High Frequency Spinal Cord Stimulation Research Articles

Non-responders to high frequency spinal cord stimulation.

Non-responders to high frequency spinal cord stimulation.

ID: 321468 Quantitative Assessment of Painful Diabetic Peripheral Neuropathy (PDN) after High Frequency Spinal Cord Stimulation (SCS)

ID: 321468 Quantitative Assessment of Painful Diabetic Peripheral Neuropathy (PDN) after High Frequency Spinal Cord Stimulation (SCS)

ID: 341419 A Multi-Center Real-World European Experience of Treating Painful Diabetic Neuropathy with High-Frequency Spinal Cord Stimulation

ID: 341419 A Multi-Center Real-World European Experience of Treating Painful Diabetic Neuropathy with High-Frequency Spinal Cord Stimulation

ID: 321718 Log Term Durability Of High-Frequency Spinal Cord Stimulation For Chronic Pain In Australia

ID: 321718 Log Term Durability Of High-Frequency Spinal Cord Stimulation For Chronic Pain In Australia

346 Durable Responses at 24 Months With High-Frequency Spinal Cord Stimulation for Nonsurgical Refractory Back Pain

INTRODUCTION: Chronic refractory back pain causes significant disability and is one of the most common reasons for patients seeking health care. Few treatment options exist for chronic back pain patients who have failed conventional medical management (CMM) and who have not had and are not candidates for spine surgery, a condition we refer to as non-surgical refractory back pain (NSRBP). METHODS: Patients with NSRBP were evaluated after 1:1 randomization to 10kHz SCS plus CMM or CMM alone. Primary endpoint and secondary endpoints were assessed, and optional crossover was allowed at 6 months, with observational follow-up over 12 months (Kapural, 2022). All patients treated with 10kHz SCS were eligible for follow-up through 24 months after implantation. Outcomes included pain, Oswestry Disability Index (ODI), quality-of-life (EQ-5D-5L), 3-item Pain Sleep Questionnaire (PSQ-3), opioid use, patient’s global impression of change (PGIC), and safety. RESULTS: Of the 125 patients who received a permanent implant, 121 completed 12-month follow-up, 101 reconsented for extended follow-up, and 98 completed 24-month follow-up. At 24 months after implantation 82% achieved =50% pain relief. All outcome measures improved by at least double the minimal clinically important difference. Ninety-percent of patients met at least one of the multidimensional outcomes. Of those who reported opioid use during the study, and 62% of decreased or stopped. Through 24 months, 3 of 125 (2.4%) devices were explanted due to patient dissatisfaction with SCS therapy. CONCLUSIONS: The addition of 10kHz SCS to CMM in patients with NSRBP offers profound improvements at 24 months in pain, function, quality-of-life, and reduced opioid use. This study provides much-needed evidence to inform current clinical practice for managing patients with NSRBP.

894 Comparison of Intraoperative Neural Changes During Tonic Versus High-Frequency Spinal Cord Stimulation in Chronic Pain Patients

INTRODUCTION: Chronic pain is a prevalent issue that may affect up to 34% of US adults, and spinal cord stimulation (SCS) is a promising therapy. However, SCS device selection remains a challenge because there are currently no objective biomarkers to evaluate chronic pain, or to predict which patients will be responders. METHODS: Intraoperative EEG signals were recorded in 24 chronic pain patients (14 women) during permanent SCS electrode placement surgery. Neural responses were captured with respect to tonic (60 Hz/300 µs) and high-frequency (1 kHz/30 µs) SCS paradigms in a randomized manner and correlated to Numeric Rating Scale (NRS) scores. All data were analyzed offline in MATLAB and SPSS v28.0.1.1. RESULTS: Our analyses for the main effects demonstrated a significant difference between cortical regions (F(2.88,57.7) = 7.60 , p < 0.001) and a marginal difference between stimulation conditions (F(2,40) = 2.970, p = 0.063). The post hoc analysis for these factors revealed that alpha/theta peak power ratio was significantly different between in central regions (C3-C4) between tonic and HF stimulation (p = 0.006) and temporal regions (T3-T4) between baseline and HF stimulation (p = 0.049). The comparison of NRS scores before and 3 months after surgery indicated a significant improvement in pain intensity (p < 0.001) at the group level. The neural features found to be significantly correlated with preoperative NRS scores in PFC (p = 0.036 and p = 0.025) and temporal regions (p = 0.041 and p = 0.012) under both stimulations. CONCLUSIONS: Our preliminary results support the possibility that different stimulation patterns affect the electrophysiological activity differently in various cortical regions. Such differences might account for the variability in pain suppression in patients with chronic pain treated with SCS. Future work will utilize this dataset to develop a machine learning classifier to support objective device selection strategies.

Healthcare Utilization (HCU) Reduction with High-Frequency (10 kHz) Spinal Cord Stimulation (SCS) Therapy.

Spinal cord stimulation (SCS) is a well-established treatment for patients with chronic pain. With increasing healthcare costs, it is important to determine the benefits of SCS in healthcare utilization (HCU). This retrospective, single-center observational study involved 160 subjects who underwent implantation of a high-frequency (10 kHz) SCS device. We focused on assessing trends in HCU by measuring opioid consumption in morphine milligram equivalents (MME), as well as monitoring emergency department (ED) and office visits for interventional pain procedures during the 12-month period preceding and following the SCS implant. Our results revealed a statistically significant reduction in HCU in all domains assessed. The mean MME was 51.05 and 26.52 pre- and post-implant, respectively. There was a 24.53 MME overall decrease and a mean of 78.2% statistically significant dose reduction (p < 0.0001). Of these, 91.5% reached a minimally clinically important difference (MCID) in opioid reduction. Similarly, we found a statistically significant (p < 0.01) decrease in ED visits, with a mean of 0.12 pre- and 0.03 post-implant, and a decrease in office visits for interventional pain procedures from a 1.39 pre- to 0.28 post-10 kHz SCS implant, representing a 1.11 statistically significant (p < 0.0001) mean reduction. Our study reports the largest cohort of real-world data published to date analyzing HCU trends with 10 kHz SCS for multiple pain etiologies. Furthermore, this is the first and only study evaluating HCU trends with 10 kHz SCS by assessing opioid use, ED visits, and outpatient visits for interventional pain procedures collectively. Preceding studies have individually investigated these outcomes, consistently yielding positive results comparable to our findings.

A single-center real-world review of 10 kHz high-frequency spinal cord stimulation outcomes for treatment of chronic pain

ObjectiveTo compare pragmatic real-world 10-kHz high-frequency spinal cord stimulation (HF-SCS) outcomes at a single academic center to the industry-sponsored SENZA-RCT and Stauss et al. study. MethodsThis single-center retrospective study included patients with refractory back or limb pain trialed and/or permanently implanted with the Nevro HF-SCS system from 2016 to 2021. Demographic and outcome data were obtained from the electronic medical record (EMR) and real-world global database maintained by Nevro Corp. Data obtained from the global database were confirmed using the EMR. Main outcome measures included positive responder status (≥50% patient-reported percentage pain reduction (PRPPR)), improvement in function, improvement in sleep, and reduction in pain medication usage. Comparison groups included patient outcomes from the SENZA-RCT and Stauss et al. study. ResultsPatients (N = 147) trialed with HF-SCS were reviewed, with data available for 137. Positive trialed patient responder rate (≥50% PRPPR) was 77% (106/137, 95CI 70–84%) vs. 87% (1393/1607, 95CI 85–89%) Stauss et al. vs. 93% (90/97, 95CI 88–98%) SENZA-RCT HF-SCS. At the last available follow-up, positive implanted patient responder rate was 73% (58/80, 95CI 63–82%) vs. 78% (254/326, 95CI 73–82%) Stauss et al. vs. 79% (71/90, 95CI 70–87%) SENZA-RCT HF-SCS. Sixty-seven percent (59/88, 95CI 57–77%) reported improved function vs. 72% (787/1088, 95CI 70–75%) Stauss et al.; 45% (31/69, 95CI 33–57%) reported improved sleep vs. 68% (693/1020, 95CI 65–71%) Stauss et al. and 16% (9/56, 95CI 6–26%) reported decrease in medication use vs. 32% (342/1070, 95CI 29–35%) Stauss et al. ConclusionPatient responder rates in this retrospective pragmatic real-world study of HF-SCS are consistent with previous industry-sponsored studies. However, improvements in quality-of-life measures and reduction in medication usage were not as robust as reported in industry-sponsored studies. The findings of this non-industry-sponsored, independent study of HF-SCS complement those of previously published studies by reporting patient outcomes collected in the absence of industry sponsorship.

Conventional management and current guidelines for painful diabetic neuropathy

Painful Diabetic Peripheral Neuropathy (PDN) is common, affecting around a quarter of patients with both type 1 and type 2 diabetes, and can lead to significant curtailment of functionality and quality of life. Patients may present with unremitting burning, aching or “electric-shock” type pains in their feet, legs and later, in the hands. Conventional management approaches must focus not only on pain relief, but also on concurrent sleep problems, mood disorders and functionality. The mainstay of treatment is pharmacotherapy. Most current international guidelines recommend a choice of four drugs: amitriptyline, duloxetine, pregabalin or gabapentin, as initial treatment for PDN. Recent evidence from the OPTION-DM trial demonstrated that these drugs and their combinations have equivalent efficacy. Moreover, combination treatment provided significant pain relief to patients with inadequate response to the maximum tolerated dose of monotherapy. PDN refractory to pharmacotherapy can be treated with capsaicin 8% or high frequency spinal cord stimulation.

Real world outcomes with spinal cord stimulation

High frequency spinal cord stimulation (SCS) is a safe and effective treatment option for refractory painful diabetic neuropathy and should be considered for use early in the course of the disease. Raising awareness of this minimally invasive treatment option among physician networks is of major importance.

1809-PUB: Painful Diabetic Neuropathy—Patients Treated with High-Frequency (10 kHz) Spinal Cord Stimulation (SCS) Experience Significant Reductions in A1C and Weight

Objective: Up to 9 million Americans have painful diabetic neuropathy (PDN), which can be debilitating. For PDN patients, 10 kHz SCS has been shown to provide mean pain relief of 77% at 24 months (24M), and here we report secondary, novel potential benefits for A1C and body weight. Methods: Subjects received a 10 kHz SCS implant plus medical management for their pain and diabetes. Subjects were followed for 24M post-implantation. Key inclusion criteria were: PDN ≥12M refractory to medications, lower limb pain ≥5cm (10cm VAS), and A1C ≤10%. For T2D subjects, changes in weight were evaluated for all subjects and cohorts with pre-implant BMI ≥30 and ≥35, and changes in A1C were evaluated for cohorts with pre-implant A1C ≥7.0% and ≥8.0%. Results: For cohorts evaluated, A1C and weight generally decreased with time (Fig. 1). For subjects with pre-implant A1C ≥8.0%, the mean A1C reduction was 0.52% at 6M (p=0.064) and 1.04% at 24M (p=0.007). For all subjects, the mean weight reduction was 1.8 kg at 12M (p=0.058) and 3.1 kg at 24M (p=0.003). For subjects with pre-implant BMI ≥35, the mean weight reduction was 5.4 kg at 24M (p=0.005). Conclusions: Previously reported pain relief and sensory improvement, coupled with reductions in A1C and weight reported here, further demonstrate the benefits of 10 kHz SCS treatment in the comprehensive care of T2D patients with PDN. Disclosure D.C.Klonoff: Consultant; EOFlow Co., Ltd., Fractyl Health, Inc., Integrity, Lifecare, Inc., Rockley Photonics, Thirdwayv Inc. B.L.Levy: Advisory Panel; Nevro Corp., CeQur SA, Consultant; Nevro Corp., CeQur SA, Digma Medical. M.Jaasma: Consultant; Bone Health Technologies, Inc., Employee; Nevro Corp., Bone Health Technologies, Inc. M.Bharara: Employee; Nevro Corp. C.E.Nasr: Advisory Panel; Siemens, Horizon Therapeutics plc. D.L.Caraway: Employee; Nevro Corp. E.Petersen: Consultant; Abbott, Biotronik, Medtronic, Nalu, Nevro Corp., Presidio Medical, Saluda Medical, Vertos Medical Inc., Research Support; Nalu, Nevro Corp. D.G.Armstrong: Research Support; Medaxis LLC. Funding Nevro Corp.

ID: 222114 Effects of High Frequency Spinal Cord Stimulation as Measured by Autonomic Tone and fMRI

We investigated high frequency spinal cord stimulation (HF-SCS) efficacy in 1) reducing autonomic output as measured by galvanic skin response (GSR) levels during anticipation of and exposure to noxious thermal stimuli in while undergoing functional magnetic resonance imaging of the brain, and 2) altering subjective experience of pain as measured by the Short Form McGill Pain Questionnaire (SF-MPQ-2) and a modified Brief Pain Inventory Short Form (BPI-SF).

ID: 217111 Use of High Frequency Spinal Cord Stimulation to Treat Monoclonal Antibody Induced Neuropathy: Case Report

The use of spinal cord stimulators (SCS) in the treatment of painful diabetic peripheral neuropathy is well-described in medical literature1,2. However, the efficacy of SCS to treat other peripheral neuropathic pain states is not well described. In this case study, we report the use of a high frequency SCS system to treat monoclonal antibody-induced peripheral neuropathy.

ID: 216535 Ten-Year Real-World Data on the Efficacy of High-Frequency 10 kHz Spinal Cord Stimulation

The efficacy of high frequency spinal cord stimulation (10 kHz SCS) for the treatment of chronic trunk and or limb pain has been demonstrated by the SENZA-RCT1 study. Real world data with a 12-month follow-up additionally support the efficacy of 10kHz SCS2. Previous work also demonstrated long-term durability of 10 kHz SCS and clinically meaningful results for patients with chronic lower back and or leg pain at 24 months (SENZA-EU)3. Here we present 10-year follow-up data on patients who originally participated in the SENZA-EU study3 and continued with usual care in a real-world setting over a mean period of 10 years.

ID: 216388 Treatment of Post-Surgical Pain Following Mastectomy With 10 kHz Spinal Cord Stimulation: A Case Study

Post-surgical pain (PSP) following mastectomy is often neuropathic1 and focally located around the chest wall, armpit and or arm2. High-frequency spinal cord stimulation (10kHz SCS) could potentially be used as a treatment option for this indication as pre-clinical evidence for 10kHz SCS demonstrates an inhibitory effect of interneurons in the dorsal horn providing a useful mechanism of action (MOA) for paresthesia-free neuropathic pain relief3. Here we present a case study detailing the successful use of 10kHz SCS in the treatment of PSP following mastectomy.

ID: 216095 High-Frequency Spinal Cord Stimulation (SCS) in Patients Converted From Traditional SCS: A Case Series

Spinal cord stimulation (SCS) is an evidence-based intervention for treating chronic neuropathic pain1. However, with traditional SCS, around 30% of patients may require explant for reasons including loss of efficacy during treatment2. High-frequency SCS (10kHz SCS) has been reported to demonstrate long-term superiority compared to traditional low-frequency (LF) SCS3. Furthermore, converting from LF to 10kHz SCS can restore pain relief in patients experiencing loss of efficacy4. In this study, we present a case series of 6 patients converted from LF SCS to 10kHz therapy due to loss of efficacy.

ID: 220244 A Single-Center Review of 10 kHz Spinal Cord Stimulator Treatment Outcomes for Chronic Pain

Chronic pain is a prevalent worldwide condition, leading to diminished quality of life and workforce productivity (1). First-line therapies from conservative medical management to surgery have demonstrated varying degrees of efficacy, though sustained long-term pain management remains a challenge (2). Low-frequency spinal cord stimulation (LF-SCS) has been used in a subset of patients as a cost-effective and minimally invasive therapy to achieve pain control and improved quality of life (3). However, its limitations include diminished long-term relief, uncomfortable paresthesia, and incomplete pain control (4). The pivotal SENZA-RCT in 2015 demonstrated the efficacy of 10 kHz (high-frequency) spinal cord stimulation (HF-SCS) as a superior alternative to LF-SCS (5). The study, although promising, was industry-sponsored and potentially vulnerable to bias including withholding of negative data or exaggeration of beneficial effects. The goal of this single-center retrospective review was to compare outcomes of real-world/pragmatic HF-SCS pain outcomes to previously published studies without the potential bias of industry funding.

ID: 216418 Activation of Inhibitory Circuit in Reflex Motor Pathways by 10kHz Versus Single Pulse/Low Frequency SCS

High frequency (10kHz) spinal cord stimulation (SCS) is a well-established and expanding neuromodulatory technique for treating chronic pain. Despite clinical success, the cellular mechanisms of 10kHz SCS for activating neurons is still not fully understood. In previous preclinical work, we reported that 10kHz SCS activated the thigh muscle selectively, with very little activation by single pulse (low frequency) SCS. The toe muscle showed a similar but opposite selectivity, where single pulse/low frequency SCS resulted in more selective activation of the toe than 10kHzSCS. In the literature, both animal and human studies reported that use of a paired pulse protocol generates recurrent, presynaptic inhibition and homosynaptic depression depending on the delay between first and second pulses. Here we studied the activation of inhibitory circuits in reflex motor pathways using a paired pulse protocol of 10 kHz SCS vs. low frequency/single pulse SCS.

ID: 200637 10 kHz SCS Provides Durable Pain Relief for Patients With Painful Diabetic Neuropathy

Approximately 37 million Americans have diabetes,1 with ∼25% experiencing painful diabetic neuropathy (PDN).2 Unfortunately, conventional medical management (CMM), which includes pharmacotherapies, is largely ineffective for many patients.2 High-frequency (10 kHz) spinal cord stimulation (SCS) has been shown to provide substantial symptom relief for PDN,3 and here we report durability of outcomes to 24 months (24M).

ID: 216932 High-Frequency Spinal Cord Stimulation Salvages Therapy in Failed Low-Frequency Treatment of Failed Back Surgery Syndrome

Spinal cord stimulator (SCS) is a Federal Drug Administration-approved treatment modality for treating failed back surgery syndrome (FBSS), complex regional pain syndrome (CRPS), and diabetic neuropathy (DN). Patients first must undergo an SCS trial by placing electrodes in the epidural space with a temporary external power source to determine if the patient achieves pain relief. The pulses generated by the SCS create paresthesias to interfere with the pain. If the trial is successful, a permanent SCS is implanted. Despite using paresthesias in low-frequency SCS treatment, many patients find this uncomfortable. To avoid using paresthesias with low frequency, a newer, higher frequency version using a waveform of 10 kHz at a subthreshold level can provide superior pain relief without paresthesias. Additionally, high-frequency SCS may be used to salvage therapy where low-frequency SCS has failed. Here, we present a case where we switched mid-trial from low-frequency to high-frequency SCS with lead placement revision salvaging the trial and improving the patient’s overall pain.