Spinal Cord Stimulation System Research Articles

Biophysics of frequency-dependent variation in paresthesia and pain relief during spinal cord stimulation.

The neurophysiological effects of spinal cord stimulation (SCS) for chronic pain are poorly understood, resulting in inefficient failure-prone programming protocols and inadequate pain relief. Nonetheless, novel stimulation patterns are regularly introduced and adopted clinically. Traditionally, paresthetic sensation is considered necessary for pain relief, although novel paradigms provide analgesia without paresthesia. However, like pain relief, the neurophysiological underpinnings of SCS-induced paresthesia are unknown. Here, we paired biophysical modeling with clinical paresthesia thresholds (of both sexes) to investigate how stimulation frequency affects the neural response to SCS relevant to paresthesia and analgesia. Specifically, we modeled the dorsal column (DC) axonal response, dorsal column nucleus (DCN) synaptic transmission, conduction failure within DC fiber collaterals, and dorsal horn network output. Importantly, we found that high-frequency stimulation reduces DC fiber activation thresholds, which in turn accurately predicts clinical paresthesia perception thresholds. Furthermore, we show that high-frequency SCS produces asynchronous DC fiber spiking and ultimately asynchronous DCN output, offering a plausible biophysical basis for why high-frequency SCS is less comfortable and produces qualitatively different sensation than low-frequency stimulation. Finally, we demonstrate that model dorsal horn network output is sensitive to SCS-inherent variations in spike timing, which could contribute to heterogeneous pain relief across patients. Importantly, we show that model DC fiber collaterals cannot reliably follow high-frequency stimulation, strongly affecting network output and typically producing anti-nociceptive effects at high frequencies. Altogether, these findings clarify how SCS affects the nervous system and provide insight into the biophysics of paresthesia generation and pain relief.Significance Statement The effects of spinal cord stimulation (SCS) on the nervous system are poorly understood, resulting in inadequate clinical success rates. Here, we use a biophysical modeling approach to investigate the neural response to SCS. We demonstrate that low- and high-frequency stimulation produce contrasting responses in the dorsal columns, brainstem, and dorsal horn. Importantly, our modeling approach was able to accurately predict clinical paresthesia thresholds as a function of frequency, as well as provide plausible biophysical explanations for frequency-dependent effects on paresthesia quality and pain relief. Overall, our results greatly enhance our understanding of the neural response to SCS, thereby offering context for interpreting clinical observations and crucial insight for development of future SCS systems.

351 Comparing SCS and Conventional Medical Management in Patients With No Prior Back Surgery (SOLIS RCT)

INTRODUCTION: Spinal Cord Stimulation (SCS) as a treatment for chronic pain has been historically designated for patients who have had at least one prior spinal surgery. Modern SCS devices though now offer more novel technological capabilities and neurostimulative approaches than older-generational SCS systems. METHODS: This is a prospective, multicenter, randomized controlled trial (RCT) that compares therapeutic effectiveness of SCS versus CMM only, in patients with chronic low back and/or leg pain with no prior spinal surgery (SOLIS, Clinicaltrials.gov: NCT04676022). Enrolled NSBP patients are randomized to SCS combined with CMM (SCS + CMM arm) or a CMM-only arm. Those receving SCS are implanted with a multimodal system capable of engaging multiple mechanisms of action (Wavewriter Systems, Boston Scientific). Key inclusion criteria include diagnosis of chronic low back pain, with or without leg pain, for =6 months, and documented care of chronic pain for =90 days. The primary endpoint is responder rate (=50% reduction in pain) with no increase in baseline opioid medications to treat pain at 3-months following treatment activation. RESULTS: The primary endpoint (p < 0.0001) was met based on a prespecified cohort of 60 treatment-activated subjects. This analysis demonstrated that multimodal SCS combined with CMM was superior to CMM alone (p < 0.0001) in treating NSBP patients at 3-months follow-up (SCS: 88% versus CMM: 8%). Additionally, a 27-point reduction in Oswestry Disability Index score (improvement in disability) was noted in the SCS group versus a 6-point reduction in the CMM group. CONCLUSIONS: The data obtained in this RCT demonstrates that utilization of multimodal SCS provides for superior outcomes when compared to use of CMM alone for treatment of NSBP.

Neurophysiological outcomes that sustained clinically significant improvements over 3 years of physiologic ECAP-controlled closed-loop spinal cord stimulation for the treatment of chronic pain

IntroductionA novel, spinal cord stimulation (SCS) system with a physiologic closed-loop (CL) feedback mechanism controlled by evoked compound action potentials (ECAPs) enables the optimization of physiologic neural dose and the...

Improved Outcomes and Therapy Longevity after Salvage Using a Novel Spinal Cord Stimulation System for Chronic Pain: Multicenter, Observational, European Case Series.

Spinal cord stimulation (SCS) is proven to effectively relieve chronic neuropathic pain. However, some implanted patients may face loss of efficacy (LoE) over time, and conversion to more recent devices may rescue SCS therapy. Recent SCS systems offer novel stimulation capabilities, such as temporal modulation and spatial neural targeting, and can be used to replace previous neurostimulators without changing existing leads. Our multicenter, observational, consecutive case series investigated real-world clinical outcomes in previously implanted SCS patients who were converted to a new implantable pulse generator. Data from 58 patients in seven European centers were analyzed (total follow-up 7.0 years, including 1.4 years after conversion). In the Rescue (LoE) subgroup (n = 51), the responder rate was 58.5% at the last follow-up, and overall pain scores (numerical rating scale) had decreased from 7.3 ± 1.7 with the previous SCS system to 3.5 ± 2.5 (p < 0.0001). Patients who converted for improved battery longevity (n = 7) had their pain scores sustained below 3/10 with their new neurostimulator. Waveform preferences were diverse and patient dependent (34.4% standard rate; 44.8% sub-perception modalities; 20.7% combination therapy). Our results suggest that patients who experience LoE over time may benefit from upgrading to a more versatile SCS system.

Evoked compound action potential (ECAP)-controlled closed-loop spinal cord stimulation in an experimental model of neuropathic pain in rats

BackgroundPreclinical models of spinal cord stimulation (SCS) are lacking objective measurements to inform translationally applicable SCS parameters. The evoked compound action potential (ECAP) represents a measure of dorsal column fiber activation. This measure approximates the onset of SCS-induced sensations in humans and provides effective analgesia when used with ECAP-controlled closed-loop (CL)-SCS systems. Therefore, ECAPs may provide an objective surrogate for SCS dose in preclinical models that may support better understanding of SCS mechanisms and further translations to the clinics. This study assessed, for the first time, the feasibility of recording ECAPs and applying ECAP-controlled CL-SCS in freely behaving rats subjected to an experimental model of neuropathic pain.MethodsAdult male Sprague–Dawley rats (200–300 g) were subjected to spared nerve injury (SNI). A custom-made six-contact lead was implanted epidurally covering T11-L3, as confirmed by computed tomography or X-ray. A specially designed multi-channel system was used to record ECAPs and to apply ECAP-controlled CL-SCS for 30 min at 50 Hz 200 µs. The responses of dorsal column fibers to SCS were characterized and sensitivity towards mechanical and cold stimuli were assessed to determine analgesic effects from ECAP-controlled CL-SCS. Comparisons between SNI rats and their controls as well as between stimulation parameters were made using omnibus analysis of variance (ANOVA) tests and t-tests.ResultsThe recorded ECAPs showed the characteristic triphasic morphology and the ECAP amplitude (mV) increased as higher currents (mA) were applied in both SNI animals and controls (SNI SCS-ON and sham SCS-ON). Importantly, the use of ECAP-based SCS dose, implemented in ECAP-controlled CL-SCS, significantly reduced mechanical and cold hypersensitivity in SNI SCS-ON animals through the constant and controlled activation of dorsal column fibers. An analysis of conduction velocities of the evoked signals confirmed the involvement of large, myelinated fibers.ConclusionsThe use of ECAP-based SCS dose implemented in ECAP-controlled CL-SCS produced analgesia in animals subjected to an experimental model of neuropathic pain. This approach may offer a better method for translating SCS parameters between species that will improve understanding of the mechanisms of SCS action to further advance future clinical applications.

Spinal cord stimulation for chronic pain treatment following sacral chordoma resection: illustrative case.

Cancer-related or postoperative pain can occur following sacral chordoma resection. Despite a lack of current recommendations for cancer pain treatment, spinal cord stimulation (SCS) has demonstrated effectiveness in addressing cancer-related pain. A 76-year-old female with a sacral chordoma underwent anterior osteotomies and partial en bloc sacrectomy. She subsequently presented with chronic pain affecting both buttocks and posterior thighs and legs, significantly impeding her daily activities. She underwent a staged epidural SCS paddle trial and permanent system placement using intraoperative neuromonitoring. The utilization of percutaneous leads was not viable because of her history of spinal fluid leakage, multiple lumbosacral surgeries, and previous complex plastic surgery closure. The patient reported a 62.5% improvement in her lower-extremity pain per the modified Quadruple Visual Analog Scale and a 50% improvement in the modified Pain and Sleep Questionnaire 3-item index during the SCS trial. Following permanent SCS system placement and removal of her externalized lead extenders, she had an uncomplicated postoperative course and reported notable improvements in her pain symptoms. This case provides a compelling illustration of the successful treatment of chronic pain using SCS following radical sacral chordoma resection. Surgeons may consider this treatment approach in patients presenting with refractory pain following spinal tumor resection.

Conversion of a medical implant into a versatile computer-brain interface

BackgroundInformation transmission into the human nervous system is the basis for a variety of prosthetic applications. Spinal cord stimulation (SCS) systems are widely available, have a well documented safety record, can be implanted minimally invasively, and are known to stimulate afferent pathways. Nonetheless, SCS devices are not yet used for computer-brain-interfacing applications. ObjectiveHere we aimed to establish computer-to-brain communication via medical SCS implants in a group of 20 individuals who had been operated for the treatment of chronic neuropathic pain. MethodsIn the initial phase, we conducted interface calibration with the aim of determining personalized stimulation settings that yielded distinct and reproducible sensations. These settings were subsequently utilized to generate inputs for a range of behavioral tasks. We evaluated the required calibration time, task training duration, and the subsequent performance in each task. ResultsWe could establish a stable spinal computer-brain interface in 18 of the 20 participants. Each of the 18 then performed one or more of the following tasks: A rhythm-discrimination task (n = 13), a Morse-decoding task (n = 3), and/or two different balance/body-posture tasks (n = 18; n = 5). The median calibration time was 79 min. The median training time for learning to use the interface in a subsequent task was 1:40 min. In each task, every participant demonstrated successful performance, surpassing chance levels. ConclusionThe results constitute the first proof-of-concept of a general purpose computer-brain interface paradigm that could be deployed on present-day medical SCS platforms.

EE416 The Cost-Effectiveness of WaveWriter Alpha Spinal Cord Stimulation System in a Swedish Setting

EE416 The Cost-Effectiveness of WaveWriter Alpha Spinal Cord Stimulation System in a Swedish Setting

A retrospective review of elevated lead impedances in impedance-dependent magnetic resonance-conditional spinal cord stimulation devices.

Advances in Spinal cord stimulation (SCS) device technology in recent years have led to the development of SCS systems that are magnetic resonance imaging (MRI)-conditional, most of which are dependent on normal lead impedances. The objective of this study was to retrospectively analyze the rate of elevated lead impedance in these devices to determine the rate of failure of MR-conditional modes. This was a single-center, retrospective, chart-based review conducted during a five-year period. Patients were included if they had been implanted with an impedance-dependent MR-conditional SCS and had a documented impedance check at least 6 months after implantation. A Kaplan-Meier survival analysis was performed to map the survival of MR-conditionality over time. There were 363 cases included between 2015 and 2020, which corresponded to a total of 602 SCS leads. Nevro was the most common manufacturer (67.8%), followed by Boston Scientific (22.3%) and Abbott (9.9%). The average overall follow-up time was 2.25 years. Overall, 67 (18.5%) of patients had lead impedances over 10,000 Ω at follow-up with a total of 186 electrode contacts (3.9%). Leads most commonly had either one (40%), two (22%) or three (12%) electrode contacts out of range. Risk of failure of lead impedances increased by 35.4% with each successive year to a peak of 43% of all leads by year 5. Mean overall survival time of normal lead impedances was 4.77 years (CI 4.40-5.13). There was no statistically significant difference in mean overall survival time between Abbott (M = 4.0 years, SD = 1.25), Boston Scientific (M = 4.64 years, SD = 1.75) and Nevro (M = 4.80 years, SD = 3.28), χ2 (2, N = 358) = 1.511, p = 0.47; however, Abbott leads had a greater total number of failed impedance contacts (50/568, 8.8%), in comparison to Nevro (124/3064, 4.0%), χ2 (1, N = 3630) = 23.76, p < 0.00001, at a similar follow-up time. This retrospective study identified elevated impedances in 18.5% of MR-conditional SCS devices at an average of 2.25 years follow-up resulting in loss of MR-conditionality and a mean overall lead survival time of 4.77 years for normal lead impedance.

Device profile of the Evoke physiologic closed-loop spinal cord stimulation system for the treatment of chronic intractable pain: overview of its safety and efficacy

ABSTRACT Introduction The Evoke® spinal cord stimulation (SCS) device enables the closed-loop feedback of dynamically measured evoked compound action potentials (ECAPs) to adjust stimulation amplitude for every stimulation pulse to maintain the stimulation output level near a targeted ECAP amplitude. No other commercially available SCS device presently uses physiologic feedback from the spinal cord to adjust stimulation. Clinicians should be familiar with the differences in devices and with the latest technologies to provide optimized patient care. Areas covered In this device profile, the Evoke system is described and the system capabilities are differentiated from other available SCS devices. A systematic review was conducted based on best practice guidance to identify all available evidence on the safety and efficacy of the Evoke SCS system. Expert opinion The Evoke SCS system offers unique capabilities as a means to optimize therapy delivery tailored to each individual patient. Data through 24-months follow-up show statistically significant, clinically meaningful, ample, consistent, and strong evidence of the safety and efficacy of the Evoke system for the treatment of chronic intractable pain.

Objective wearable measures correlate with self-reported chronic pain levels in people with spinal cord stimulation systems

Spinal Cord Stimulation (SCS) is a well-established therapy for treating chronic pain. However, perceived treatment response to SCS therapy may vary among people with chronic pain due to diverse needs and backgrounds. Patient Reported Outcomes (PROs) from standard survey questions do not provide the full picture of what has happened to a patient since their last visit, and digital PROs require patients to visit an app or otherwise regularly engage with software. This study aims to assess the feasibility of using digital biomarkers collected from wearables during SCS treatment to predict pain and PRO outcomes. Twenty participants with chronic pain were recruited and implanted with SCS. During the six months of the study, activity and physiological metrics were collected and data from 15 participants was used to develop a machine learning pipeline to objectively predict pain levels and categories of PRO measures. The model reached an accuracy of 0.768 ± 0.012 in predicting the pain intensity of mild, moderate, and severe. Feature importance analysis showed that digital biomarkers from the smartwatch such as heart rate, heart rate variability, step count, and stand time can contribute to modeling different aspects of pain. The results of the study suggest that wearable biomarkers can be used to predict therapy outcomes in people with chronic pain, enabling continuous, real-time monitoring of patients during the use of implanted therapies.

Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial

AimsTo evaluate the long-term efficacy of high-frequency (10 kHz) spinal cord stimulation (SCS) for treating refractory painful diabetic neuropathy (PDN). MethodsThe SENZA-PDN study was a prospective, multicenter, randomized controlled trial that compared conventional medical management (CMM) alone with 10 kHz SCS plus CMM (10 kHz SCS+CMM) in 216 patients with refractory PDN. After 6 months, participants with insufficient pain relief could cross over to the other treatment. In total, 142 patients with a 10 kHz SCS system were followed for 24 months, including 84 initial 10 kHz SCS+CMM recipients and 58 crossovers from CMM alone. Assessments included pain intensity, health-related quality of life (HRQoL), sleep, and neurological function. Investigators assessed neurological function via sensory, reflex, and motor tests. They identified a clinically meaningful improvement relative to the baseline assessment if there was a significant persistent improvement in neurological function that impacted the participant’s well-being and was attributable to a neurological finding. ResultsAt 24 months, 10 kHz SCS reduced pain by a mean of 79.9% compared to baseline, with 90.1% of participants experiencing ≥50% pain relief. Participants had significantly improved HRQoL and sleep, and 65.7% demonstrated clinically meaningful neurological improvement. Five (3.2%) SCS systems were explanted due to infection. ConclusionsOver 24 months, 10 kHz SCS provided durable pain relief and significant improvements in HRQoL and sleep. Furthermore, the majority of participants demonstrated neurological improvement. These long-term data support 10 kHz SCS as a safe and highly effective therapy for PDN.Trial Registration: ClincalTrials.gov Identifier, NCT03228420.

First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain.

A novel closed-loop spinal cord stimulation (SCS) system has recently been approved for use which records evoked compound action potentials (ECAPs) from the spinal cord and utilizes these recordings to automatically adjust the stimulation strength in real time. It automatically compensates for fluctuations in distance between the epidural leads and the spinal cord by maintaining the neural response (ECAP) at a determined target level. This data collection was principally designed to evaluate the performance of this first closed-loop SCS system in a 'real-world' setting under normal conditions of use in a single European center. In this prospective, single-center observational data collection, 22 patients were recruited at the outpatient pain clinic of the St. Antonius Hospital. All candidates were suffering from chronic pain in the trunk and/or limbs due to PSPS type 2 (persistent spinal pain syndrome). As standard of care, follow-up visits were completed at 3months, 6months, and 12months post-device activation. Patient-reported outcome data (pain intensity, patient satisfaction) and electrophysiological and device data (ECAP amplitude, conduction velocity, current output, pulse width, frequency, usage), and patient interaction with their controller were collected at baseline and during standard of care follow-up visits. Significant decreases in pain intensity for overall back or leg pain scores (verbal numerical rating score=VNRS) were observed between baseline [mean±SEM (standard error of the mean); n=22; 8.4±0.2)], 3months (n=12; 1.9±0.5), 6months (n=16; 2.6±0.5), and 12months (n=20; 2.0±0.5), with 85.0% of the patients being satisfied at 12months. Additionally, no significant differences in average pain relief at 3months and 12months between the real-world data (77.2%; 76.8%) and the AVALON (71.2%; 73.6%) and EVOKE (78.1%; 76.7%) studies were observed. These initial 'real-world' data on ECAP-controlled, closed-loop SCS in a real-world clinical setting appear to be promising, as they provide novel insights of the beneficial effect of ECAP-controlled, closed-loop SCS in a real-world setting. The presented results demonstrate a noteworthy maintenance of pain relief over 12months and corroborate the outcomes observed in the AVALON prospective, multicenter, single-arm study and the EVOKE double-blind, multicenter, randomized controlled trial. The data collection is registered on the International Clinical Trials Registry Platform (Trial NL7889).

A Novel, Paresthesia-Free Spinal Cord Stimulation Waveform for Chronic Neuropathic Low Back Pain: Six-Month Results of a Prospective, Single-Arm, Dose-Response Study

ObjectivesThe aim of this prospective, single-blinded, dose-response study was to evaluate the safety and efficacy of a novel, paresthesia-free (subperception) spinal cord stimulation (SCS) waveform designed to target dorsal horn dendrites for the treatment of chronic neuropathic low back pain (LBP). Materials and MethodsTwenty-seven participants with chronic neuropathic LBP were implanted with a commercial SCS system after a successful trial of SCS therapy. Devices were programmed to deliver the investigative waveform (100 Hz, 1000 μs, T9/T10 bipole) at descending stimulation perception threshold amplitudes (80%, 60%, 40%). Programs were evaluated at six, ten, and 14 weeks, after which participants selected their preferred program, with more follow-up at 26 weeks (primary outcomes). Participants were blinded to the nature of the programming. Pain score (visual analog scale [VAS]), Brief Pain Inventory (BPI), quality of life (EQ-5D-5L), and health status (36-Item Short Form [SF-36]) were measured at baseline and follow-ups. Responder rate, treatment satisfaction, clinician global impression of change, and adverse events (AEs) also were evaluated. ResultsMean (± SD) baseline VAS was 72.5 ± 11.2 mm. At 26 weeks (n = 26), mean change from baseline in VAS was −51.7 mm (95% CI, −60.7 to −42.7; p < 0.001), with 76.9% of participants reporting ≥50% VAS reduction, and 46.2% reporting ≥80% VAS reduction. BPI, EQ-5D-5L, and SF-36 scores were all statistically significantly improved at 26 weeks (p < 0.001), and 100% of participants were satisfied with their treatment. There were no unanticipated AEs related to the study intervention, device, or procedures. ConclusionsThis novel, paresthesia-free stimulation waveform may be a safe and effective option for patients with chronic neuropathic LBP eligible for SCS therapy and is deliverable by all current commercial SCS systems. Clinical Trial RegistrationThis study is registered on anzctr.org.au with identifier ACTRN12618000647235.

Should we Oppose or Combine Waveforms for Spinal Cord Stimulation in PSPS-T2 Patients? A Prospective Randomized Crossover Trial (MULTIWAVE Study)

Refractory persistent spinal pain syndrome after surgery (PSPS-T2) can be successfully addressed by spinal cord stimulation (SCS). While conventional stimulation generates paresthesia, recent systems enable the delivery of paresthesia-free stimulation. Studies have claimed non-inferiority/superiority of selected paresthesia-free stimulation compared with paresthesia-based stimulation, but the comparative efficacy between different waveforms still needs to be determined in a given patient. We designed a randomized controlled 3-month crossover trial to compare pain relief of paresthesia-based stimulation versus high frequency versus burst in 28 PSPS-T2 patients implanted with multiwave SCS systems. Our secondary objectives were to determine the efficacy of these 3 waveforms on pain surface, quality of life, functional capacity, psychological distress, and validated composite multidimensional clinical response index to provide holistic comparisons at 3-, 6-, 9-, and 15-month post-randomization. The preferred stimulation modality was documented during the follow-up periods. No difference between the waveforms was observed in this study (P = .08). SCS led to significant pain relief, quality of life improvement, improvement of multidimensional clinical response index, and of all other clinical outcomes at all follow-up visits. Forty-four percent of the patients chose to keep the paresthesia-based stimulation modality after the 15-month follow-up period. By giving the possibility to switch and/or to combine several waveforms, the overall rate of SCS responders further increased with 25%. In this study, high frequency or burst do not appear superior to paresthesia-based stimulation, wherefore paresthesia-based stimulation should still be considered as a valid option. However, combining paresthesia-based stimulation with paresthesia-free stimulation, through personalized multiwave therapy, might significantly improve SCS responses. PerspectiveThis article assesses clinical SCS efficacy on pain relief, by comparing paresthesia-based stimulation and paresthesia-free stimulation (including high frequency and burst) modalities in patient presenting with PSPS-T2. Switching and/or combining waveforms contribute to increasing the global SCS responders rate.

Differential target multiplexed spinal cord stimulation using a paddle-type lead placed at the appropriate site for neuropathic pain after spinal cord injury in patients with past spinal surgical histories: study protocol for an exploratory clinical trial

BackgroundNeuropathic pain after spinal cord injury (SCI), both traumatic and non-traumatic, is refractory to various treatments. Spinal cord stimulation (SCS) is one of the neuromodulation therapies for neuropathic pain, although SCS has insufficient efficacy for neuropathic pain after SCI. The reasons are presumed to be inappropriate locations of SCS leads and conventional tonic stimulation itself does not have a sufficient analgesic effect for the pain. In patients with past spinal surgical histories, the cylinder-type leads are likely to be placed on the caudal side of the SCI because of surgical adhesions. Differential target multiplexed (DTM) stimulation is one of the latest new stimulation patterns that is superior to conventional stimulation.MethodsA single-center, open-label, randomized, two-way crossover trial is planned to investigate the efficacy of SCS using DTM stimulation placing a paddle lead at the appropriate site for neuropathic pain after SCI in patients with spinal surgical histories. The paddle-type lead delivers energy more efficiently than a cylinder-type lead. This study consists of two steps: SCS trial (first step) and SCS system implantation (second step). The primary outcome is rates of achieving pain improvement with more than 33% reduction 3 months after SCS system implantation. The secondary outcomes are to be evaluated as follows: (1) effectiveness of DTM and tonic stimulations during the SCS trial; (2) changes of assessment items from 1 to 24 months; (3) relationships between the result of the SCS trial and the effects 3 months after SCS system implantation; (4) preoperative factors associated with a long-term effect, defined as continuing for more than 12 months; and (5) whether gait function improves from 1 to 24 months.DiscussionA paddle-type lead placed on the rostral side of SCI and using DTM stimulation may provide significant pain relief for patients with intractable neuropathic pain after SCI in patients with past spinal surgical histories.Trial registrationJapan Registry of Clinical Trials (jRCT) jRCT 1042220093. Registered on 21 November 2022, and last modified on 6 January 2023. jRCT is approved as a member of the Primary Registry Network of WHO ICTRP.

ID: 214658 First-in-Human Experience With an Implantable SCS System With Automated Daily Remote Monitoring and Remote Programming

The BENEFIT-03 Study (NCT04683718) is designed to evaluate the safety and effectiveness of an implantable spinal cord stimulation (SCS) system with multiphase stimulation and remote device management. While results of an SCS teleprogramming pilot study have been reported previously,1 to our knowledge, BENEFIT-03 is the world’s first long-term study of an SCS system with automated remote device monitoring and remote programming capabilities.

ID: 199376 Improved Pain Outcomes and Therapy Longevity After Salvage Using Novel SCS Systems: European Experience

Some patients implanted with a Spinal Cord Stimulation (SCS) device for treatment of chronic pain can experience loss or attenuation in therapeutic efficacy over time. To avoid or cope with this potential issue, customized delivery of neurostimulation may be an important tool in that various SCS-device waveforms and programming options can be applied more precisely in order to optimize treatment to the needs of the individual patient. However, technologies that offer patient-specific customization capabilities are not accessible to long-term implanted patients using older devices. Thus, in order to access these new technologies, patients can undergo a "conversion" to a different SCS system that does possess these capabilities. In this study, we assessed a cohort of previously-implanted patients who converted to a new SCS device capable of combination therapy (simultaneous or sequential delivery of multiple available waveforms), enhanced algorithmic-based stimulation field targeting, and waveform automation.

ID: 213534 Early Outcomes With the Medtronic Closed-Loop Spinal Cord Stimulation Study

Spinal cord stimulation (SCS) is a therapy for the treatment of chronic pain that relies on the application of mild electrical stimulation delivered to the dorsal column fibers of the spinal cord via lead(s) implanted in the epidural space. Most of the current SCS systems do not adjust the stimulation to reflect changes in distance between the SCS lead and the cord during activities of daily living. Hence, the net energy delivered varies dynamically resulting in inconsistent therapy delivery i.e., open-loop (OL) SCS.1 Closed-Loop SCS (CL SCS), where the therapy is titrated by the physiologic response of the spinal cord to stimulation – known as evoked compound action potential (ECAPs),2 can be used to address this limitation of OL SCS systems. The objective of this study is to evaluate patient experience and therapy durability with CL SCS. Primary study objective is to demonstrate the reduction in overstimulation sensation with the CL feature in subjects implanted with the CL SCS system. Secondary objectives include characterizing therapy efficacy in reducing overall, back or leg pain as measured by the proportion of subjects with ≥50% reduction in pain score, at the time of the 3-month visit. Consistency of dosing and long-term durability of therapy will also be characterized.

ID: 210553 Clinical Feasibility of ECAP-Controlled, Closed-Loop Spinal Cord Stimulation With Cervically Placed Leads

Recent advances in spinal cord stimulation (SCS) have focused on two highly novel areas; Differential Target MultiplexedTM SCS (DTM) [1], which has demonstrated superior pain relief, and the spinal Evoked Compound Action Potential (ECAP), a bioelectrical signal used as a measure of neural activation with closed-loop (CL) SCS systems to compensate for motion at the electrode-tissue interface [2]. Due to thinner cerebral spinal fluid (CSF) and the large mobility in the cervical space compared to the thoracic space [3], the use of ECAP-controlled SCS systems for upper limb pain may reduce uncomfortable stimulation delivered to patients and decrease the variation in stimulation delivered to the cord. In this study, ECAP-controlled closed-loop DTMTM SCS was explored to assess feasibility with cervically placed SCS leads in an in-clinic environment.