Okay, so next, I'd like to present Majid Gurgis, all right, well, he is going to be talking to us today about spinal cord stimulation at 10,000 hertz for the treatment of chronic upper limb and neck pain. So thank you everybody for being here today, and thank you for having me to speak in the pain section. I am actually presenting this on behalf of Dr. Amar Feldin, who is the principal investigator in that trial, and also presenting on behalf of a sponsored trial by Senza System or Nevro Incorporation. I think this is not my disclosure, I wish it was my disclosure, this is Dr. Armofan's disclosure, I only consult for Nevro and Hilliard, I have research grants from Abbott, Boston Scientific, Nevro, and Hilliard. So today, I'm going to talk about using high frequency stimulation for chronic upper extremity and neck pain, knowing that use of neuromodulation for axial neck pain have not been discussed as far as on label for the U.S. trials. So that original study came from Australia, this is the U.S. study, and I'm presenting the 12-months data. The full presentation would happen in January of 2019, hopefully presenting the whole subject of this trial. As you all know, people with chronic upper extremity pain or neck pain, specifically post-surgical or non-surgical patient, is a very difficult cohort to treat. Multiple regimens have been trying to treat those patients, including conservative measure, antibiotics, adjuvant therapy, intervention, which I do a lot of on day-by-day basis, and there was no particular success or particular success that outcome for stay for a long time using those conservative measure. Parathesia-free or conventional stimulation has been tried before for that particular cohort where we used anterograde placement, percutaneous lead, retrograde using paddle lead with very limited success. So I'm going to present our newest trial using the high-frequency stimulation or the SENZA system using a 10,000 kilohertz stimulation for upper limb and chronic neck pain. For this particular trial, there were 42 subjects that went to permanent implantation after successful trial. The device had been approved by the FDA earlier in 2015. It has been approved in Europe about three years before that. Our inclusion criteria for this study was chronic and tractable upper limb and neck pain, lasting refractory conservative therapies and lasting over three months, and the average VASA score for pain was above 5 out of 10. We excluded patients with mechanical instability, significant cervical stenosis or epidural scarring, or particularly surgery of the posterior element because that trial was done with the SENZA PERX lead, which used anterograde placement, and for the difficulty of placement, that was one of our major exclusion. One of the major exclusion also was trial of previous pinacostimulator. Those leads were implanted between C2 and C6. We used this regular parameter for high-frequency stimulator approved by the FDA for the SENZA RCT trial. The statistics were reported based on 42 subjects at baseline. I'm going to present only 15 subjects at 12 months. I'm going to give you a view of 3 and 6 months to more than 15 subjects, but for the sake of the presentation, I'm going to stick to those 15 subjects for 12 months. We use significant statistics with a p-value less than 0.05, and for the protocol population, we only present the people who met the primary endpoint of this trial. So out of 42 subjects, there was no neurological deficit or neurological manifestation sequela from implanting those devices. None of the subjects experienced any paresthesia after the implant. This is a paresthesia-free device. Out of those, there was 15 related adverse event that didn't end with any serious complication. So there were 51 people trial. Out of those, 47 were successful. About 4 of those successful trial opt out from having a permanent device, and one person did have a permanent device and explanted just after the first visit. Out of those, you can see there's 90% of them had neck pain with VASCOR above 5. About 90% out of those who had upper limb pain were also implanted, and our primary endpoint was measured at 6, 9, and 12 months. So this is the 3-month responder rate, and you can see out of all patients, we have 79% was the neck patient. There was about consistent of 79%, and upper limb, there was about 83%. The 12-months data that represent those 15 subjects, we can see out of those 15 subjects, 87 were responders, 87 were responders in the neck pain population, and about 100% in the upper extremity population, which definitely might subject to change once all subjects reach the 12 months. So these are presentation of the VASCOR from baseline drop, and you can see here at 3 months, 42 subjects dropped from 7.6 to 2.6. We have about 36 subjects at 6 months dropped to 2.5, and the 15 subjects we're talking about today dropped to about 1.7, and that's about total percent of 76.5 pain relief. Now for the upper limb population, you can see very, very similar results out of 3, 6, and 12 months, about 87% pain relief. Now I have a very famous debate in INS in 2016 about pain remitters that was attended by Dr. Robert Levy, Dr. Slavin, and Dr. Leo Capra. I would present that because it happened to be in the slide. There's multiple definitions about chronic pain remitters. Personally, I'm biased to not believing of pain remitters, but one of the definitions were if the VASCOR was less than 2.5. It's a big debate among multiple pain specialty. I would say that I'm presenting those slides. I'm not a big believer of pain remitters, but I'm really a big believer that if you really drop over 80% relief, that is put you a little bit more towards the semi-normal category of patients. So we have seen with that newer technology and other newer technology with neuromodulation, people drop their VASCOR below 2.5. In the history of doing pain management, which is not a long history, I've been doing that for about 11 years, I've not seen a lot of people that drop that much. So I'm just presenting this data for this study. As you can see in this slide, we have a couple of pain remitters in the neck pain population and upper limb population. The disability access, the pain disability index was also measured. And if you can see, there was at 12 months, those 15 subjects dropped about 24.3 points in the pain disability index. Coming into conclusion, it's a promising therapy. It is the first therapy that, it's the first trial that we've seen high frequency stimulated directed to chronic axial neck pain. And up until now, the data is supportive for using that particular technology or particular frequency. And we have seen a response rate of above 75% disability reduction of about 24.3 on the PDI. None of the subjects felt paracesia. All the subjects were allowed to drive, which is something that is not on label on the non-paracesia free stimulators, which we think about is a good thing because especially if it's upper limb pain, some people who suffer from paracesia are not allowed to do a lot of activities including driving. With that, I would leave you with the results of this trial, hoping that in NANS of 2019, we'd see the full result of this trial and also will inaugurate a bigger randomized controlled trial for axial neck pain. These are pictures of all the PIs in different sites that were in that trial. Thank you so much for having me today.

spinal cord stimulation

chronic pain treatment

SENZA system

FDA approved device

pain relief