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Object: Spinal cord stimulation (SCS) is a well-known treatment option for intractable neuropathic pain after spinal surgery, but its pathophysiological mechanisms are poorly stated. The goal of this study is to analyse the feasibility of using brain MRI, functional MRI (fMRI) and Magnetic Resonance Spectroscopy (MRS) as tools to analyse these mechanisms in patients with externalised neurostimulators during trial period., Methods: The authors conducted in an in vitro and in vivo study analysing safety issues when performing brain MRI, fMRI and MRS investigations in human subjects with externalised SCS. Temperature measurements in vitro were performed simulating SCS during MRI sequences using head transmit-receive coils in 1.5 and 3 T MRI systems. 40 Patients with externalised SCS were included in the in vivo study. 20 patients underwent brain MRI, fMRI and another 20 patients underwent brain MRI and MRS., Results: A maximal temperature increase of 0.2°C was measured and neither electrode displacements nor hardware failures were observed. None of the patients undergoing the MRS sequences at the 1.5 or 3 T MRI scanners described any discomfort or unusual sensations., Conclusion: We can conclude that brain MRI, fMRI and MRS studies performed in patients with externalised SCS can be safely executed., (Copyright © 2011 Elsevier B.V. All rights reserved.)

Objective: Spinal cord stimulation is an effective treatment for chronic neuropathic pain after spinal surgery. In addition to the most common placement of electrodes at the thoracic level for low back and leg pain, electrodes can also be placed on a cervical level in patients with chronic neck and upper limb pain. Surgical insertion of plate electrodes via an orthodromal direction requires a partial laminectomy. Therefore, the authors describe a surgical technique using retrograde insertion of a plate electrode to avoid laminectomy., Methods: Six patients with uncontrolled neck and upper limb pain despite optimal analgesic medication were treated with a surgical electrode placed at the C1-C2 level via a retrograde placement technique without laminectomy., Results: All patients received stimulation paresthesias at the desired regions and reported significant pain reduction in the neck and arm regions., Conclusion: This retrograde placement of plate electrodes enables cervical lordosis to be overcome and results in adequate stimulation of the upper cervical region, which is mandatory to reduce neck and shoulder pain without laminectomy., (Crown Copyright © 2011. Published by Elsevier Inc. All rights reserved.)

Introduction: In the search for objective measures of therapeutic outcomes for patients with spinal cord stimulation (SCS) devices, various metrics of cardiac performance have been linked to pain as well as overall health. To track such measures at home, recent studies have incorporated wearables to monitor cardiac activity over months or years. The drawbacks to wearables, such as patient compliance, would be obviated by on-device sensing that incorporates the SCS lead. This study sought to evaluate the feasibility of using SCS leads to record cardiac electrograms. Methods: The quality of signals sensed by externalized, percutaneous leads in the thoracic spine of 10 subjects at the end of their SCS trial were characterized across various electrode configurations and postures by detecting R-peaks and calculating signal-to-noise ratio (SNR). In a subset of 5 subjects, cardiac metrics were then compared to those measured simultaneously with a wearable. Results: The average signal quality was acceptable for R-peak detection (i.e., SNR > 5) for all configurations and positions across all 10 subjects, with higher signal quality achieved when recording in resting positions. Notably, the spinal lead recordings enabled more reliable beat detection compared to the wearable (n = 29 recording pairs; p < 0.001). When excluding wearable recordings with over 35% missed beats, the inter-beat intervals across devices were highly correlated (n = 22 recording pairs; Pearson correlation: R = 0.99, p < 0.001). Further comparisons in these aligned wearable and corresponding spinal-lead recordings revealed significant differences in the frequency domain metrics (i.e., absolute and normalized high and low frequency HRV power, p < 0.05), but not in time domain HRV parameters. Discussion: The ability of an implanted SCS system to record electrocardiograms, as demonstrated here, could provide the basis of automated SCS therapy by tracking potential biomarkers of the patient's overall health state without the need for additional external devices. [ABSTRACT FROM AUTHOR]

Background: Spinal Cord Stimulation (SCS) may provide pain relief in patients with therapy-refractory Persistent Spinal Pain Syndrome Type II (PSPS-T2). Despite the evidence that SCS can reduce disability and reduce pain medication usage, only 25% of the patients is able to completely omit pain medication usage after 12 months of SCS. To tackle the high burden of patients who consume a lot of pain medication, tapering programs could be initiated before starting a trajectory with SCS. The current objective is to examine whether a pain medication tapering program before SCS alters disability in PSPS-T2 patients compared to no tapering program. Methods and design: A three-arm, parallel-group multicenter randomized controlled trial will be conducted including 195 patients who will be randomized (1:1:1) to either (a) a standardized pain medication tapering program, (b) a personalized pain medication tapering program, or (c) no tapering program before SCS implantation, all with a follow-up period until 12 months after implantation. The primary outcome is disability. The secondary outcomes are pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication usage, psychological constructs, sleep, symptoms of central sensitization, and healthcare expenditure. Discussion: Within the PIANISSIMO project we propose a way to reduce the risks of adverse events, medication-induced hyperalgesia, tolerance, and dependence by providing pain medication tapering before SCS. Due to the lack of a commonly accepted in-hospital tapering approach, two different tapering programs will be evaluated in this study. If pain medication tapering programs are deemed to be more effective than no tapering on disability, this would add to the evidence towards an improved patient-centered care model in this patient group and set a clear path to advocate for pain medication tapering before SCS as the new standard treatment guideline for these patients. Trial registration: ClinicalTrials.gov NCT05861609. Registered on May 17, 2023. [ABSTRACT FROM AUTHOR]

Introduction: Spinal cord stimulation is a common treatment option for neuropathic pain conditions. Despite its extensive use and multiple technological evolutions, long term efficacy of spinal cord stimulation is debated. Most studies on spinal cord stimulation include a rather limited number of patients and/or follow-ups over a limited period. Therefore, there is an urgent need for real-world, long-term data. Methods: In 2018, the Belgian government initiated a nationwide secure platform for the follow-up of all new and existing spinal cord stimulation therapies. This is a unique approach used worldwide. Four years after the start of centralized recording, the first global extraction of data was performed. Results: Herein, we present the findings, detailing the different steps in the centralized procedure, as well as the observed patient and treatment characteristics. Furthermore, we identified dropouts during the screening process, the reasons behind discontinuation, and the evolution of key indicators during the trial period. In addition, we obtained the first insights into the evolution of the clinical impact of permanent implants on the overall functioning and quality of life of patients in the long-term. Discussion: Although these findings are the results of the first data extraction, some interesting conclusions can be drawn. The long-term outcomes of neuromodulation are complex and subject to many variables. Future data extraction will allow us to identify these confounding factors and the early predictors of success. In addition, we will propose further optimization of the current process. [ABSTRACT FROM AUTHOR]

Spinal cord (SC) anatomy is often assimilated to a morphologically encapsulated neural entity, but its functional anatomy remains only partially understood. We hypothesized that it could be possible to re-explore SC neural networks by performing live electrostimulation mapping, based on "super-selective" spinal cord stimulation (SCS), originally designed as a therapeutical tool to address chronic refractory pain. As a starting point, we initiated a systematic SCS lead programming approach using live electrostimulation mapping on a chronic refractory perineal pain patient, previously implanted with multicolumn SCS at the level of the conus medullaris (T12-L1). It appeared possible to (re-)explore the classical anatomy of the conus medullaris using statistical correlations of paresthesia coverage mappings, resulting from 165 different electrical configurations tested. We highlighted that sacral dermatomes were not only located more medially but also deeper than lumbar dermatomes at the level of the conus medullaris, in contrast with classical anatomical descriptions of SC somatotopical organization. As we were finally able to find a morphofunctional description of "Philippe–Gombault's triangle" in 19th-century historical textbooks of neuroanatomy, remarkably matching these conclusions, the concept of "neuro-fiber mapping" was introduced. [ABSTRACT FROM AUTHOR]

Background: For patients with therapy-refractory persistent spinal pain syndrome type II (PSPS-T2), spinal cord stimulation (SCS) may serve as an effective minimally invasive treatment. Despite the evidence that SCS can improve return to work (RTW), only 9.5 to 14% of patients implanted with SCS are effectively capable of returning to work. Thus, it seems that current post-operative interventions are not effective for achieving RTW after SCS implantation in clinical practice. The current objective is to examine whether a personalised biopsychosocial rehabilitation programme specifically targeting RTW alters the work ability in PSPS-T2 patients after SCS implantation compared to usual care.Methods: A two-arm, parallel-group multicentre randomised controlled trial will be conducted including 112 patients who will be randomised (1:1) to either (a) a personalised biopsychosocial RTW rehabilitation programme of 14 weeks or (b) a usual care arm, both with a follow-up period until 12 months after the intervention. The primary outcome is work ability. The secondary outcomes are work status and participation, pain intensity, health-related quality of life, physical activity and functional disability, functional capacities, sleep quality, kinesiophobia, self-management, anxiety, depression and healthcare expenditure.Discussion: Within the OPERA project, we propose a multidisciplinary personalised biopsychosocial rehabilitation programme specifically targeting RTW for patients implanted with SCS, to tackle the high socio-economic burden of patients that are not re-entering the labour market. The awareness is growing that the burden of PSPS-T2 on our society is expected to increase over time due to the annual increase of spinal surgeries. However, innovative and methodologically rigorous trials exploring the potential to decrease the socio-economic burden when patients initiate a trajectory with SCS are essentially lacking.Trial Registration: ClinicalTrials.gov NCT05269212. Registered on 7 March 2022. [ABSTRACT FROM AUTHOR]

Spinal cord stimulation (SCS) is an effective and validated treatment to address chronic refractory neuropathic pain in persistent spinal pain syndrome-type 2 (PSPS-T2) patients. Surgical SCS lead placement is traditionally performed under general anesthesia due to its invasiveness. In parallel, recent works have suggested that awake anesthesia (AA), consisting of target controlled intra-venous anesthesia (TCIVA), could be an interesting tool to optimize lead anatomical placement using patient intra-operative feedback. We hypothesized that combining AA with minimal invasive surgery (MIS) could improve SCS outcomes. The goal of this study was to evaluate SCS lead performance (defined by the area of pain adequately covered by paraesthesia generated via SCS), using an intraoperative objective quantitative mapping tool, and secondarily, to assess pain relief, functional improvement and change in quality of life with a composite score. We analyzed data from a prospective multicenter study (ESTIMET) to compare the outcomes of 115 patients implanted with MIS under AA (MISAA group) or general anesthesia (MISGA group), or by laminectomy under general anesthesia (LGA group). All in all, awake surgery appears to show significantly better performance than general anesthesia in terms of patient pain coverage (65% vs. 34–62%), pain surface (50–76% vs. 50–61%) and pain intensity (65% vs. 35–40%), as well as improved secondary outcomes (quality of life, functional disability and depression). One step further, our results suggest that MISAA combined with intra-operative hypnosis could potentialize patient intraoperative cooperation and could be proposed as a personalized package offered to PSPS-T2 patients eligible for SCS implantation in highly dedicated neuromodulation centers. [ABSTRACT FROM AUTHOR]

Despite the well-known efficacy of spinal cord stimulation (SCS) in chronic pain management, patient selection in clinical practice remains challenging. The aim of this review is to provide an overview of the factors that can influence the process of patient selection for SCS treatment. A sequential decision-making model is presented within a tier system that operates in clinical practice. The first level incorporates the underlying disease as a primary indication for SCS, country-related reimbursement rules, and SCS screening–trial criteria in combination with underlying psychological factors as initial selection criteria in evaluating patient eligibility for SCS. The second tier is aligned with the individualized approach within precision pain medicine, whereby individual goals and expectations and the potential need for preoperative optimizations are emphasized. Additionally, this tier relies on results from prediction models to provide an estimate of the efficacy of SCS in the long term. In the third tier, selection bias, MRI compatibility, and ethical beliefs are included, together with recent technological innovations, superiority of specific stimulation paradigms, and new feedback systems that could indirectly influence the decision-making of the physician. Both patients and physicians should be aware of the different aspects that influence patient selection in relation to SCS for pain management to make an independent decision on whether or not to initiate a treatment trajectory with SCS. [ABSTRACT FROM AUTHOR]

Pain researchers demonstrated that pain intensity is not the most reliable measure of the success of chronic-pain treatment. Several research groups have proposed "core outcome domains", such as measurements of disability, to assess the effect of an intervention in pain patients. Up till now, studies investigating the relation between pain intensity and disability in patients treated with spinal cord stimulation (SCS) are lacking. Therefore, the current objective is to examine which pain-reporting strategy, routinely used in pain research, associates best with the degree of disability in these patients. Eighty-one failed back surgery syndrome patients (37 males and 44 females, mean age 54.6 years), treated with high-dose spinal cord stimulation (HD-SCS) are recruited. Pain intensity was scored on an 11-point numerical rating scale (NRS) for leg and back pain, while disability was assessed with the Oswestry disability index (ODI). The association between both variables was investigated with Spearman's correlation and Cramér's V. Significant correlations (p < 0.001) are found between the absolute and relative differences of the ODI and NRS. Significant associations were found between reported cut-offs in literature (≤3, ≤5, and 50% pain relief) and the degree of disability. Finally, a significant association (p < 0.001) was found between the minimal clinical important difference. In this study, we showed that the degree of disability was strongly associated with the pain intensity as measured using different methods. The standard method for reporting pain intensity reduction (50%) seems to associate the strongest with the degree of disability. However, a low degree of disability does not always reflect a low pain intensity. The degree of disability reveals a good association with the reporting methods of pain intensity from the literature. The Oswestry disability index could serve as a valid tool to measure the effect of spinal cord stimulation on pain. Disability measures offer a better insight in the clinical profile of chronic pain patients than a pain intensity score. [ABSTRACT FROM AUTHOR]

Introduction: The effectiveness of spinal cord stimulation (SCS) as pain‐relieving treatment for failed back surgery syndrome (FBSS) has already been demonstrated. However, potential structural and functional brain alterations resulting from subsensory SCS are less clear. The aim of this study was to test structural volumetric changes in a priori chosen regions of interest related to chronic pain after 1 month and 3 months of high‐frequency SCS in patients with FBSS. Methods: Eleven patients with FBSS who were scheduled for SCS device implantation were included in this study. All patients underwent a magnetic resonance imaging protocol before SCS device implantation 1 and 3 months after high‐frequency SCS. Pain intensity, pain catastrophizing, and sleep quality were also measured. Regions‐of‐interest voxel‐based morphometry was used to explore grey matter volumetric changes over time. Additionally, volumetric changes were correlated with changes in pain intensity, catastrophizing, and sleep quality. Results: Significant decreases were found in volume in the left and right hippocampus over time. More specifically, a significant difference was revealed between volumes before SCS implantation and after 3 months of SCS. Repeated‐measures correlations revealed a significant positive correlation between volumetric changes in the left hippocampus and changes in back pain score over time and between volumetric changes in the right hippocampus and changes in back pain score over time. Conclusion: In patients with FBSS, high‐frequency SCS influences structural brain regions over time. The volume of the hippocampus was decreased bilaterally after 3 months of high‐frequency SCS with a positive correlation with back pain intensity. [ABSTRACT FROM AUTHOR]

Introduction: Due to the difficulties encountered in the treatment process of patients with chronic pain, it is of utmost importance to involve patients themselves in their rehabilitation trajectory. Patient engagement can be obtained by motivating patients to select their own treatment goals. We hypothesize that applying goal setting, as a form of patient empowerment, in potential candidates for spinal cord stimulation (SCS) may further improve the outcome of SCS. As a first step in creating patient empowerment, patients' goals that they aim to achieve with SCS will be explored. Methods: Fifteen patients suffering from failed back/neck surgery syndrome and scheduled for SCS were interviewed in depth. All interviews were audio recorded and analyzed using in vivo coding. Afterwards, the International Classification of Functioning, Disability and Health framework was used to structure the responses of patients. Results: In the domain of bodily functions, all patients mentioned pain reduction, and 1 patient wanted to regain his previous sleep pattern. In the domain of activities, walking, sitting, driving a car, bending down, and picking up were the highest ranked goals. Regaining a social life was the highest ranked goal for participation. Eleven patients wanted to regain a feeling of happiness, and 5 patients wanted to focus on avoiding depression. Conclusion: The interviews revealed a broad spectrum of individual patients' goals, highlighting the need of individually targeted rehabilitation trajectories in the field of neuromodulation. Goal identification could entail the first step towards individualized medicine in the SCS trajectory. [ABSTRACT FROM AUTHOR]

Background: Building on the recent finding that chronic pain patients with impaired functioning of the descending nociceptive inhibitory system (DNIS) present lower resting heart rate variability (HRV), this study aims to investigate the impact of Spinal Cord Stimulation (SCS) on HRV in patients with Failed Back Surgery Syndrome (FBSS). More precisely, we hypothesize that SCS influences the DNIS, with increased parasympathetic tone as a consequence, as measurable by HRV analysis. Methods: Twenty-two patients diagnosed with FBSS and treated with SCS participated in this study. HRV was measured with a 2-lead ECG registration tool during on and off states of SCS. HRV analysis for time, frequency, time-frequency and nonlinear domain parameters was based on a 5-minute recording segment. Results: The mean heart rate and low frequency power were significantly lower when SCS was activated. HRV, absolute and normalized high frequency power significantly increased during SCS compared to without SCS. The ratio of low frequency/high frequency ratios, as parameter for global sympathetic-parasympathetic equilibrium, significantly decreased when SCS was activated. Conclusions: When SCS is switched off, patients with FBSS present relatively stronger sympathetic tone and weaker parasympathetic activity. Activation of the SCS, possibly via stimulation of the DNIS, restores this disbalance of autonomic activity. [ABSTRACT FROM AUTHOR]

Background: Descending nociceptive inhibitory pathways often malfunction in people with chronic pain. Conditioned pain modulation (CPM) is an experimental evaluation tool for assessing the functioning of these pathways. Spinal cord stimulation (SCS), a well-known treatment option for people with failed back surgery syndrome (FBSS), probably exerts its pain-relieving effect through a complex interplay of segmental and higher-order structures. Objective: To the best of our knowledge, no clinical studies have thoroughly investigated the associations between SCS and CPM. Design: This was a prospective cohort study in people with FBSS. Methods: Seventeen people who had FBSS and were scheduled for SCS were enrolled in this study. The CPM model was evaluated at both sural nerves and was induced by electrical stimulation as the test stimulus and the cold pressor test as the conditioning stimulus. Results: Before SCS, less than 30% of the participants with FBSS showed a CPM effect. Significant increases in the electrical detection threshold on the symptomatic side and the nonsymptomatic side were found. On the symptomatic side, no differences in the numbers of CPM responders before and after SCS could be found. On the nonsymptomatic side, more participants showed a CPM effect during SCS. Additionally, there were significant differences for CPM activation and SCS treatment. Limitations: Limitations were the small sample size and the subjective outcome parameters in the CPM model. Conclusions: This study revealed a bilateral effect of SCS that suggests the involvement of higher-order structures, such as the periaqueductal gray matter and rostroventromedial medulla (key regions in the descending pathways), as previously suggested by animal research. [ABSTRACT FROM AUTHOR]

To report on a less-invasive technique for replacing a broken lead in a spinal cord stimulation (SCS) device that makes use of St. Jude Medical’s “Epiducer” device. A 53-year-old woman suffered a loss of stimulation on her internal pulse generator (IPG), which was found to have a broken lead. The broken lead was withdrawn using the Epiducer device with minimal invasiveness and without pain. A new lead was put in place, and successful stimulation using the IPG resumed. Follow-up 3 weeks later showed a well-functioning SCS system. An Epiducer can be used to revise the SCS system in a minimal invasive way without a new puncture. Follow-up study of this technique as well as others for revising an SCS system should be encouraged and used in comparison study. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented regarding the case study of a 57-year-old woman who treated with HF10 therapy for chronic back pain with nonoperated kyphoscoliosis.

Introduction: The spinal cord is a target for many neurosurgical procedures used to treat chronic severe pain. Neuromodulation and neuroablation are surgical techniques based on well-known specific anatomical structures. However, anatomical and electrophysical changes related to the tethered spinal cord make it more difficult to use these procedures.Case Presentation: We report the case of a 37-year-old Caucasian woman who had several surgical interventions for tethered cord syndrome. These interventions resulted in severe neuropathic pain in her lower back and right leg. This pain was treated by spinal cord stimulation using intra-operative sensory mapping, which allowed the cord's optimal placement in a more caudal position.Conclusion: The low-voltage and more caudally placed electrodes are specific features of this treatment of tethered cord syndrome. [ABSTRACT FROM AUTHOR]

While paresthesia-based Spinal Cord Stimulation (SCS) has been proven effective as treatment for chronic neuropathic pain, its initial benefits may lead to the development of "Failed SCS Syndrome' (FSCSS) defined as decrease over time related to Loss of Efficacy (LoE) with or without Loss of Coverage (LoC). Development of technologies associating new paresthesia-free stimulation waveforms and implanted pulse generator adapters provide opportunities to manage patients with LoE. The main goal of our study was to investigate salvage procedures, through neurostimulation adapters, in patients already implanted with SCS and experiencing LoE. We retrospectively analyzed a cohort of patients who were offered new SCS programs/waveforms through an implanted adapter between 2018 and 2021. Patients were evaluated before and at 1-, 3-, 6- and 12-month follow-ups. Outcomes included pain intensity rating with a Visual Analog Scale (VAS), pain/coverage mappings and stimulation preferences. Last follow-up evaluations (N = 27) showed significant improvement in VAS (p = 0.0001), ODI (p = 0.021) and quality of life (p = 0.023). In the 11/27 patients with LoC, SCS efficacy on pain intensity (36.89%) was accompanied via paresthesia coverage recovery (55.57%) and pain surface decrease (47.01%). At 12-month follow-up, 81.3% preferred to keep tonic stimulation in their waveform portfolio. SCS conversion using adapters appears promising as a salvage solution, with an emphasis on paresthesia recapturing enabled via spatial retargeting. In light of these results, adapters could be integrated in SCS rescue algorithms or should be considered in SCS rescue. [ABSTRACT FROM AUTHOR]

While spinal cord stimulation (SCS) is a well-established therapy to address refractory persistent spinal pain syndrome after spinal surgery (PSPS-T2), its lack of spatial selectivity and reported discomfort due to positional effects can be considered as significant limitations. As alternatives, new waveforms, such as burst stimulation and different spatial neural targets, such as dorsal root ganglion stimulation (DRGS), have shown promising results. Comparisons between DRGS and standard SCS, or their combination, have never been studied on the same patients. "BOOST DRG" is the first prospective, randomized, double-blinded, crossover study to compare SCS vs. DRGS vs. SCS+DRGS. Sixty-six PSPS-T2 patients will be recruited internationally in three centers. Before crossing over, patients will receive each stimulation modality for 1 month, using tonic conventional stimulation. After 3 months, stimulation will consist in switching to burst for 1 month, and patients will choose which modality/waveform they receive and will then be reassessed at 6 and 12 months. In addition to our primary outcome based on pain rating, this study is designed to assess quality of life, functional disability, psychological distress, pain surface coverage, global impression of change, medication quantification, adverse events, brain functional imaging and electroencephalography, with the objective being to provide a multidimensional insight based on composite pain assessment. [ABSTRACT FROM AUTHOR]

New waveforms have changed the field of Spinal Cord Stimulation (SCS) to optimize therapy outcomes, among which is High-Dose SCS (HD-SCS). Missing observations are often encountered when conducting clinical trials in this field. In this study, different approaches with varying assumptions were constructed to evaluate how conclusions may be influenced by these assumptions. The aim is to perform a tipping point sensitivity analysis to evaluate the influence of missing data on the overall conclusion regarding the effectiveness of HD-SCS on disability. Data from the Discover study were used, in which 185 patients with Failed Back Surgery Syndrome were included. Disability was evaluated before SCS and after 1, 3 and 12 months of HD-SCS. During the second, third and fourth visit, data from 130, 114 and 90 patients were available, respectively. HD-SCS resulted in a significant decrease in disability scores based on the analysis of observed data and with multiple imputations. The tipping point sensitivity analysis revealed that the shift parameter was 17. Thus, the conclusion concerning the time effect under a "missing at random" mechanism is robust when the shift parameter for the disability score is 17. From a clinical point of view, a shift of 17 points on disability is not very plausible. Therefore we tend to consider the conclusions drawn under "missing at random" as being robust. [ABSTRACT FROM AUTHOR]

Persistent pain after spinal surgery can be successfully addressed by spinal cord stimulation (SCS). International guidelines strongly recommend that a lead trial be performed before any permanent implantation. Recent clinical data highlight some major limitations of this approach. First, it appears that patient outco mes, with or without lead trial, are similar. In contrast, during trialing, infection rate drops drastically within time and can compromise the therapy. Using composite pain assessment experience and previous research, we hypothesized that machine learning models could be robust screening tools and reliable predictors of long-term SCS efficacy. We developed several algorithms including logistic regression, regularized logistic regression (RLR), naive Bayes classifier, artificial neural networks, random forest and gradient-boosted trees to test this hypothesis and to perform internal and external validations, the objective being to confront model predictions with lead trial results using a 1-year composite outcome from 103 patients. While almost all models have demonstrated superiority on lead trialing, the RLR model appears to represent the best compromise between complexity and interpretability in the prediction of SCS efficacy. These results underscore the need to use AI-based predictive medicine, as a synergistic mathematical approach, aimed at helping implanters to optimize their clinical choices on daily practice. [ABSTRACT FROM AUTHOR]

Despite the well-known clinical effects of spinal cord stimulation (SCS), the mechanisms of action have not yet been fully unraveled. The primary aim of this study was to measure whether electrochemical skin conductance, as a measure of peripheral sympathetic autonomic function, is altered by SCS. A second aim was to compare skin conductance levels of patients with failed back surgery syndrome (FBSS) with age- and sex-matched healthy controls. Twenty-three patients with FBSS treated with SCS participated in this study. Sudomotor function was measured with the SudoscanTM instrument on the hands and feet during SCS on and off states. Difference scores in skin conductance between patients and age- and sex-matched healthy controls were calculated. Normal sudomotor function at the painful lower limb was revealed for 61% of the patients when SCS was activated. Skin conductance levels were not altered between on and off states of SCS. Differences in scores between patients and healthy controls were significantly different from zero. This study showed that SCS does not influencing the sympathetic nervous system in patients with FBSS, as measured by skin conductance levels. Moreover, it suggested that there is no normalization of the functioning of the sympathetic nervous system, despite the effectiveness of SCS to reduce pain intensity. [ABSTRACT FROM AUTHOR]

The increased awareness of discrepancies between self-reporting outcome measurements and objective outcome measurements within the field of neuromodulation has accelerated the search towards more objective measurements. The aim of this study was to evaluate whether an electronic nose can differentiate between chronic pain patients in whom Spinal Cord Stimulation (SCS) was activated versus deactivated. Twenty-seven patients with Failed Back Surgery Syndrome (FBSS) participated in this prospective pilot study. Volatile organic compounds in exhaled breath were measured with electronic nose technology (Aeonose™) during SCS on and off states. Random forest was used with a leave-10%-out cross-validation method to determine accuracy of discriminating between SCS on and off states. Our random forest showed an accuracy of 0.56, with an area under the curve of 0.62, a sensitivity of 62% (95% CI: 41–79%) and a specificity of 50% (95% CI: 30–70%). Pain intensity scores were significantly different between both SCS states. Our findings indicate that we cannot discriminate between SCS off and on states based on exhaled breath with the Aeonose™ in patients with FBSS. In clinical practice, these findings imply that with a noninvasive electronic nose, exhaled breath cannot be used as an additional marker of the effect of neuromodulation. [ABSTRACT FROM AUTHOR]

Despite the established efficacy and effectiveness of Spinal Cord Stimulation (SCS), there is still no consensus on the supraspinal mechanisms of action of this therapy. The purpose of this study was to systematically review previously raised hypotheses concerning supraspinal mechanisms of action of SCS based on human, animal and computational studies. Searches were conducted using four electronic databases (PubMed, EMBASE, SCOPUS and Web of Science), backward reference searching and consultation with experts. The study protocol was registered prior to initiation of the review process (PROSPERO CRD42020161531). A total of 54 publications were included, 21 of which were animal studies, and 33 were human studies. The supraspinal hypotheses (n = 69) identified from the included studies could be categorized into six groups concerning the proposed supraspinal hypothesis, namely descending pathways (n = 24); ascending medial pathway (n = 13); ascending lateral pathway (n = 10); affective/motivational influences (n = 8); spinal–cerebral (thalamic)-loop (n = 3) and miscellaneous (n = 11). Scientific support is provided for the hypotheses identified. Modulation of the descending nociceptive inhibitory pathways, medial and lateral pathways were the most frequently reported hypotheses about the supraspinal mechanisms of action of SCS. These hypotheses were mainly supported by studies with a high or moderate confidence in the body of evidence. [ABSTRACT FROM AUTHOR]

Despite the proven clinical value of spinal cord stimulation (SCS) for patients with failed back surgery syndrome (FBSS), factors related to a successful SCS outcome are not yet clearly understood. This study aimed to predict responders for high frequency SCS at 10 kHz (HF-10). Data before implantation and the last available data was extracted for 119 FBSS patients treated with HF-10 SCS. Correlations, logistic regression, linear discriminant analysis, classification and regression trees, random forest, bagging, and boosting were applied. Based on feature selection, trial pain relief, predominant pain location, and the number of previous surgeries were relevant factors for predicting pain relief. To predict responders with 50% pain relief, 58.33% accuracy was obtained with boosting, random forest and bagging. For predicting responders with 30% pain relief, 70.83% accuracy was obtained using logistic regression, linear discriminant analysis, boosting, and classification trees. For predicting pain medication decrease, accuracies above 80% were obtained using logistic regression and linear discriminant analysis. Several machine learning techniques were able to predict responders to HF-10 SCS with an acceptable accuracy. However, none of the techniques revealed a high accuracy. The inconsistent results regarding predictive factors in literature, combined with acceptable accuracy of the currently obtained models, might suggest that routinely collected baseline parameters from clinical practice are not sufficient to consistently predict the SCS response with a high accuracy in the long-term. [ABSTRACT FROM AUTHOR]

Abstract: The use of high-dose spinal cord stimulation (HD-SCS) has increased drastically during the past few years, with positive results. However, there remains a deficit of real-world data of the effectiveness of HD-SCS. Therefore, the primary aim was to evaluate the effectiveness of HD-SCS in patients with failed back surgery syndrome (FBSS). The second aim was to develop a prediction model for a holistic responder. One hundred ninety-four patients were recruited to a multicenter real-world registry. Self-reporting outcome variables were evaluated at baseline (before SCS) and at 1, 3, and 12 months of HD-SCS implant. Outcome measures were the mean pain intensity over time, sleep quality, disability, health-related quality of life, and medication use. Besides the effectiveness, logistic regression and decision tree analysis were performed to define a holistic responder (pain intensity reduction, medication reduction, Oswestry disability index reduction, and EQ5D improvement) after 12 months of HD-SCS. Of 185 FBSS patients who underwent a baseline visit, 75.13% had a successful HD trial. At 12 months, 92 patients were still receiving HD-SCS. Both low back and leg pain significantly decreased at 12 months. All outcome measures revealed a significant time-dependent effect from baseline to 12 months. Holistic responders could be predicted with a sensitivity and specificity of 90%. Clinically significant and sustained pain relief over a period of 12 months was achieved with HD-SCS in patients with FBSS. In addition, HD-SCS also achieved an improvement in sleep quality, functionality, and a decrease in pain medication. [ABSTRACT FROM AUTHOR]

• Exploration of structural volumetric brain changes due to subsensory SCS. • Gray and white matter volumetric changes were observed in failed back surgery syndrome. • This study confirmed supraspinal effects of SCS in this population. Despite the clinical effectiveness of Spinal Cord Stimulation (SCS), potential structural brain modifications have not been explored. Our aim was to identify structural volumetric changes during subsensory SCS, in patients with Failed Back Surgery Syndrome (FBSS). In this cohort study, twenty-two FBSS patients underwent a magnetic resonance imaging protocol before SCS and 3 months after SCS. Clinical parameters were correlated with volumetric changes, calculated with voxel-based morphometry. After 3 months, a significant volume decrease was found in the inferior frontal gyrus, precuneus, cerebellar posterior lobe and middle temporal gyrus. Significant increases were found in the inferior temporal gyrus, precentral gyrus and the middle frontal gyrus after SCS. Additionally, significant increases in volume of superior frontal and parietal white matter and a significant decrease in volume of white matter underlying the premotor/middle frontal gyrus were revealed after SCS. A significant correlation was highlighted between white matter volume underlying premotor/middle frontal gyrus and leg pain relief. This study revealed for the first time that SCS is able to induce volumetric changes in gray and white matter, suggesting the reversibility of brain alterations after chronic pain treatment. Volumetric brain alterations are observable after 3 months of subsensory SCS in FBSS patients. [ABSTRACT FROM AUTHOR]