Neuromodulation最新文献

{"title":"Pulsed Shortwave (Radiofrequency) Therapy With a Noninvasive, Wearable, Disposable Device: A Randomized, Participant- and Assessor-Masked, Sham-Controlled Pilot Study.","authors":"Brian M Ilfeld, John J Finneran, Engy T Said, Scott T Ball, Bryan J Sandler, Ryan C Broderick, Francis B Gonzales, Nathan J Lau, Adam Schaar, Baharin Abdullah","doi":"10.1016/j.neurom.2025.01.008","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.01.008","url":null,"abstract":"<p><strong>Objectives: </strong>Pulsed shortwave therapy (PSWT) is a nonpharmacologic/noninvasive modality that may offer analgesic benefits without notable side effects or complications. This pilot study aimed to assess the feasibility of a PSWT protocol and provide an estimate of its treatment effects.</p><p><strong>Materials and methods: </strong>The study included adults who underwent cholecystectomy or unilateral total hip or knee arthroplasty. Participants were randomized to eight days of either PSWT with a single functioning device (SofPulse, Endonovo Therapeutics, Woodland Hills, CA) or a sham device placed over the surgical bandages in a participant- and assessor-masked fashion. The primary end point was the sum of the average and worst (maximum) daily pain intensity as measured with the numeric rating scale collected over the first seven postoperative days.</p><p><strong>Results: </strong>No systemic side effects or significant complications occurred. During the first seven postoperative days, the sum of the daily pain intensity scores in the active group was a mean (SD) of 28 (11) vs 34 (14) in sham: difference -6.5 (95% CI, -12.4 to -0.6), p = 0.032. During the same period, cumulative oxycodone consumption in the active group was a mean (SD) of 4.6 (4.9) mg vs 5.1 (7.3) mg in sham: difference -0.5 (95% CI, -3.4 to 2.5), p = 0.761. Subgroup analysis suggested that the analgesic effect for knee arthroplasty was greater than for the other surgical procedures.</p><p><strong>Conclusions: </strong>PSWT is feasible for inpatients and outpatients, and reduced pain over the first postoperative week. These results are preliminary and should be replicated with a subsequent study before being considered definitive. Although this pilot study was inadequately powered to conclusively identify statistically significant differences between treatments for the secondary end points, if the analgesic improvements are successfully replicated in a definitive trial, they would meet or exceed the benefits identified for oral acetaminophen. Data from this pilot study may be used to help plan future trials.</p><p><strong>Clinical trial registration: </strong>The Clinicaltrials.gov registration number for the study is NCT05796583.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of an Educational Curriculum for Implanting and Managing Vagus Nerve Stimulators for Epilepsy.","authors":"David Bieber, Kunal Gupta, Rany Abdallah, Alaa Abd-Elsayed, Alyson Engle, Irina Duff, Duvan Hoffman, Hemant Kalia, Joshua Rosenow, Micheal Macken, Ahmed M Raslan, Konstantin Slavin, Amy Tennant, Jeffrey S Raskin","doi":"10.1016/j.neurom.2024.12.008","DOIUrl":"https://doi.org/10.1016/j.neurom.2024.12.008","url":null,"abstract":"<p><strong>Background: </strong>Vagus nerve stimulation (VNS) devices are commonly used for extracranial neuromodulation of drug-resistant epilepsy. These devices are implanted by multiple surgical subspecialties and managed by practitioners with varying levels of epilepsy-specific expertise. The North American Neuromodulation Society (NANS) education committee presents a curriculum defining level-dependent recommendations within the six-core competency rubric for the implantation and management of VNS devices.</p><p><strong>Material and methods: </strong>A multidisciplinary (anesthesiology, neurology, neurosurgery, and physiatrists) and diverse (advanced practice providers, physicians, and surgeons) subcommittee of the NANS education committee met virtually over a year to develop a curriculum following the Accreditation Council for Graduate Medical Education (ACGME) core competencies. The subcommittee used a consensus approach, evidence-based development strategy; once completed, the VNS curriculum was approved by the NANS board.</p><p><strong>Results: </strong>The subcommittee developed a VNS curriculum as a standard to be used for implanting surgeons, managing physicians, and advanced practice providers. The vertical orientation of the curriculum uses the ACGME educational core competencies framework; within this paradigm is a horizontal progression of skills with distinct competency groups for implanting surgeons and/or managing physicians. The horizontal progression defines the expected competence for early learner, advanced learner, and independent practitioner.</p><p><strong>Conclusion: </strong>A NANS education subcommittee iteratively developed a VNS curriculum for defining progressive competence of myriad care providers, including clinicians and advanced practice providers, within the ACGME six core competencies.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Is There a Correlation Between Objective Measurement Tools and Self-Reporting Questionnaires To Evaluate Physical Activity and Health Status in Patients With Persistent Spinal Pain Syndrome Type 2 Before and After Spinal Cord Stimulation? Outcomes of a Feasibility Study.","authors":"Tanja E Hamm-Faber, Kris C P Vissers, Ewald Bronkhorst, Inge Arnts, Ismail Gültuna, Frank G A M van Haren, Carin A G L Wensing, Yvonne Engels, Dylan J H A Henssen","doi":"10.1016/j.neurom.2025.01.007","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.01.007","url":null,"abstract":"<p><strong>Introduction: </strong>The effect of spinal cord stimulation (SCS) on physical activity in patients with persistent spinal pain syndrome (PSPS) type 2 is commonly evaluated with standardized, validated self-reporting questionnaires. However, questionnaires are susceptible to subjective bias and may not align with objective data.</p><p><strong>Objective: </strong>We investigated the correlation among objective measurement devices, the Oswestry Disability Index (ODI), and patient's health status regarding physical activity in patients with PSPS type 2 receiving SCS.</p><p><strong>Materials and methods: </strong>Alongside the ODI, we used an activity tracker to objectively measure physical activity and a neurostimulator device to objectively measure body positions at baseline and three-month follow-up. In addition, health status was measured using the positive model of health.</p><p><strong>Results: </strong>We included 20 patients, of whom 17 completed the three-month follow-up period. At three months follow-up, we found a significant correlation between the activity tracker's steps (r = -0.636, p = 0.006) and distance per day (r = -0.649, p = 0.005) with the ODI and a significant correlation of the neurostimulator's mobile position with the ODI (r = -0.497, p = 0.043). Furthermore, the activity tracker showed a significant increase in strenuous physical activity at three-month follow-up (p = 0.039). We also observed a substantial improvement across the domains of bodily function, social and societal participation, and daily functioning of the positive model of health.</p><p><strong>Conclusions: </strong>This study showed significant correlations among objective measurement devices, the ODI, and health status, which could contribute to a more holistic approach to evaluating the effect of SCS. Prospective powered studies with a control group are needed to better understand this area.</p><p><strong>Clinical trial registration: </strong>The protocol was registered in the Dutch Trial Register (NTR) on March 13, 2021 under registration number NL 9301 (number NL-OMON21829).</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incidence of Lead Tip Fracture and Retention After Percutaneous Lead Implantation for Peripheral Nerve Stimulation With an External Pulse Generator: A Multicenter Comparative Analysis of 456 Lead Implants Across Two Lead Hardware Generations.","authors":"Chelsey Hoffmann, Kalli J Fautsch, Ryan S D'Souza","doi":"10.1016/j.neurom.2025.01.009","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.01.009","url":null,"abstract":"<p><strong>Objectives: </strong>Lead fracture and retention are potential adverse events that can occur after peripheral nerve stimulator (PNS) lead implantation, although recent technologic advancements in PNS hardware have been implemented to avert this risk. We aim to quantify the current incidence of temporary PNS lead fracture/retention and compare this with rates before changes in lead hardware design of temporary PNS.</p><p><strong>Materials and methods: </strong>A multicenter, retrospective observational study was conducted for patients implanted with a temporary PNS system (SPR© Therapeutics, Cleveland, OH) between June 1, 2018 and August 1, 2024. Patients were included if they underwent a temporary percutaneous PNS system implantation with planned lead removal at 60 days. Patients were excluded if there was ambiguity regarding the status of the lead tip at time of removal (intact vs fractured) or if there was inadvertent lead removal by the patient during the 60-day treatment. The primary objectives of this study were 1) to quantify the incidence of lead retention with removal of temporary percutaneous PNS and 2) to compare the rates of lead retention in the original lead design (version 1.0) and the revised lead design (version 2.0). Secondary objectives included analysis of lead retention rates based on the following covariates: body mass index (BMI), patient age, location of lead placement, or duration of lead implant.</p><p><strong>Results: </strong>Within the studied timeframe, 337 patients were implanted with a total of 456 leads. Of 337 patients, 40.4% (n = 136) were implanted with lead version 1.0, and 59.6% (n = 201) were implanted with lead version 2.0. Overall, 7.5% of implanted leads (34/456) were retained, affecting 10.1% of patients. Of 194 implanted version 1.0 leads, 13.4% of leads (n = 26) were retained, whereas of 262 version 2.0 leads, 3.1% (n = 8) were retained (p < 0.001). These results showed a reduction in retained leads per patient from 19.1% with lead version 1.0 to 4.0% with revised lead version 2.0. Covariates including BMI, patient age, location of lead placement, or duration of lead implant did not predict lead retention rates.</p><p><strong>Conclusions: </strong>Retention and fracture of temporary PNS leads remain prevalent, affecting 7.5% of all implanted leads, although we also observed a significant decrease in rates (3.1% vs 13.4%) with implementation of the revised lead version 2.0 hardware design.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Electroacupuncture at ST36 Relieves Visceral Hypersensitivity Based on the Vagus-Adrenal Axis in the Remission Stage of Ulcerative Colitis.","authors":"Mingwei Fan, Tan Chen, Jinlan Tian, Can Zhang, Zijian Zhao, Xinru Liu, Shuhui Zhang, Yan Chen","doi":"10.1016/j.neurom.2024.12.006","DOIUrl":"https://doi.org/10.1016/j.neurom.2024.12.006","url":null,"abstract":"<p><strong>Background and aims: </strong>Although electroacupuncture (EA) at ST36 has been shown to alleviate visceral hypersensitivity in rats with ulcerative colitis (UC), the exact mechanism remains unknown. This study aims to investigate whether EA can effectively inhibit the activity of enteric glial cells (EGCs) through the adrenergic antiinflammatory pathway and thereby attenuate visceral hypersensitivity in rats with UC in remission.</p><p><strong>Materials and methods: </strong>Sprague-Dawley rats were continuously fed 5% dextran sulfate sodium (DSS) for seven days to establish intestinal inflammation. After seven days of remission, rats underwent EA (n = 6, 100 Hz, 1 mA, one hour) or sham EA (n = 6) for 14 days. A normal control group (n = 6) received no treatment. Inflammation was assessed using disease activity index (DAI) inflammatory cytokines. Visceral sensitivity was examined weekly by abdominal withdrawal reflexes (AWR) score. We used the enzyme-linked immunosorbent assay method to measure levels of norepinephrine (NE) in serum after EA. The expression of EGCs, levels of inflammatory cytokine S100 calcium-binding protein β (S100β), and associated pathway proteins receptor for advanced glycosylation end-products (RAGE), myeloid differentiation factor 88 (MyD88), and nuclear factor-κ B (NF-κB) in the colon were assessed using immunofluorescence staining and Western blotting.</p><p><strong>Results: </strong>The Model group exhibited elevated DAI scores, shortened colon, and increased inflammatory cytokines; the EA group showed significant relief of symptoms. The Model group exhibited elevated visceral hypersensitivity, which resolved after 14 days of EA treatment. The EA group exhibited higher NE levels than did the Model group. Compared with the Model group, the expression of EGCs in the colonic submucosa was reduced in the EA group, and the expression of S100β, RAGE, MyD88, and NF-κB proteins were downregulated.</p><p><strong>Conclusion: </strong>This study suggests that EA potentially reduces visceral hypersensitivity in UC by decreasing the activity of EGCs and the release of S100β through noradrenergic pathway.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Two Different Neuromodulation Treatments in Patients With Acute Zoster-Related Trigeminal Neuropathic Pain and Pain Catastrophizing.","authors":"Chengwen Wu, Qi Zhou, Yue Zhang, Changhe Ren, Cehua Ou","doi":"10.1016/j.neurom.2025.01.010","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.01.010","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed to compare the efficacy of two neuromodulation techniques, peripheral nerve stimulation (PNS) and pulsed radiofrequency (PRF), in patients with acute zoster-related trigeminal neuropathic pain with pain catastrophizing.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Materials and methods: &lt;/strong&gt;A total of 65 patients with acute zoster-related trigeminal neuropathic pain and pain catastrophizing were recruited from the Department of Pain Management of the Affiliated Hospital of Southwest Medical University between March 2019 and March 2024. According to the order of enrollment, participants were randomly assigned to two groups: the PNS group (n = 31), which received stimulation of the supraorbital nerve, and the PRF group (n = 34), which underwent PRF treatment of the same nerve. Pain levels were assessed using a visual analog scale (VAS), and the dosage of the anticonvulsant pregabalin was recorded at baseline, one week, two weeks, one month, three months, and six months postoperatively. Additionally, patients were evaluated using the Pain Catastrophizing Scale (PCS) and the Short Form 36 (SF-36) Health Survey at baseline and one, three, and six months postoperatively. Both groups were also monitored for adverse events and patient satisfaction throughout the study period.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Both the PNS and PRF groups experienced significant pain relief. However, the PNS group demonstrated superior outcomes compared with the PRF group at both short-term follow-up time points (p &lt; 0.05). No significant difference in VAS scores was observed between the PNS and PRF groups during the long-term (six-month) follow-up. Improvements were noted in the SF-36 (across all eight dimensions) and PCS scores in both groups following treatment (p &lt; 0.05). Notably, the PCS scores in the PNS group were consistently lower than those in the PRF group at all follow-up time points (p &lt; 0.05). Additionally, patients in the PNS group exhibited greater improvements in physical role limitations, somatic pain, general health, social functioning, emotional role limitations, and mental health compared with those in the PRF group (p &lt; 0.05). There were no significant differences between the two groups regarding improvements in physical functioning and vigor. After treatment, the average daily dose of pregabalin (mg/d) was reduced in both groups, with patients in the PNS group requiring a lower dose than those in the PRF group. Furthermore, patients in the PNS group reported a significantly higher level of satisfaction (p &lt; 0.05) based on satisfaction evaluations. No instances of bleeding, infection, or other adverse effects were observed in either group after treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Both PNS and PRF are effective and feasible for managing pain in patients with acute zoster-related trigeminal neuropathic pain and pain catastrophizing. However, PNS demonstrates superior efficacy in terms of early pain relief, reduction of pain","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tonic and Event-Related Phasic Transcutaneous Auricular Vagus Nerve Stimulation Alters Pupil Responses in the Change-Detection Task.","authors":"Jingxin Chen, Yufeng Ke, Guangjian Ni, Shuang Liu, Dong Ming","doi":"10.1016/j.neurom.2025.01.003","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.01.003","url":null,"abstract":"<p><strong>Background: </strong>Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a potential modulator of cognitive behavior that activates the locus coeruleus-noradrenaline (LC-NA) system. Previous studies explored both phasic and tonic taVNS by investigating their impact on LC-NA markers such as pupil dilation and heart rate variability (HRV).</p><p><strong>Objective: </strong>Inconsistencies persist in the identification of reliable markers for assessing the effects of taVNS on noradrenergic activity. Furthermore, it remains unclear whether the effects of taVNS extend beyond pure vagal nerve responses, particularly in specific cognitive domains such as working memory. In the present study, we investigated the effects of taVNS on working memory capacity and LC-NA markers using a change-detection task.</p><p><strong>Materials and methods: </strong>Twenty-two healthy, right-handed university students participated in a sham-controlled, randomized cross-over experiment with four sessions. We applied two types of phasic and event-related stimulation (Pre-event and Event-synchronous), tonic stimulation (Pre-task), and sham stimulation across different sessions. Pupil size and electrocardiogram data were recorded during the tasks.</p><p><strong>Results: </strong>taVNS did not significantly modulate behavioral performance on the change-detection task, specifically working memory capacity. However, both tonic and event-related phasic taVNS significantly influenced the pupillary response during the task. In addition, the Pre-task condition of the taVNS affected the low-frequency parameter of HRV.</p><p><strong>Conclusions: </strong>Our findings suggest that tonic and event-related phasic taVNS may modulate noradrenergic activity, as evidenced by pupil responses and HRV changes during the change-detection task. This study provides new evidence regarding the impact of taVNS on cognitive tasks, thus supporting the development of noninvasive neuromodulation interventions.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382764","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect and Mechanism of Vagal Nerve Stimulation on Gastric Motility: A Preliminary Rodent Study.","authors":"Shiying Li, Feng Ye, Sujuan Zhang, Yi Liu, Jiande D Z Chen","doi":"10.1016/j.neurom.2024.12.005","DOIUrl":"https://doi.org/10.1016/j.neurom.2024.12.005","url":null,"abstract":"<p><strong>Background: </strong>Patients with functional dyspepsia often exhibit gastrointestinal motor disorders associated with gastric myoelectrical dysrhythmia. This study investigated the effects of vagal nerve stimulation (VNS) in a rodent model of gastric slow-wave dysrhythmia induced by colorectal distention (CRD).</p><p><strong>Materials and methods: </strong>Male Sprague-Dawley rats were implanted with wires in the gastric body to record gastric slow waves and in the left cervical vagal nerve for stimulation. VNS was conducted over six sessions to optimize its efficacy on CRD-induced gastric dysrhythmia: control, CRD, and CRD with four different sets of parameters varying in frequency and stimulation on/off times. Both the CRD and VNS were conducted throughout the recording after the meal. Atropine was administered in two additional sessions, with or without VNS, to explore the involvement of the cholinergic pathway. The percentage of postprandial normal gastric slow waves (NSW), defined as the percentage of time during which the gastric slow wave was normal, was quantified using adaptive spectral analysis.</p><p><strong>Results: </strong>The study findings were 1) CRD significantly reduced the percentage of NSW from 89.2% ± 1.6% to 64.3% ± 3.5% (p < 0.001), which was mitigated by VNS at 14 Hz (83.5% ± 3.0%, p < 0.001) and 25 Hz (88.4% ± 1.7%, p < 0.001); 2) atropine slightly, but not significantly, decreased the percentage of NSW to 54.1% ± 3.2% and abolished the beneficial effects of VNS at 25 Hz on gastric slow waves (60.9% ± 3.3%, p < 0.01); and 3) CRD delayed gastric emptying, which was restored by 25 Hz VNS.</p><p><strong>Conclusion: </strong>VNS using optimal parameters effectively ameliorated CRD-induced gastric dysmotility mediated through the vagal-cholinergic pathway, suggesting that VNS may hold therapeutic potential for functional gastrointestinal disorders.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143365059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Opinion of Healthcare Professionals About a Proposed European Registry of Neuromodulation for Chronic Pain: An Online Survey","authors":"Lisa Goudman PhD, MSc ,&nbsp;Philippe Rigoard MD, PhD ,&nbsp;Manuel Roulaud MSc ,&nbsp;Konstantin Slavin MD ,&nbsp;Marc Russo MBBS ,&nbsp;Maxime Billot PhD ,&nbsp;Maarten Moens MD, PhD","doi":"10.1016/j.neurom.2024.08.009","DOIUrl":"10.1016/j.neurom.2024.08.009","url":null,"abstract":"<div><h3>Introduction</h3><div>During the last decade, the complementary value of real-world data (through registries or medical records) and data from randomized clinical trials has been recognized as increasingly important. In the field of neuromodulation, only a few industry-independent nationwide neuromodulation registries are available. The interest in creating a European registry has increased but without a successful result. The goal of this online survey is to gain further insights into the need for and burden of a European registry for neuromodulation.</div></div><div><h3>Materials and Methods</h3><div>An online survey was developed and distributed during the 3rd Joint Congress of the International Neuromodulation Society European Chapters in September 2023 (Hamburg, Germany). Healthcare professionals were asked to indicate the need for a European registry, the items that should be collected, and the restrictions to access of a European registry.</div></div><div><h3>Results</h3><div>In total, 125 respondents opened the link to the survey, of whom 104 completed (at least partly) the survey. Of the 104 responses, 91% indicated that there is a need for a European registry, whereas 6% indicated there is no need. The main reasons for establishing a registry on a European level were the possibility of collecting real-world evidence (84%), the potential to collect big data from European patients (82%), to evaluate safety in neuromodulation (70%), and the possibility of reporting yearly on European activity in neuromodulation (51%). Indications for neuromodulation, patient characteristics, and follow-up assessments were most often stated as items that should be collected. Access should not only be granted to implanters but also to nurses, the assessment team, and other physicians, as agreed on by 64%, 52%, and 51%, respectively.</div></div><div><h3>Discussion</h3><div>More than 90% of the respondents believed that a European registry for neuromodulation is needed, mainly to obtain real-world (big) data about the effectiveness and safety of this therapy. This survey clearly pointed to the need for a European registry for which it seems key to ensure financial and logistical support, in addition to in-depth legal guidance in developing this registry.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 2","pages":"Pages 362-368"},"PeriodicalIF":3.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142350819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preoperative Magnetic Resonance Imaging Modifies Percutaneous Spinal Cord Stimulator Trial Progression and Planning","authors":"David A. Provenzano MD ,&nbsp;Esha A. Vaidya BA ,&nbsp;Jason S. Kilgore PhD","doi":"10.1016/j.neurom.2024.10.005","DOIUrl":"10.1016/j.neurom.2024.10.005","url":null,"abstract":"<div><h3>Objective</h3><div>Spinal cord stimulator (SCS) percutaneous lead placement has been effective in treating chronic limb, neck, and back pain. However, SCS lead placement poses a risk of neurologic injury, which may be attenuated with preprocedural magnetic resonance imaging (MRI) to identify potential spinal anatomical abnormalities (eg, central canal stenosis) that would either modify or prevent lead placement. However, a large-scale study of the clinical value of preoperative MRIs in percutaneous SCS lead placement is lacking.</div></div><div><h3>Materials and Methods</h3><div>A retrospective chart review of a single center identified patients who considered SCS percutaneous lead trials and had preprocedural MRIs. Patients’ preprocedural MRIs were reviewed for spinal pathology and locations and severity of stenoses (mild, moderate, and severe) based on qualitative analysis that may affect lead placement. In addition, trial-related information and several demographic factors were analyzed with proportional analyses, logistic regressions, and relative risks (RR) to determine their association with stenosis.</div></div><div><h3>Results</h3><div>Retrospective review identified 340 patients who considered an SCS trial with preprocedural MRIs. Preprocedural MRIs influenced SCS treatment for 7% of total patients (<em>n</em> = 25). Of these 25 patients, 60% (<em>n</em> = 15) had the trial technique altered, and 40% (<em>n</em> = 10) did not progress to trial owing to an MRI finding. Preprocedural MRIs were more likely to influence SCS trials for cervical cases than for thoracic/lumbar cases (RR = 4.6, 95% CI 2.2–9.5, <em>p</em> &lt; 0.001). Clinical and demographic characteristics were associated with limited predictive capabilities for spinal stenosis. Specifically, logistic regression analyses revealed age group to be significantly (<em>p</em> ≤ 0.02) associated with moderate/severe cervical spinal stenosis and lumbar spinal stenosis, whereas only age was significantly (<em>p</em> ≤ 0.04) associated with moderate/severe thoracic spinal stenosis.</div></div><div><h3>Conclusion</h3><div>Preprocedural MRIs did influence SCS trial progression. Given limited patient characteristics were significantly associated with a greater risk of stenosis at lead placement or entry zones, all patient populations should be considered for preprocedural MRIs examining lead entry and placement zones.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 2","pages":"Pages 306-314"},"PeriodicalIF":3.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}