Burst Spinal Cord Stimulation Research Articles

Surgical treatment of refractory low back pain using implanted BurstDR spinal cord stimulation (SCS) in a cohort of patients without options for corrective surgery: Findings and results from the DISTINCT study, a prospective randomized multi-center-controlled trial

Background: Low back pain (LBP) is a highly prevalent, disabling condition affecting millions of people. Patients with an identifiable anatomic pain generator and resulting neuropathic lower extremity symptoms often undergo spine surgery, but many patients lack identifiable and/or surgically corrective pathology. Nonoperative treatment options often fail to provide sustained relief. Spinal cord stimulation (SCS) is sometimes used to treat these patients, but the lack of level 1 evidence limits its widespread use and insurance coverage. The DISTINCT RCT study evaluates the efficacy of passive recharge burst SCS compared to conventional medical treatment (CMM) in alleviating chronic, refractory axial low back pain. MethodsThis prospective, multicenter, randomized, study with an optional 6-month crossover involved patients who were not candidates for lumbar spine surgery. The primary and secondary endpoints evaluated improvements in low back pain intensity (NRS), back pain-related disability (ODI), pain catastrophizing (PCS), and healthcare utilization. Patients were randomized to SCS therapy or CMM at 30 US study sites. ResultsThe SCS arm reported a 85.3% NRS responder rate (≥ 50% reduction) compared to 6.2% (5/81) in the CMM arm. After the 6M primary endpoint, SCS patients elected to remain on assigned therapy and 66.2% (49/74) of CMM patients chose to trial SCS (crossover). At the 12M follow-up, SCS and crossover patients reported 78.6% and 71.4% NRS responder rates. Secondary outcomes indicated significant improvements in ODI, PCS, and reduced healthcare utilization. Six serious adverse events were reported and resolved without sequelae. ConclusionDISTINCT chronic low back pain patients with no indication for corrective surgery experienced a significant and sustained response to burst SCS therapy for up to 12 months. CMM patients who crossed over to the SCS arm reported profound improvements after 6 months. This data advocates for a timely consideration of SCS therapy in patients unresponsive to conservative therapy.

350 Surgical Treatment of Refractory Low Back Pain Using BurstDR Capable Spinal Cord Stimulation (SCS) in Patients Without Options for Corrective Surgery; 12-month Results From a Paddle Lead Cohort

INTRODUCTION: DISTINCT is a randomized controlled trial evaluating passive recharge burst SCS compared to CMM in improving pain and pain-related physical function in patients suffering from chronic back pain without prior lumbar surgery, and for whom corrective surgery is not an option. Sub analysis of outcome measures are presented for subjects implanted with paddle leads at both 6 and 12 months. METHODS: An independent board-certified spine surgeon reviewed each case confirming a lack of corrective surgical options. Out of 29 sites and 115 implants, 10 sites implanted 50 subjects with paddle leads. Primary and secondary endpoints assessed improvements in low back pain intensity (NRS), low back pain-related disability (ODI), pain catastrophizing (PCS), and patient global impression of change (PGIC). RESULTS: Data are available for 47 and 44 subjects at 6 and 12 months respectively. Subjects reported significant reductions in pain relief at 6 and 12 months, decreasing from 7.8 ± 1.2 at baseline to 2.0 ± 1.6 and 2.2 ± 2.2 respectively (p < 0.0001). Disability was substantially (< 20 points) reduced from severe to mild at 6 and 12 months; ODI reduced from 54.4 ± 15.0 at baseline to 19.9 ± 14.1 and 22.1 ± 13.6 respectively (p < 0.0001). Pain catastrophizing improved to reflect the average of a non-chronic pain population; decreased from 27.6 ± 13.1 at baseline to 8.1 ± 8.2 and 7.8 ± 9.9 (p < 0.0001). 76% report definite and meaningful improvements on PGIC. One lead related event was reported and resolved by repositioning CONCLUSIONS: Passive recharge bursts using paddle leads provide substantial relief to patients suffering from severe, debilitating, NSLBP. Patients report dramatic improvements in pain, function, and pain-related emotional distress. In addition, the rate of adverse events is low supporting a favorable safety profile.

Prospective Six-Month Analysis of Multiarea Burst Spinal Cord Stimulation: Correlating Intraoperative Neuromonitoring With Postoperative Programming and Clinical Outcomes

IntroductionDeRidder burst spinal cord stimulation (SCS) has shown superior relief from overall pain to traditional tonic neurostimulation therapies and a reduction in back and leg pain. However, nearly 80% of patients have two or more noncontiguous pain areas. This affects the ability to effectively program stimulation and deliver long-term efficacy of the therapy. Multiple DeRidder burst region programming is an option to treat multisite pain by interleaving stimulation at multiple areas along the spinal cord. Previous intraoperative neuromonitoring studies have shown that DeRidder burst stimulation provides broader myotomal coverage at a lower recruitment threshold. The goal of this study is to correlate intraoperative electromyogram (EMG) threshold and postsynaptic excitability with postoperative paresthesia thresholds and optimal burst stimulation programming. Materials and MethodsNeuromonitoring was performed during permanent implant of SCS leads in ten patients diagnosed with chronic intractable back and/or leg pain. Each patient underwent the surgical placement of a Penta Paddle electrode through laminectomy at the T8–T11 spinal levels. Subdermal electrode needles were placed into lower extremity muscle groups, in addition to the rectus abdominis muscles, for EMG recording. Evoked responses were compared across multiple trials of burst stimulation in which the number of independent burst areas was varied. After intraoperative data collection, all patients were programmed with single- and multiarea DeRidder burst. Intermittent dosing was delivered at 30:90, 120:360, 120:720, and 120:1440 (seconds ON/OFF) intervals. Numerical rating scale (NRS) and Patient Global Impression of Change scores were evaluated at one, two, three, four, and six months after permanent implant. ResultsThe thresholds for EMG recruitment after DeRidder burst differed across all patients owing to anatomical and physiological variations. After a 30-second dose of stimulation, the average decrease in thresholds was 1.25 mA for two-area and 0.9 mA for four-area DeRidder burst. Furthermore, a 30-second dose of multisite DeRidder burst produced a 0.25 mA reduction in the postoperative paresthesia thresholds. Across all patients, the baseline NRS score was 6.5 ± 0.5, and the NRS score after single or multiarea DeRidder burst therapy was 2.87 ± 1.50. Eight of ten patients reported a ≥50% decrease in their pain scores through the six-month follow-up visit. Pain outcomes using intermittent multiarea stimulation with longer OFF times (120:360, 120:720, 120:1440) were comparable to those using single-area DeRidder burst at 30:90 up to six months after implant with patient preference being two-area DeRidder burst. ConclusionsThis study aims to evaluate the use of intraoperative neuromonitoring to optimize stimulation programming for multisite pain and correlate it with postoperative programming and efficacy. These results suggest that multisite programming can be used to further customize DeRidder burst stimulation to each individual patient and improve outcomes and quality of life for patients receiving SCS therapy for multisite pain.

BurstDR spinal cord stimulation rebalances pain input and pain suppression in the brain in chronic neuropathic pain

ObjectiveChronic pain is processed by at least three well-known pathways, two pain provoking pathways including a medial ‘suffering’ and lateral ‘painfulness’ pathway. A third descending pain pathway modulates pain but is predominantly inhibitory. Chronic pain can be seen as an imbalance between the two pain-provoking and the pain inhibitory pathways. If this assumption is correct, then the imbalance between pain input and pain suppression should reverse and normalize in response to successful, i.e., pain reducing burstDR spinal cord stimulation, one of the current treatment options for neuropathic pain. Materials and methodsFifteen patients, who received spinal cord stimulation for failed back surgery were included in this study, using source localized electrical brain activity and connectivity recording via EEG to identify the purported imbalance. ResultsBurstDR spinal cord stimulation induces a significant change in EEG activity in both the left and right somatosensory cortex (SSC) for both θ and γ oscillations. In the dorsal anterior cingulate cortex (dACC), we observed a significant drop in both α and β oscillations. This reduction is accompanied by a change in pain intensity and suffering. BurstDR spinal cord stimulation is also associated with a reduction in θ at the pregenual anterior cingulate cortex (pgACC). Analyzing effective connectivity indicates that for the θ band, more information is sent from the pgACC to the left and right SSC. For α, increased information is sent from the pgACC to the dACC and both the left and right SSC. This is associated with a reduced θ-γ coupling in the SSC and reduced α-β coupling in dACC. ConclusionThis study suggests that chronic pain is indeed an imbalance between the ascending and descending pathways in the brain and that burst spinal cord stimulation can normalize this imbalance in the brain.

ID: 200986 Quantifying Differential Neural Activation With Burst and Conventional Stimulation Using Spinal Evoked Compound Action Potentials

Unlike conventional spinal cord stimulation (SCS)—which employs single pulses delivered at a fixed rate to the dorsal spinal cord—burst SCS uses a fixed rate, five-pulse burst of stimuli as a treatment for chronic pain. Mechanistically, burst SCS is thought to mimic the natural firing rhythm of the nervous system, resulting in the differential modulation of the affective component of pain processing via the medial pain pathway versus conventional SCS. Differences in neural activation resulting from either burst or conventional SCS may be quantified with the spinal evoked compound action potential (ECAP), an electrical measure of synchronous neural activation. Here, we use ECAPs in sheep to assess these differences and gain mechanistic insight into both types of SCS.

ID: 214525 Utilizing intraoperative EMG and Post-Operative Paresthesia Thresholds to Quantify Post-Synaptic Excitability Following Burst SCS

Burst spinal cord stimulation (SCS) has demonstrated superior relief from overall pain and a reduction in back and leg pain compared to traditional tonic neurostimulation therapies. However, nearly 80% of patients have 2 or more non-contiguous pain areas. This can affect the ability to effectively program stimulation and the long-term efficacy of therapy. Multiple BurstDR region programming is a new option to treat multi-site pain by interleaving stimulation at multiple areas along the spinal cord. Prior intraoperative studies have shown that BurstDR stimulation provides broader myotomal coverage at a lower recruitment threshold. The overall goal of this study is to use changes in intraoperative EMG threshold and post-operative paresthesia thresholds to optimize burst stimulation programming.

Burst Spinal Cord Stimulation as Compared With L2 Dorsal Root Ganglion Stimulation in Pain Relief for Nonoperated Discogenic Low Back Pain: Analysis of Two Prospective Studies

IntroductionChronic discogenic low back pain (CD-LBP) is caused by degenerated disks marked by neural and vascular ingrowth. Spinal cord stimulation (SCS) has been shown to be effective for pain relief in patients who are not responsive to conventional treatments. Previously, the pain-relieving effect of two variations of SCS has been evaluated in CD-LBP: Burst SCS and L2 dorsal root ganglion stimulation (DRGS). The aim of this study is to compare the effectivity in pain relief and pain experience of Burst SCS with that of conventional L2 DRGS in patients with CD-LBP. Materials and MethodsSubjects were implanted with either Burst SCS (n = 14) or L2 DRGS with conventional stimulation (n = 15). Patients completed the numeric pain rating score (NRS) for back pain and Oswestry disability index (ODI) and EuroQoL 5D (EQ-5D) questionnaires at baseline, and at three, six, and 12 months after implantation. Data were compared between time points and between groups. ResultsBoth Burst SCS and L2 DRGS significantly decreased NRS, ODI, and EQ-5D scores as compared with baseline. L2 DRGS resulted in significantly lower NRS scores at 12 months and significantly increased EQ-5D scores at six and 12 months. ConclusionsBoth L2 DRGS and Burst SCS resulted in reduction of pain and disability, and increased quality of life in patients with CD-LBP. L2 DRGS provided significantly increased pain relief and improvement in quality of life when compared with Burst SCS. Clinical Trial RegistrationThe clinical trial registration numbers for the study are NCT03958604 and NL54405.091.15.

Painful Peripheral Neuropathies of the Lower Limbs and/or Lower Extremities Treated with Spinal Cord Stimulation: A Systematic Review with Narrative Synthesis.

Painful peripheral neuropathy (PPN) is a debilitating condition with varied etiologies. Spinal cord stimulation (SCS) is increasingly used when conservative treatments fail to provide adequate pain relief. Few published reviews have examined SCS outcomes in all forms of PPN. We conducted a systematic review of SCS in PPN. The PubMed database was searched up to February 7th, 2022, for peer-reviewed studies of SCS that enrolled PPN patients with pain symptoms in their lower limbs and/or lower extremities. We assessed the quality of randomized controlled trial (RCT) evidence using the Cochrane risk of bias tool. Data were tabulated and presented narratively. Twenty eligible studies documented SCS treatment in PPN patients, including 10 kHz SCS, traditional low-frequency SCS (t-SCS), dorsal root ganglion stimulation (DRGS), and burst SCS. In total, 451 patients received a permanent implant (10 kHz SCS, n=267; t-SCS, n=147; DRGS, n=25; burst SCS, n=12). Approximately 88% of implanted patients had painful diabetic neuropathy (PDN). Overall, we found clinically meaningful pain relief (≥30%) with all SCS modalities. Among the studies, RCTs supported the use of 10 kHz SCS and t-SCS to treat PDN, with 10 kHz SCS providing a higher reduction in pain (76%) than t-SCS (38-55%). Pain relief with 10 kHz SCS and DRGS in other PPN etiologies ranged from 42-81%. In addition, 66-71% of PDN patients and 38% of nondiabetic PPN patients experienced neurological improvement with 10 kHz SCS. Our review found clinically meaningful pain relief in PPN patients after SCS treatment. RCT evidence supported the use of 10 kHz SCS and t-SCS in the diabetic neuropathy subpopulation, with more robust pain relief evident with 10 kHz SCS. Outcomes in other PPN etiologies were also promising for 10 kHz SCS. In addition, a majority of PDN patients experienced neurological improvement with 10 kHz SCS, as did a notable subset of nondiabetic PPN patients.

The Effectiveness of Various Types of Electrical Stimulation of the Spinal Cord for Chronic Pain in Patients with Postherpetic Neuralgia: A Literature Review.

Postherpetic neuralgia (PHN) is a severe condition that remains a challenge to treat. Spinal cord stimulation (SCS) is used in cases of insufficient efficacy of conservative treatment. However, in contrast to many other neuropathic pain syndromes, there is a huge problem in reaching long-term stable pain relief in patients with PHN using conventional tonic SCS. The objective of this article was to present a review of the current management strategies of PHN, their efficacy, and safety. We searched for articles containing the keywords "spinal cord stimulation AND postherpetic neuralgia," "high-frequency stimulation AND postherpetic neuralgia," "burst stimulation AND postherpetic neuralgia" and "dorsal root ganglion stimulation AND postherpetic neuralgia" in Pubmed, Web of Science, and Scopus databases. The search was limited to human studies published in the English language. There were no publication period limitations. Bibliographies and references of selected publications on neurostimulation for PHN were further manually screened. The full text of each article was studied once the abstract was analyzed by the searching reviewer and found appropriate. The initial search yielded 115 articles. Initial screening based on abstract and title allowed us to exclude 29 articles (letters, editorials, and conference abstracts). The full-text analysis allowed us to exclude another 74 articles (fundamental research articles, research utilizing animal subjects, and systemic and nonsystemic reviews) and results of PHN treatment presented with other conditions, leaving 12 articles for the final bibliography. 12 articles reporting on the treatment of 134 patients with PHN were analyzed, with a disproportionally large amount of traditional SCS treatment than that to alternative SCS: DRGS (13 patients), burst SCS (1 patient), and high-frequency SCS (2 patients). Long-term pain relief was achieved in 91 patients (67.9%). The mean VAS score improvement was 61.4% with a mean follow-up time of 12.85 months. Although the number of patients in alternative SCS studies was very limited, almost all of them showed good responses to therapy with more than 50% VAS improvement and reduction of analgesic dosage. The article contains a review analysis of 12 articles concerning the current methods of treatment for postherpetic neuralgia including conservative treatment, spinal cord stimulation, and novel neuromodulation strategies. Available information on the pathophysiology of PHN and the effect or stimulation on its course, together with a number of technical nuances concerning various types of neurostimulation are also elucidated in this article. A number of alternative invasive treatments of PHN are also discussed. Spinal cord stimulation is an established treatment option for patients with pharmacologically resistant PHN. High-frequency stimulation, burst stimulation, and dorsal root ganglion stimulation are promising options in the management of PHN due to the absence of paresthesias which can be painful for patients with PHN. But more research is still required to recommend the widespread use of these new methods.

Narrative review of current neuromodulation modalities for spinal cord injury.

Neuromodulation is a developing field of medicine that includes a vast array of minimally invasive and non-invasive therapies including transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), vagus nerve stimulation (VNS), peripheral nerve stimulation, and spinal cord stimulation (SCS). Although the current literature surrounding the use of neuromodulation in managing chronic pain is abundant, there is an insufficient amount of evidence specifically regarding neuromodulation in patients with spinal cord injury (SCI). Given the pain and functional deficits that these patients face, that are not amenable to other forms conservative therapy, the purpose of this narrative review is to examine and assess the use of various neuromodulation modalities to manage pain and restore function in the SCI population. Currently, high-frequency spinal cord stimulation (HF-SCS) and burst spinal cord stimulation (B-SCS) have been shown to have the most promising effect in improving pain intensity and frequency. Additionally, dorsal root ganglion stimulation (DRG-S) and TMS have been shown to effectively increase motor responses and improve limb strength. Although these modalities carry the potential to enhance overall functionality and improve a patient's degree of disability, there is a lack of long-term, randomized-controlled trials in the current space. Additional research is warranted to further support the clinical use of these emerging modalities to provide improved pain management, increased level of function, and ultimately an overall better quality of life in the SCI population.

Regional Coverage Differences With Single- and Multi-Area Burst Spinal Cord Stimulation for Treatment of Chronic Pain

IntroductionBurst spinal cord stimulation (SCS) has shown superior relief from overall pain and a reduction in back and leg pain compared with traditional tonic neurostimulation therapies. However, nearly 80% of patients have two or more noncontiguous pain areas. This can provide challenges in effectively programming stimulation and long-term therapy efficacy. Multiarea DeRidder Burst programming is a new option to treat multisite pain by delivering stimulation to multiple areas along the spinal cord. This study aimed to identify the effect of intraburst frequency, multiarea stimulation, and location of DeRidder Burst on the evoked electromyography (EMG) responses. Materials and MethodsNeuromonitoring was performed during permanent implant of SCS leads in nine patients diagnosed with chronic intractable back and/or leg pain. Each patient underwent the surgical placement of a Penta Paddle electrode via laminectomy at the T8–T10 spinal levels. Subdermal electrode needles were placed into lower extremity muscle groups, in addition to the rectus abdominis muscles, for EMG recording. Evoked responses were compared across multiple trials of burst stimulation in which the number of independent burst areas were varied. ResultsThe thresholds for EMG recruitment with DeRidder Burst differed across patients owing to anatomic and physiological variations. The average threshold to evoke a bilateral EMG response using single site DeRidder Burst was 3.2 mA. Multisite DeRidder Burst stimulation on up to four stimulation programs evoked a bilateral EMG response at a threshold of 2.5 mA (∼23% lower threshold). DeRidder Burst stimulation across four electrode pairs resulted in more proximal recruitment (vastus medialis and tibialis anterior) than did stimulation across two pairs. It also resulted in more focal coverage of areas across multiple sites. ConclusionsAcross all patients, multisite DeRidder Burst provided broader myotomal coverage than did traditional DeRidder Burst. Multisite DeRidder Burst stimulation provided focal recruitment and differential control of noncontiguous distal myotomes. Energy requirements were also lower when multisite DeRidder Burst was used.

Heterogeneous Cortical Effects of Spinal Cord Stimulation

ObjectivesThe understanding of the cortical effects of spinal cord stimulation (SCS) remains limited. Multiple studies have investigated the effects of SCS in resting-state electroencephalography. However, owing to the large variation in reported outcomes, we aimed to describe the differential cortical responses between two types of SCS and between responders and nonresponders using magnetoencephalography (MEG). Materials and MethodsWe conducted 5-minute resting-state MEG recordings in 25 patients with chronic pain with active SCS in three sessions, each after a one-week exposure to tonic, burst, or sham SCS. We extracted six spectral features from the measured neurophysiological signals: the alpha peak frequency; alpha power ratio (power 7–9 Hz/power 9–11 Hz); and average power in the theta (4–7.5 Hz), alpha (8–12.5 Hz), beta (13–30 Hz), and low-gamma (30.5–60 Hz) frequency bands. We compared these features (using nonparametric permutation t-tests) for MEG sensor and cortical map effects across stimulation paradigms, between participants who reported low (< 5, responders) vs high (≥ 5, nonresponders) pain scores, and in three representative participants. ResultsWe found statistically significant (p < 0.05, false discovery rate corrected) increased MEG sensor signal power below 3 Hz in response to burst SCS compared with tonic and sham SCS. We did not find statistically significant differences (all p > 0.05) between the power spectra of responders and nonresponders. Our data did not show statistically significant differences in the spectral features of interest among the three stimulation paradigms or between responders and nonresponders. These results were confirmed by the MEG cortical maps. However, we did identify certain trends in the MEG source maps for all comparisons and several features, with substantial variation across participants. ConclusionsThe considerable variation in cortical responses to the various SCS treatment options necessitates studies with sample sizes larger than commonly reported in the field and more personalized treatment plans. Studies with a finer stratification between responders and nonresponders are required to advance the knowledge on SCS treatment effects.

A Prospective, Randomized Single-Blind Crossover Study Comparing High-Frequency 10,000 Hz and Burst Spinal Cord Stimulation

ObjectivesAlthough both high-frequency and burst spinal cord stimulation (SCS) have shown improved efficacy and patient satisfaction compared with conventional tonic stimulation, there are limited data directly comparing the two. This study aimed to compare both high-frequency 10,000 Hz and burst SCS in the same patients in terms of pain relief and satisfaction in those with axial back pain with or without leg pain. Materials and MethodsThis prospective, single-blind, randomized controlled trial was conducted at an outpatient pain clinic within an academic medical center. Participants were randomly allocated to one of two groups in which they trialed either burst or high-frequency 10,000 Hz SCS over five days, followed by a 24- to 48-hour washout period with no stimulation, and the alternative therapy over the remaining four days. Visual analog scale (VAS) scores were collected immediately before and after both therapy trials. Secondary end points included percentage change in VAS score and patient preference. ResultsOf 25 participants, those receiving burst followed by high-frequency SCS (n = 11) had a mean VAS difference of 4.73 after the first trial period and 2.86 after the second. Of those receiving high-frequency followed by burst SCS (n = 14), mean VAS difference after the first trial period was 4.00 and 1.93 after the second trial period. Four participants were withdrawn owing to lead migration. Both therapies showed statistically significant differences in pre- minus post-VAS scores and percent relief. There were no significant differences in carryover or treatment effects between the two groups. There was a statistically significant association between trial sequence and stimulator type implanted because the first stimulator trialed was more likely to be chosen. ConclusionsThere were no observed differences in VAS pain score decrease when comparing burst and high-frequency 10,000 Hz SCS programming therapies. Patient preference followed an order effect, favoring the first programming therapy in the trial sequence.

Pulse Intensity Effects of Burst and Tonic Spinal Cord Stimulation on Neural Responses to Brushing in Patients With Neuropathic Pain

ObjectivesTonic spinal cord stimulation (SCS) is accompanied by paresthesia in affected body regions. Comparatively, the absence of paresthesia with burst SCS suggests different involvement of the dorsal column system conveying afferent impulses from low-threshold mechanoreceptors. This study evaluated cortical activation changes during gentle brushing of a pain-free leg during four SCS pulse intensities to assess the effect of intensity on recruitment of dorsal column system fibers during burst and tonic SCS. Materials and MethodsTwenty patients using SCS (11 burst, nine tonic) for neuropathic leg pain participated. Brushing was administered to a pain-free area of the leg during four SCS intensities: therapeutic (100%), medium (66%), low (33%), and no stimulation. Whole-brain electroencephalography was continuously recorded. Changes in spectral power during brushing were evaluated using the event-related desynchronization (ERD) method in theta (4–7 Hz), alpha (8–13 Hz), and beta (16–24 Hz) frequency bands. ResultsBrushing was accompanied by a suppression of cortical oscillations in the range 4–24 Hz. Stronger intensities of burst and tonic SCS led to less suppression of 4–7 Hz and 8–13 Hz bands in parietal electrodes, and in central electrodes in the 16–24 Hz band, with the strongest, statistically significant suppression at medium intensity. Tonic SCS showed a stronger reduction in 4–7 Hz oscillations over right sensorimotor electrodes, and over right frontal and left sensorimotor electrodes in the 8–13 Hz band, compared to burst SCS. ConclusionsResults suggest that burst and tonic SCS are mediated by both different and shared mechanisms. Attenuated brushing-related ERD with tonic SCS suggests a gating of cortical activation by afferent impulses in the dorsal column, whereas burst may engage different pathways. Diminished brushing-related ERD at medium and therapeutic intensities of burst and tonic SCS points towards a nonlinear effect of SCS on somatosensory processing.

Burst Transspinal Magnetic Stimulation Alleviates Nociceptive Pain in Parkinson Disease—A Pilot Phase II Double-Blind, Randomized Study

Background and AimsNociception is the most prevalent pain mechanism in Parkinson disease (PD). It negatively affects quality of life, and there is currently no evidence-based treatment for its control. Burst spinal cord stimulation has been used to control neuropathic pain and recently has been shown to relieve pain of nociceptive origin. In this study, we hypothesize that burst transspinal magnetic stimulation (bTsMS) reduces nociceptive pain in PD. Materials and MethodsTwenty-six patients were included in a double-blind, sham-controlled, randomized parallel trial design, and the analgesic effect of lower-cervical bTsMS was assessed in patients with nociceptive pain in PD. Five daily induction sessions were followed by maintenance sessions delivered twice a week for seven weeks. The primary outcome was the number of responders (≥ 50% reduction of average pain intensity assessed on a numerical rating scale ranging from 0–10) during the eight weeks of treatment. Mood, quality of life, global impression of change, and adverse events were assessed throughout the study. ResultsTwenty-six patients (46.2% women) were included in the study. The number of responders during treatment was significantly higher after active than after sham bTsMS (p = 0.044), mainly owing to the effect of the first week of treatment, when eight patients (61.5%) responded to active and two (15.4%) responded to sham bTsMS (p = 0.006); the number needed to treat was 2.2 at week 1. Depression symptom scores were lower after active (4.0 ± 3.1) than after sham bTsMS (8.7 ± 5.3) (p = 0.011). Patients’ global impressions of change were improved after active bTsMS (70.0%) compared with sham bTsMS (18.2%; p = 0.030). Minor adverse events were reported in both arms throughout treatment sessions. One major side effect unrelated to treatment occurred in the active arm (death due to pulmonary embolism). Blinding was effective. ConclusionBTsMS provided significant pain relief and improved the global impression of change in PD in this phase-II trial. Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT04546529.

Using evoked compound action potentials to quantify differential neural activation with burst and conventional, 40 Hz spinal cord stimulation in ovines.

We implanted 7 sheep with a dorsal stimulation lead at T9/T10, a dorsal ECAP sensing lead at T6/T7, and a lead also at T9/T10 but adjacent to the anterolateral system (ALS). Both burst and conventional SCS with stimulation amplitudes up to the visual motor threshold (vMT) were delivered to 3 different dorsal spinal locations, and ECAP thresholds (ECAPTs) were calculated for all combinations. Then, changes in ALS activation were assessed with both types of SCS. Evoked compound action potential thresholds and vMTs were significantly higher (P < 0.05) with conventional vs burst SCS, with no statistical difference (P > 0.05) among stimulation sites. However, the vMT-ECAPT window (a proxy for the useable therapeutic dosing range) was significantly wider (P < 0.05) with conventional vs burst SCS. No significant difference (P > 0.05) in ALS activation was noted between conventional and burst SCS. When dosed equivalently, no differentially unique change in ALS activation results with burst SCS vs conventional SCS; in addition, sub-ECAPT burst SCS results in no discernable excitability changes in the neural pathways feeding pain relevant supraspinal sites.

Rescue therapy with novel waveform spinal cord stimulation for patients with failed back surgery syndrome refractory to conventional stimulation: a systematic review and meta-analysis.

Conventional spinal cord stimulators (SCSs) have demonstrated efficacy in individuals with failed back surgery syndrome (FBSS). However, a subgroup of patients may become refractory to the effects of conventional waveforms over time. The objective of this study was to systematically review and evaluate the current literature on the use of novel waveform spinal cord stimulation for the management of FBSS refractory to conventional SCSs. A comprehensive electronic search of the literature published in electronic databases, including Ovid MEDLINE and Epub Ahead of Print, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus, was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The outcomes of interest were reduction in back pain and/or leg pain after conversion from conventional to novel SCSs. Risk of bias was assessed with the Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tool. The strength of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) criteria. A total of 6 studies with 137 patients with FBSS were identified. Studies were published between 2013 and 2021. The mean ± SD age of the pooled patient sample was 55 ± 10.5 years. All patients who underwent treatment with conventional SCSs were identified. Two studies evaluated the efficacy of high-density spinal cord stimulation, 3 studies evaluated burst spinal cord stimulation, and 1 study assessed multimodal waveforms. The mean difference in back pain scores after conversion from a standard SCS to a novel waveform SCS was 2.55 (95% CI 1.59-4.08), demonstrating a significant reduction in back pain after conversion to novel stimulation. The authors also performed a subgroup analysis to compare burst stimulation to tonic waveforms. In this analysis, the authors found no significant difference in the average reductions in back pain between the 2 groups (p = 0.534).The authors found an I2 statistic equivalent to 98.47% in the meta-regression model used to assess the effect of follow-up duration on study outcome; this value implied that the variability in the data can be attributed to the remaining between-study heterogeneity. The overall certainty was moderate, with a high risk of bias across studies. Rescue therapy with novel waveform spinal cord stimulation is a potential option for pain reduction in patients who become refractory to conventional SCSs. Conversion to novel waveform SCSs may potentially mitigate expenses and complications.

PO126 / #702 CLINICAL OUTCOMES USING A NEW FAST-ACTING SUB-PERCEPTION THERAPY FOR CHRONIC PAIN: A MULTICENTER EUROPEAN OBSERVATIONAL REAL-WORLD STUDY: E-POSTER VIEWING

Traditional Spinal Cord Stimulation (SCS) modalities that achieve sub-perception analgesia (e.g., ∼1-10 kHz, burst SCS) require patients to often wait hours or even days until pain relief is fully realized. A recent study however has demonstrated that quicker analgesic onset is possible using a new sub-threshold-based SCS modality called Fast-Acting Sub-Perception Therapy (FAST).1 While achieving rapid onset of pain relief offers a substantial advantage for patients and providers alike, the magnitude and quality of pain relief in patients using FAST in the real-world clinical setting is also an important consideration.

PO122 / #811 BURST SPINAL CORD STIMULATION AS A TREATMENT FOR DISCOGENIC LOW BACK PAIN: E-POSTER VIEWING

In patients with discogenic low back pain (DLBP), the intervertebral disc degenerates, and induces chronic pain 1,2. There is currently no there is currently no reliable, single long-term therapy available 3. For such patients, neuromodulation might be an option. The Burst stimulation paradigm has proven to be a viable option for patients with a wide variety of chronic pain syndromes. Data regarding the long-term effects of Burst spinal cord stimulation (SCS) for treatment of CD-LBP are currently lacking.

O084 / #701 NEUROSTIMULATION IS AN EFFECTIVE TREATMENT OPTION FOR CHRONIC BACK PAIN REGARDLESS OF PRIOR SPINAL SURGERY: TRACK 3: NEUROSTIMULATION FOR BACK AND LEG PAIN

Low back pain (LBP) has been one of the leading causes of disability worldwide for the past 30 years. Spinal cord stimulation (SCS) is a minimally invasive and reversible therapy, demonstrating increasing efficacy for the treatment of chronic pain when used earlier in the treatment algorithm. Despite this, SCS is frequently considered a last-line therapy option, often following surgical intervention. Here, we assess the outcomes of passive recharge burst SCS in surgically naïve subjects and those with persisting pain post-surgery.