Mike Jaasma on Spinal Cord Stimulation for Diabetic Neuropathy

David Klonoff: 0:19

Hello, welcome to Diabetes Technology Report. This is the Diabetes Technology Society podcast about technology. Today we have a very important guest who's working on a problem of diabetes that affects many people. I'm Dr David Klonoff. I'm an endocrinologist at UCSF and Sutter Health. My co-moderator, Dr David Kerr, will introduce today's interviewee.

David Kerr: 0:47

Welcome everyone and great that you can join us. Today we have Mike Jasmur. I'm especially pleased that Mike's on this podcast today because when I was in the United Kingdom, I spent every Thursday afternoon for more than 20 years running a clinic dedicated to the treatment of painful neuropathy caused by diabetes. I had lots of ups and downs. It's an incredibly common, incredibly difficult problem to deal with. How did you become interested in this? Yeah, well.

Michael Jaasma: 1:25

My background is in biomedical engineering and through my career I've gotten into medical devices and specializing in running clinical trials. I work at Nevro, which has a spinal cord stimulation device to treat painful diabetic neuropathy, like you just described. What really drew me to this technology was the profound impact it has on pain relief. Our clinical trial has demonstrated over 80% pain relief on average for patients out to two years follow-up. Just a profound effect on this very difficult to treat problem for people with diabetes.

David Kerr: 2:06

Do you think that it's underappreciated just the magnitude of the problem of painful neuropathy and how difficult it is to manage?

Michael Jaasma: 2:18

I think that's very true. When we look in the literature, the conventional management for the disease includes gabapentin, pregabalin, deloxetine. We see reports that those work reasonably well sometimes, but our experience is that those do not work for the majority of patients. Either they don't relieve the pain or they have significant side effects that cause patients to not to discontinue use of those medications. So I think it's maybe it's an underreported problem. It's difficult for us as a company to figure out who exactly is seeing these patients and who is working with them on their painful diabetic neuropathy. We're trying to get the word out that these patients should be sent to pain management physicians who have access to spinal cord stimulation to treat this problem.

David Klonoff: 3:15

Michael, could you explain what is spinal cord stimulation, how does it work and what happens to a patient who wants to try it?

Michael Jaasma: 3:24

Yes, spinal cord stimulation uses an implantable device to send small electrical signals or stimulation to stimulate the spinal cord and this essentially blocks or turns off pain signals that are sent from the legs and the hands to the brain. The device has two main components there's a pulse generator which has a battery, it's pacemaker-sized and it provides the electrical signals and this is connected and this is implanted under the skin, either in the lower back or the buttocks, somewhere in that region. And this pulse generator is connected to small wires that are placed in the epidural space at the back, so the same part of the body where, for example, women get an epidural injection when delivering a baby and these small electrical signals are sent to the epidural space, which stimulates parts of the spinal cord to, like I said, block these pain signals from getting to the brain.

David Klonoff: 4:20

Does everybody receive the same amount or number of electrical signals and if not, how do you decide how much electricity to put into the body?

Michael Jaasma: 4:30

Yes, so there is an optimization period after the device is implanted. The magnitude of the stimulation there's a range and you know it will start off at kind of the typically optimal level, and then that can be adjusted by the engineers who work with the patients to optimize their therapy. I work at Nevro and we have now an AI-powered system that received FDA approval last year and this then allows the patient to daily check in on their app and say how they're doing, and then it goes through a AI algorithm to figure out if that therapy should be tweaked to optimize pain relief even more.

David Kerr: 5:17

Mike, if I was a person with diabetes, with painful neuropathy, its episodic is unpredictable, as you say, the treatment is really difficult. But who is the ideal candidate for your technology?

Michael Jaasma: 5:33

So for our technology it is an implant, so it's for people who have had poor success with conventional medical management. So the typical medications those should be tried first. If those do not work, then spinal cord stimulation is a great option. So what we typically recommend is that patients have at least five out of ten on a pain scale for their diabetic neuropathy pain. For diabetic neuropathy patients our recommendations are that they have an A1C10 or under, so they have reasonable control at least of their blood glucose levels. And those are really the two big requirements for the device.

David Kerr: 6:22

And when I remember that in the clinic there were different types of pain. There was the aludinia, there was the electric shocks, there was the deep gnawing in the bones, miserable pain. Does your technology is equally effective of these different types of pain or is it particularly suitable for certain?

Michael Jaasma: 6:43

types? Yeah, that's a great question and we definitely find that patients experience the pain in different ways. What we found is that it works very well for all of these types of pain conditions. So, like I said, out to two year follow-up, we have an average of 80% pain relief. And in the field of pain management, we talk about responders to the therapy having at least 50% pain relief At two years. Our therapy, which is never makes a high frequency stimulation, which is an imperceptible stimulation compared to some of the other low frequency stimulations out there, what we found is that the responder rate is 90% of two years. So nine out of ten patients see at least 50% pain relief in two years. It works really well.

Michael Jaasma: 7:32

And then I think you kind of alluded to another aspect a lot of these patients it's not just pain. You know, there can be other symptoms tingling, numbness and we found that our device works well to treat those symptoms. And in addition to that, the numbness, these people often have reduced sensation in their feet, which can lead to diabetic foot ulcers which eventually can lead to amputations, and we found that we can actually improve sensory function in the feet of these patients. We have patients who can't feel anything in their feet. They get the therapy and now they can feel their feet again. And what an impact that has on patient's lives of not just relieving their pain but also allowing them to feel their feet, prevent foot ulcers from forming but also just go about their daily activities that they possibly were afraid to do, do to fall risk of not feeling their feet. So just a lot of different improvements for patients.

David Klonoff: 8:35

Michael, I haven't seen much about other benefits of spinal cord stimulation besides the very important feature that it relieves pain. Is there much in the literature about other benefits? Are there other benefits?

Michael Jaasma: 8:51

Yeah, and, like I just alluded to, pain is the main thing. Spinal cord stimulation is treating and it does very well at treating and reducing pain for people with diabetic, painful diabetic neuropathy. But we're finding, as the field is moving forward, we're looking at all of these other aspects of clinical benefit. So when you reduce the pain, you improve quality of life. We've seen clinically meaningful improvements in quality of life. We've seen meaningful improvements in sleep quality, we've seen improvements in overall functioning and for people with diabetes, what our data has shown is that we can actually help them to reduce their A1C and reduce their body weight. So what we think here is possibly not the stimulation itself causing changes in A1C or weight, but reducing pain, which allows patients to focus on other aspects of their life, so managing the blood sugars, being more active. We see all of these kind of comprehensive benefits. And then I also mentioned before the sensory improvements in the feet. Just you know and not seen before, disease modifying. You know treatment effects and that's really a huge benefit to these patients.

David Klonoff: 10:13

Those are all very positive, especially from my perspective, if you have improved A1C and improved weight. What sort of risks or side effects should people be aware of before they have one of these procedures?

Michael Jaasma: 10:26

And the. You know it is an implant, so there is a implantation procedure, so there's always a risk of infection with the surgical procedure. What we found is that the risk of infection in people with diabetes is similar to that of the general patient population for spinal cord stimulation procedures. So that's in the, you know, two to six percent range for infection rates, very similar to what happens with pacemakers and other similar type devices that are implanted under the skin. So that's one of the main complications, the. There are other less common complications, just some, you know residual pain from the procedure, general surgical procedure issues that can come up.

David Kerr: 11:20

Mike, can I just ask you just some practical things? I mean, how often do you have to have this replaced? Can you walk through an airport without any, without alarms going off? Can you go for an MRI scan with it? These sort of practical things for people considering having this procedure.

Michael Jaasma: 11:41

Yeah, good question. So the device has a battery in the pulse generator that's implanted under the skin. There are non rechargable battery options out there and then there are rechargeable battery options. There are many more devices now with a rechargeable option. So with the Nevere device it's a wireless recharging. So you just wear a belt similar to how you'd wirelessly charge your cell phone, so you just wear that belt for about 30 minutes a day or an hour every couple of days to charge your device. As far as airport scanners, that's safe to go through those and there are things that need to be thought about for MRIs. Most devices now are compatible with MRI in some situations and you know you need to talk to a physician about those types of MRI scans. Mainly, the device can be turned off while the MRI is being taken.

David Klonoff: 12:43

Mike, would you say that the number of people in the US who are having a spinal cord stimulation implant is it increasing? Is it increasing rapidly? Is it pretty steady? What do you think?

Michael Jaasma: 12:55

Yeah, definitely for the diabetic neuropathy patient population. The numbers are expanding, with Nevera was the first company to introduce this specifically for treating painful diabetic neuropathy, with FDA approval in 2021. The number of patients becoming aware of spinal cord stimulation for their painful diabetic neuropathy is increasing on a month-by-month basis. We're doing a lot of work to get the word out, both to patients and to physicians, endocrinologists, podiatrists, neurologists, family care providers these physicians that are really treating diabetic neuropathy. First for these patients getting the word out, there's definitely more knowledge about the therapy and what it can do. That's turning into more and more people getting spinal cord stimulation.

David Kerr: 13:52

It doesn't have to be diabetes, because of the painful neuropathy. I guess this technology works for any kind of peripheral neuropathy that results in pain.

Michael Jaasma: 14:05

That's correct. The therapy has been shown to work for other types of peripheral neuropathies. The initial application of spinal cord stimulation was for back and leg pain. Chronic back and leg pain, that is the neuropathies, painful neuropathies. Normally people with those conditions are candidates for spinal cord stimulation.

David Klonoff: 14:27

Mike, I have one last question for you. How easy or difficult is it for a person to get coverage from their insurance company if they're thinking of having this type of procedure or device implanted?

Michael Jaasma: 14:42

Spinal cord stimulation. For the conditions that we mentioned back in leg pain, painful diabetic neuropathy Conditions are covered by all major insurance providers. In the US they're also covered by Medicare for all regions. Now it's becoming more and more accessible for patients.

David Klonoff: 15:03

Michael, I would like to thank you for spending the time explaining spinal cord stimulation to us today. I want to thank our audience for being part of this podcast. David Curran, I look forward to you joining us for the next version of Diabetes Technology Report. This podcast is available on the Diabetes Technology Society website, as well as on Spotify and the Apple Store. Until the next podcast, michael, thank you for joining us, and more to come. Bye-bye.

David Kerr: 15:37

Thank you, michael, thank you Bye.