NeuromodulationPub Date : 2025-06-01DOI: 10.1016/j.neurom.2025.01.008
Brian M. Ilfeld MD, MS (Clinical Investigation) , John J. Finneran IV MD , Engy T. Said MD , Scott T. Ball MD , Bryan J. Sandler MD , Ryan C. Broderick MD , Francis B. Gonzales MD , Nathan J. Lau BS , Adam Schaar MD , Baharin Abdullah MD
{"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 MD, MS (Clinical Investigation) , John J. Finneran IV MD , Engy T. Said MD , Scott T. Ball MD , Bryan J. Sandler MD , Ryan C. Broderick MD , Francis B. Gonzales MD , Nathan J. Lau BS , Adam Schaar MD , Baharin Abdullah MD","doi":"10.1016/j.neurom.2025.01.008","DOIUrl":"10.1016/j.neurom.2025.01.008","url":null,"abstract":"<div><h3>Objectives</h3><div>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.</div></div><div><h3>Materials and Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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), <em>p</em> = 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), <em>p</em> = 0.761. Subgroup analysis suggested that the analgesic effect for knee arthroplasty was greater than for the other surgical procedures.</div></div><div><h3>Conclusions</h3><div>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.</div></div><div><h3>Clinical Trial Registration</h3><div>The <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> registration number for the study is NCT05796583.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 4","pages":"Pages 682-689"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","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}
NeuromodulationPub Date : 2025-05-30DOI: 10.1016/j.neurom.2025.04.004
Anu Kansal, Sue Copley, Rui V Duarte, Fiona C Warren, Rod S Taylor, Sam Eldabe
{"title":"Systematic Review to Identify Patient-Level Predictors of Treatment Response to Spinal Cord Stimulation for Neuropathic Pain for Studies Published From 2012 to 2024.","authors":"Anu Kansal, Sue Copley, Rui V Duarte, Fiona C Warren, Rod S Taylor, Sam Eldabe","doi":"10.1016/j.neurom.2025.04.004","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.04.004","url":null,"abstract":"<p><strong>Objective: </strong>Chronic neuropathic pain is challenging to manage, but one recommended treatment is spinal cord stimulation (SCS), which may provide pain relief and improvements in physical function and health-related quality of life. Almost half of the patients do not obtain long-term relief, and selection of appropriate patients can be problematic. The objective of this study was to undertake a systematic review of the contemporary evidence base for patient-level predictors for the outcomes from all types of SCS.</p><p><strong>Materials and methods: </strong>A literature search of MEDLINE, EMBASE, CINAHL, and WikiStim was conducted to identify contemporary SCS studies published from 2012 to 2024. Study selection, data extraction, and risk-of-bias (RoB) assessment using the Quality in Prognosis Studies tool were performed by two independent reviewers.</p><p><strong>Results: </strong>A total of 40 studies were included in the review; 28 studies (70%) had high RoB; seven (17.5%) had medium RoB, and five (12.5%) had low RoB. We found no strong evidence of an association between the studied patient-level factors and treatment outcomes, with conflicting results for most patient factors. Confidence in the evidence is limited because the quality of the assessed evidence ranged from low to very low, with a high RoB for most of the included studies.</p><p><strong>Conclusion: </strong>Access to individual patient data and prospective data collection including the use of large real-world registries with full population inclusion is required to identify potential patient-level factors, thus facilitating future patient selection and enhancing treatment outcomes.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144192045","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}
NeuromodulationPub Date : 2025-05-29DOI: 10.1016/j.neurom.2025.05.006
Cyril Atkinson-Clement, Mohammad Alkhawashki, Marilyn Gatica, Stefanos Alexandros Kontogouris, Marcus Kaiser
{"title":"Erratum to 'Delay- and Pressure-Dependent Neuromodulatory Effects of Transcranial Ultrasound Stimulation': [Neuromodulation: Technology at the Neural Interface, Volume 28, Issue 3, April 2025, Pages 444-454].","authors":"Cyril Atkinson-Clement, Mohammad Alkhawashki, Marilyn Gatica, Stefanos Alexandros Kontogouris, Marcus Kaiser","doi":"10.1016/j.neurom.2025.05.006","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.05.006","url":null,"abstract":"","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144187434","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}
NeuromodulationPub Date : 2025-05-27DOI: 10.1016/j.neurom.2025.03.080
Tim Ho, Michelle O'Brien, Richard Sullivan, Jane Standen, Andrew D H Weiss, Dan Bates, John Salmon, Nick Christelis, James Yu, Murray Taverner, Marc Russo
{"title":"Best Practice Guidelines for Neuromodulation in Pain Management: Insight From the Neuromodulation Society of Australia and New Zealand.","authors":"Tim Ho, Michelle O'Brien, Richard Sullivan, Jane Standen, Andrew D H Weiss, Dan Bates, John Salmon, Nick Christelis, James Yu, Murray Taverner, Marc Russo","doi":"10.1016/j.neurom.2025.03.080","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.03.080","url":null,"abstract":"<p><strong>Objectives: </strong>The Neuromodulation Society of Australia and New Zealand (NSANZ) developed evidence-based best practice guidelines for spinal cord stimulation (SCS) in chronic pain management. The primary objective was to provide clear guidance to support evidence-informed care across Australia and New Zealand, with a focus on patient selection, procedural techniques, and complication management.</p><p><strong>Materials and methods: </strong>A systematic literature review was conducted using Medline, EMBASE, Trip Pro, and Google Scholar, covering publications from 2010 to July 2024. A total of 283 studies and relevant clinical guidelines were included on the basis of level 1B evidence or strong expert consensus, consistent with the Grading of Recommendations Assessment, Development, and Evaluation criteria. Clinical questions were developed using the Population, Intervention, Comparison, and Outcome framework, and a Delphi process was used to achieve consensus among NSANZ board members.</p><p><strong>Results: </strong>The guidelines provide comprehensive recommendations on patient selection, preparation, procedural techniques, postimplantation care, and complication management. Additional guidance is included on training standards, quality improvement processes, and the importance of multidisciplinary collaboration. Key recommendations emphasize optimizing patient selection, enhancing procedural safety, and improving treatment outcomes.</p><p><strong>Conclusions: </strong>These guidelines offer practical, evidence-informed recommendations for the safe and effective use of SCS in chronic pain management. By promoting consistency, transparency, and collaborative care, they aim to guide clinical decision-making and support the delivery of evidence-informed neuromodulation services across Australia and New Zealand.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144160647","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}
NeuromodulationPub Date : 2025-05-27DOI: 10.1016/j.neurom.2025.04.005
Amir-Homayun Hallajian, Fateme Dehghani-Arani, Sepehr Sima, Amirmahdi Heydari, Kiomars Sharifi, Yasamin Rahmati, Reza Rostami, Zahra Vaziri, Mohammad Ali Salehinejad
{"title":"Theta-Burst Stimulation of the Right Temporoparietal Junction and Implicit Theory of Mind in Autism.","authors":"Amir-Homayun Hallajian, Fateme Dehghani-Arani, Sepehr Sima, Amirmahdi Heydari, Kiomars Sharifi, Yasamin Rahmati, Reza Rostami, Zahra Vaziri, Mohammad Ali Salehinejad","doi":"10.1016/j.neurom.2025.04.005","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.04.005","url":null,"abstract":"<p><strong>Objectives: </strong>Theory of mind (ToM), or mentalizing, is the ability to attribute mental states to oneself and others and is altered in individuals with autism spectrum disorder (ASD). Recent evidence suggests that implicit rather than explicit ToM is impaired in individuals with ASD. The right temporoparietal junction (rTPJ), which plays a crucial role in ToM, has altered activity in ASD and is a potential terget by noninvasive brain stimulation.</p><p><strong>Materials and methods: </strong>In a randomized single-blind placebo-controlled study, we investigated, for what we believe is the first time, the effects of theta-burst stimulation of the rTPJ on implicit ToM and egocentric bias in 17 adolescents with ASD. Participants (mean age = 13.84 ± 3.32 years) were randomly assigned to three sessions of continuous theta-burst stimulation (cTBS), intermittent theta-burst stimulation (iTBS), and sham stimulation in a counterbalanced order. Stimulation intensity was set to 80% of the active motor threshold during cTBS and iTBS, with the coil centered on the rTPJ (CP6). Immediately after each stimulation, cognitive correlates of ToM, including implicit mentalizing and egocentric bias, were evaluated using the computerized Buzz-lightyear task.</p><p><strong>Results: </strong>Both cTBS and iTBS significantly improved implicit ToM compared with sham stimulation, with cTBS yielding a numerically larger effect (379.2 milliseconds) than did iTBS (191.3 milliseconds), although this difference was not statistically significant. No effect was found on the egocentric bias index.</p><p><strong>Conclusions: </strong>These findings show a causal link between the rTPJ activation and implicit mentalizing in ASD, suggesting that theta-burst stimulation of this region can be used to enhance ToM in ASD. Targeting the rTPJ may improve implicit mentalizing in ASD and other disorders with impaired ToM.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144160696","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}
NeuromodulationPub Date : 2025-05-21DOI: 10.1016/j.neurom.2025.04.007
Michael Jigo, Jason B Carmel, Qi Wang, Charles Rodenkirch
{"title":"Transcutaneous Cervical Vagus Nerve Stimulation Improves Speech Comprehension in Noise: A Crossover, Placebo-Controlled Study.","authors":"Michael Jigo, Jason B Carmel, Qi Wang, Charles Rodenkirch","doi":"10.1016/j.neurom.2025.04.007","DOIUrl":"10.1016/j.neurom.2025.04.007","url":null,"abstract":"<p><strong>Background: </strong>Speech comprehension in noisy environments remains a significant challenge, even among individuals with clinically normal hearing and users of hearing aids and cochlear implants. Although conventional assistive hearing devices address limitations in the auditory periphery, they do not directly enhance the brain's capacity to segregate speech from background noise. Because tonic vagus nerve stimulation (VNS) has shown potential for rapidly improving central sensory processing, this study investigated whether tonic transcutaneous cervical VNS (tcVNS) can enhance speech-in-noise intelligibility.</p><p><strong>Materials and methods: </strong>Two cohorts of older human adults (aged 60-84 years) participated in a placebo-controlled, crossover study. Participants completed speech-in-noise assessments using either QuickSIN or AzBio sentences while receiving tonic tcVNS to the neck, or placebo stimulation to the neck-shoulder junction. Speech-in-noise performance was assessed by measuring participants' accuracy in repeating sentences presented at varying signal-to-noise ratios (SNR) within background babble.</p><p><strong>Results: </strong>Tonic tcVNS improved speech-in-noise intelligibility compared with placebo. At the group level, the SNR threshold for 50% speech intelligibility (SNR-50) improved by 0.76 dB in QuickSIN (p = 0.016) and by 0.38 dB in AzBio (p = 0.045). For individual participants, 50% showed improvements that met a minimum clinically important difference (MCID) of 1 dB. Tonic tcVNS evoked progressively greater improvements as SNR increased in QuickSIN (p = 0.021) and AzBio (p = 0.00023), with the largest gains at SNRs >0 dB. In 55% of participants, tcVNS improved intelligibility beyond an MCID benchmark of 4.9% at 5 dB SNR. Although the magnitude of tcVNS-evoked improvements was inversely related to baseline speech-in-noise impairment (p = 0.028), with the individuals having the most impaired speech-in-noise intelligibility showing the largest gains, it did not correlate with hearing loss severity (p = 0.97) or age (p = 0.88).</p><p><strong>Conclusions: </strong>Our findings indicate that tonic tcVNS can evoke immediate and clinically meaningful enhancements in speech-in-noise comprehension. This suggests tcVNS may complement conventional assistive hearing technologies and inform novel therapies for sensory processing disorders.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110109","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}
NeuromodulationPub Date : 2025-05-16DOI: 10.1016/j.neurom.2025.03.078
Ari Rotenberg, Kyrstin Lavelle, Reina Magistro Nadler, Margot Gunning, Zelma H T Kiss, Judy Illes
{"title":"Infringement of Neuromodulation Patents (2000-2024).","authors":"Ari Rotenberg, Kyrstin Lavelle, Reina Magistro Nadler, Margot Gunning, Zelma H T Kiss, Judy Illes","doi":"10.1016/j.neurom.2025.03.078","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.03.078","url":null,"abstract":"<p><strong>Objectives: </strong>There has been a >20-fold increase in neurotechnology patent applications since 2000. These patents are a strong sign of industry growth, but the rights they confer also may be used to hinder innovation. We sought to identify US patent infringement lawsuits involving neuromodulation and assess the implications of litigation for innovation.</p><p><strong>Materials and methods: </strong>Using the legal data base Lexis Advance® Quicklaw®, we conducted a search of US court pleadings filed since 2000 and identified initial complaints. We analyzed the data base for the basis of the complaint, type of neuromodulation, and requests of the court, and determined outcomes on the basis of the court judgments.</p><p><strong>Results: </strong>We found 18 unique patent infringement complaints, 15 of which were filed after 2015. Lawsuits spanned various neuromodulation modalities: spinal cord stimulation (n = 6), transcranial magnetic stimulation (n = 5), sacral nerve stimulation (n = 3), transcutaneous electrical stimulation (n = 2), and vagus nerve stimulation (n = 2). Of the 14 disputes concluded by December 2024, eight caused dismissals; two caused findings of infringement; two caused findings of noninfringement, and two caused findings of patent invalidity that led to dismissals.</p><p><strong>Conclusions: </strong>Inventors in neuromodulation may encounter proprietary barriers when they commercialize their products. The findings here underscore the need for balanced intellectual property policies that simultaneously foster innovation, preserve competition, and protect patient access to technologies.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144086469","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}
NeuromodulationPub Date : 2025-05-16DOI: 10.1016/j.neurom.2025.04.003
Danielle Kohr, Alaa Abd-Elsayed, Michael Kugler
{"title":"Extraforaminal Spinal Nerve Stimulation for Neuropathic Pain: Description of the New Approach, Safety, and Long-term Efficacy.","authors":"Danielle Kohr, Alaa Abd-Elsayed, Michael Kugler","doi":"10.1016/j.neurom.2025.04.003","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.04.003","url":null,"abstract":"<p><strong>Background: </strong>Managing focal neuropathic pain poses significant challenges. Neuromodulation therapies, particularly dorsal root ganglion stimulation (DRG-S), have shown promise in many cases. However, frequent issues with system durability, necessitating revisions, and the complexity of these revisions due to associated difficulties and the limitations in complex cases with difficult access to the epidural space or foramen have prompted practitioners to seek more durable and long-lasting alternatives. Spinal nerve stimulation through an extraforaminal approach offers a promising solution for patients who have exhausted conventional pain therapies or are unsuitable candidates for DRG-S.</p><p><strong>Materials and methods: </strong>This is a single-center, retrospective data analysis in 73 patients with neuropathic pain who underwent spinal nerve stimulation (SNS) using our facility's novel extraforaminal approach from January 2019 to December 2024. The collected data included patient-reported outcomes. We also reviewed any adverse events, complications, or procedure-related issues.</p><p><strong>Results: </strong>Initially, extraforaminal SNS was primarily considered for patients with a history of failed DRG-S. Since 2021, however, this approach has become the primary treatment for focal neuropathic pain at our institution. Of the 73 patients trialed, 75% achieved >50% pain relief, causing permanent implantation in 53 patients. Patient satisfaction remained high, with 38 of 42 patients currently implanted reporting satisfaction in a 2024 follow-up survey. Remarkably, >80% of patients implanted in 2019 and 2020 reported sustained satisfaction five and four years after implantation, respectively. No intraoperative complications or serious adverse events were documented during the trial or after implantation, surgical revisions, or explantation.</p><p><strong>Conclusion: </strong>The extraforaminal SNS approach has shown safety and durability as a treatment for patients with refractory neuropathic pain. With long-term patient satisfaction and a favorable safety profile, it offers a promising alternative to traditional neuromodulation techniques, particularly in complex cases in which DRG-S may be challenging or contraindicated.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144079275","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}
NeuromodulationPub Date : 2025-05-16DOI: 10.1016/j.neurom.2025.03.075
Trish Elliott, Manlin Shao, Derek D George, Lisa Goudman, Deborah R Morris, Julie G Pilitsis
{"title":"Spinal Cord Stimulation Guidelines and Consensus Statements: Systematic Review and Appraisal of Guidelines for Research and Evaluation II Assessment.","authors":"Trish Elliott, Manlin Shao, Derek D George, Lisa Goudman, Deborah R Morris, Julie G Pilitsis","doi":"10.1016/j.neurom.2025.03.075","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.03.075","url":null,"abstract":"<p><strong>Introduction: </strong>Multiple guidelines and consensus statements have been established for spinal cord stimulation (SCS) for pain, including patient selection, indications, techniques of stimulation, and details of the procedure. Here, we sought to critically evaluate guidelines and consensus statements to provide insight into existing gaps in the SCS literature to help guide future endeavors.</p><p><strong>Materials and methods: </strong>We performed a comprehensive and systematic literature search of PubMed, Web of Science, and Scopus on SCS guidelines and consensus statements for pain from 2000 to September 2024 using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The extracted variables included patient selection, efficacy of therapy, pre- and postoperative care, techniques, holding certain medications, complication and infection avoidance and management, and indications. Guidelines and consensus statements were systematically evaluated using the Appraisal of Guidelines for Research and Evaluation II (AGREE-II) tool.</p><p><strong>Results: </strong>The literature search yielded 102 articles. Title, abstract, and full-text analysis determined that 19 articles addressed guidelines and consensus statements relevant to SCS therapy from 2014 to 2024. The 19 articles were systematically analyzed and independently scored by two authors using the AGREE-II instrument. The average global quality score was 5.6 of 7. Current SCS guidelines and consensus statements strongly emphasize evidence-based practice, patient selection, and perioperative management. Weaknesses and gaps include the lack of long-term data on SCS with new waveforms, recommendations on emerging indications, psychologic evaluations, and holistic outcomes.</p><p><strong>Conclusion: </strong>Multiple guidelines and consensus statements attest to the field's commitment to high-quality, evidence-based practice and patient care. However, limitations and gaps remain. Updates on current guidelines should focus on long-term results, holistic assessment and outcomes, and new indications.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144086480","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":"Triple Transcranial Static Magnetic Field Stimulation System (\"SHIN jiba\") Modulates the Neural Activity of the Lumbar Spinal Cord: A Cross-over and Single-Blind Study in Healthy Subjects.","authors":"Haruki Hoshi, Sumiya Shibata, Tatsuya Mima, Hideaki Onishi","doi":"10.1016/j.neurom.2025.04.006","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.04.006","url":null,"abstract":"<p><strong>Objectives: </strong>The triple transcranial static magnetic field stimulation (tSMS) system (SHIN jiba), a new form of tSMS, can generate a stronger magnetic field that reaches deeper regions than the conventional tSMS method. Although SHIN jiba suppresses the neural activity of the brain, the neuromodulatory effects on the spinal cord remain unclear. The aim of this study was to investigate the effects of SHIN jiba on the activity of spinal cord circuits and the ascending neural pathways in the lumbar spinal cord by measuring H-reflex and somatosensory evoked potentials (SEPs).</p><p><strong>Materials and methods: </strong>This study comprised two experiments involving 19 healthy subjects and an additional experiment involving 15 healthy subjects. All experiments were cross-over and single-blind studies. In all experiments, SHIN jiba or sham stimulation was applied over the lumbar region (between the 11th and 12th thoracic vertebrae) for 20 minutes. In experiment 1, H-reflex after the electrical stimulation of the right tibial nerve was recorded before, immediately after, and 15 minutes after the intervention. In experiment 2, SEPs after the electrical stimulation of the right posterior tibial nerve were recorded at the same point as experiment 1.</p><p><strong>Results: </strong>The H-reflex amplitude was significantly suppressed immediately after SHIN jiba stimulation for 20 minutes. In contrast, the SEP amplitudes did not change before and after SHIN jiba stimulation.</p><p><strong>Conclusions: </strong>These findings suggest that SHIN jiba has different effects on the activity of spinal cord circuits and the ascending neural pathways in the lumbar spinal cord. SHIN jiba can be a new tool for modulating the neural activity of the spinal cord.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078225","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}