, intrathecal Clonidine. You know, I used to use intrathecal Clonidine, and it is on the poly-analgesic consensus statement as a drug that can be utilized. However, the issue that I have with Clonidine is we've had several episodes in which the pump failed, they didn't get it filled in time, and they developed significant hypertension. One lady who had a pump failure, unclear. Her hypertension was so severe she had to be intubated on a ventilator with IV pressers. It was a nightmare. I don't even put Clonidine in my pumps because of the experiences I've had. We've got a few that when we started to wean everybody down after these experiences, that I actually left it in some patients' pumps. So we have a few. But it isn't something I use very often. But it is indicated, and it's in the guidelines. Yeah, it works as an analgesic. Yeah, that's right. So it's out there. I would just say be cautious with it, certainly in my experience with it. Along those same lines with pump failure, I mean, you obviously don't want to have abrupt cessation of Baclofen either. So have you had to deal with a pump failure when a patient's on a significant amount of Baclofen in the pump? And if so, what do you do in the meantime orally to mitigate that? So the most important part with that type of thing, if you have an acute Baclofen withdrawal either from a catheter disruption or from a pump failure or they didn't get their pump filled, the biggest problems have been when the pumps just automatically fail for whatever reason. We haven't seen that since the Medtronic made a revision to their pumps. But if that's the case, you admit them to the hospital, you try to correct the problem if you can. If it's an infection, you really can't. So then you're having to wean them down. So typically in that case, we're going to put them on high-dose Baclofen, 20 milligrams four times a day and go up to 30 milligrams four times a day maximum. Then we'll add Valium, 5 to 10 milligrams, three to four times a day. We'll also add the Tizanidine. We also will add Ciproheptidine, periactin, very effective medication for Baclofen withdrawal. So we've been able to really make a difference and we've not had anybody end up with renal failure or on a ventilator from this before. The only one I had was way back when and the pump got infected, the doctor took it out right away, just went in there and took it out that day and he was still on 800 mics of Baclofen and boy, that patient went through it. Now when we have a patient, if it's a pump failure, we're going to put a new pump in. If it's an infection, we're going to take it out then with a slow wean while we're increasing the oral medications. We've been very successful in that regard.

neurological approaches

spasticity management

intrathecal baclofen

spinal cord injury

cerebral palsy

strokes

rehabilitation

injection therapies

quality of life

treatment modalities

baclofen withdrawal