Neuromodulation最新文献

{"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}

{"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}

{"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}

{"title":"Effect of Vagus Nerve Stimulation on Electroencephalogram Synchronization: A Longitudinal Study Using a Clinical-Research Response Scale.","authors":"Venethia Danthine, Enrique Ignacio Germany Morrison, Lise Cottin, Giulia Liberati, Inci Cakiroglu, Vincent Joris, André Mouraux, Roberto Santalucia, Alexane Fierain, Pascal Vrielynck, Susana Ferrao Santos, Antoine Nonclercq, Riëm El Tahry","doi":"10.1016/j.neurom.2025.03.068","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.03.068","url":null,"abstract":"<p><strong>Objectives: </strong>No reliable biomarkers exist for predicting and assessing vagus nerve stimulation (VNS) response. While VNS induces acute electroencephalography (EEG) desynchronization after implantation, longitudinal evaluations of EEG synchronization changes are lacking. This study constitutes the first prospective investigation evaluating EEG synchronization before and after VNS device implantation and correlating it with the clinical response to VNS.</p><p><strong>Materials and methods: </strong>High-density EEG recordings were obtained from 12 adults with drug-resistant epilepsy before and after VNS device implantation (one, three, and six months). EEG resting state (180 seconds), with eyes open and eyes closed (EC), was recorded in VNS ON and OFF conditions. The global weighted phase lag index (wPLI) was computed as an EEG phase-synchronization measure and correlated with the VNS response using various assessment methods, including binary classification (>50% or <50% seizure frequency reduction), percentage of seizure reduction, and the newly developed Clinical-Research Response Scale (CRRS).</p><p><strong>Results: </strong>We observed a progressive decrease of wPLI in the delta band during the EC VNS OFF condition, which correlated with the VNS response over time, particularly when assessed using the new CRRS compared with other assessment methods. Additionally, a higher preimplant global wPLI predicted a better outcome of VNS, as did an early magnet response.</p><p><strong>Conclusions: </strong>Overall, VNS may positively influence specific brain states, with a time-dependent evolution of EEG synchronization reflecting therapeutic efficacy. Preimplantation EEG synchronization and an early magnet response may predict VNS response. Moreover, the CRRS could constitute a more sensitive method for characterizing VNS response compared with traditional assessment methods.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144021254","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":"Transcutaneous Auricular Vagus Nerve Stimulation in Insomnia: A Systematic Review and Meta-Analysis.","authors":"Helen Michaela de Oliveira, Mariano Gallo Ruelas, Camilo André Viana Diaz, Guilherme Oliveira de Paula, Pablo Ramon Fruett da Costa, Julie G Pilitsis","doi":"10.1016/j.neurom.2025.04.001","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.04.001","url":null,"abstract":"<p><strong>Objectives: </strong>Insomnia is a prevalent condition with significant impacts on quality of life, often accompanied by anxiety and depression. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a noninvasive therapeutic option, but its efficacy and mechanisms remain to be fully elucidated. This systematic review and meta-analysis aimed to evaluate the clinical effectiveness of taVNS on insomnia, as measured by the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI).</p><p><strong>Materials and methods: </strong>We systematically searched PubMed, Embase, and the CENTRAL data bases up to January 2025 for clinical trials comparing taVNS in patients with insomnia. This study followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Statistical analyses were performed using R version 4.3.2. The risk of bias was assessed using the Risk Of Bias In Non-randomized Studies - of Interventions and Risk Of Bias in Randomized Studies tools, and the quality of evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) assessment. The study was registered in the International Prospective Register of Systematic Reviews under protocol CRD42025634016.</p><p><strong>Results: </strong>Of 313 studies screened, six met the inclusion criteria and were included, encompassing a total of 336 patients. The pooled analysis showed statistically significant improvements in sleep quality and insomnia severity, as measured by PSQI (MD = -3.60; 95% CI = -4.98 to -2.22; p < 0.01; GRADE = Low evidence) and ISI (MD = -5.24; 95% CI = -9.02 to -1.46; p < 0.01; GRADE = Very low evidence) scores. Moreover, the studies reported improvements in sleep subscales, including overall sleep quality, latency, duration, and efficiency. Adverse effects were minimal and manageable, highlighting the safety profile of taVNS and supporting its potential as a well-tolerated, noninvasive treatment option for insomnia.</p><p><strong>Conclusion: </strong>taVNS can significantly relieve insomnia, supported by its neural and autonomic pathways modulation. These findings highlight taVNS as a promising, safe, and noninvasive treatment for insomnia, warranting further research to optimize its application and expand its use in broader populations.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144029561","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":"Poor Effectiveness of Occipital Nerve Stimulation in Treating Refractory Neuropathic Facial Pain: A Case Series.","authors":"Sofia Ferrão Malheiro, Nathan Beucler, Aurélie Leplus, Michel Lanteri-Minet, Denys Fontaine","doi":"10.1016/j.neurom.2025.04.002","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.04.002","url":null,"abstract":"<p><strong>Context: </strong>Neuropathic facial pain (NFP) that remains refractory to optimal pharmacologic management imposes a significant burden on patients and a challenge to pain specialists. Recent clinical evidence indicates that peripheral nerve stimulation (PNS) exhibits therapeutic potential in managing occipital and facial neuropathic pain. This study aims to evaluate the effectiveness of occipital nerve stimulation (ONS) specifically in the treatment of NFP.</p><p><strong>Materials and methods: </strong>We conducted a retrospective case series involving prospectively enrolled patients with refractory NFP unresponsive to optimal specific medical therapy and in some instances motor cortex stimulation. These patients were treated under a compassionate use framework for unilateral NFP using ONS. Each patient underwent an initial ONS trial lasting a minimum of two weeks. If they experienced an alleviation of their NFP >40%, they proceeded to definitive implantation one month later.</p><p><strong>Results: </strong>Overall, 13 patients were included in the study, with a mean age of 66 years and a male-to-female ratio of 1.2:1. The average duration from NFP onset to ONS surgery was 9.6 years. During the trial period, only six patients (46%) experienced significant improvement and proceeded to implantation. However, three of these patients (23%) did not report any benefit one month after implantation, motivating hardware removal. In addition, in two patients (15%), the initial improvement did not translate to long-term relief. Ultimately, only one patient (8%) reported sustained long-term improvement in NFP. Notably, this patient had experienced a ten-year benefit from motor cortex stimulation before they underwent ONS.</p><p><strong>Conclusion: </strong>In light of our results, the limited and inconsistent improvements observed in a minority of patients suggest that ONS may not be a reliable surgical treatment option for NFP.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144026231","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":"Exploring Rates of Functional Neurosurgery Procedures in the Hispanic Population: A Single-Institution Analysis From 2017 to 2024.","authors":"Derek D George, Manlin Shao, Jerry M Brown, Marisa DiMarzio, Martin E Weinand, Paul S Larson, Willard S Kasoff, Julie G Pilitsis","doi":"10.1016/j.neurom.2025.03.077","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.03.077","url":null,"abstract":"<p><strong>Introduction: </strong>Racial and ethnic disparities in utilization of functional neurosurgical procedures have been extensively documented. However, few studies have focused on the differences between Hispanic and non-Hispanic White populations in regions with high representation of both groups. Given the large Hispanic population within our hospital's catchment area, we aimed to compare the utilization of functional neurosurgery between the Hispanic and White populations in our practice.</p><p><strong>Materials and methods: </strong>We conducted a retrospective review of patients undergoing functional neurosurgery procedures from 2017 to 2024 at the University of Arizona in Tucson. Rates of epilepsy, pain, and movement disorder procedures were compared by ethnicity, focusing on Hispanic vs non-Hispanic White populations. Correlations with age, American Society of Anesthesiologists class, income, insurance status, distance from the treatment center, and complications were examined.</p><p><strong>Results: </strong>A total of 750 procedures were performed among 702 patients. Deep brain stimulation accounted for 27.73% of procedures, spinal cord stimulation for 35.87%, epilepsy surgery for 22.53%, and intrathecal pump placement for 13.7%. Among the included patients, 43.3% were treated for chronic pain, 22.5% for epilepsy, 18.1% for Parkinson's disease, 4.8% for essential tremor, 2.3% for spasticity, 0.9% for dystonia, and 8.0% for other/unknown diagnoses. Regarding ethnicity, 74.3% of our cohort identified as non-Hispanic White, 18.1% as Hispanic, and 7.6% as other or unknown ethnicity. Hispanic patients were significantly underrepresented relative to Southern Arizona demographics (χ² [1, n = 693] = 280.38, p < 0.0001, ϕ=0.64). This disparity was consistent and significant across all procedure types. Significant differences in five-year median inflation-adjusted household income were observed between Hispanic and White non-Hispanic groups (Welch t-test [n = 693] = 5.79, p < 0.0001, Cohen d = 0.53). Cluster analysis revealed four distinct clusters based on multiple predictors, and multinomial regression identified several significant predictors of undergoing each procedure type.</p><p><strong>Discussion: </strong>Functional procedures are underutilized among Hispanic patients in Southern Arizona, with disparities associated with age, income, and distance from the treatment center.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144026230","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":"Tremor Associated With Klinefelter Syndrome: Report of a Case Treated by Deep Brain Stimulation and Systematic Review of the Literature.","authors":"Baraa Dabboucy, Reza Hazrati, Melanie Langlois, Michel Prudhomme","doi":"10.1016/j.neurom.2025.03.073","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.03.073","url":null,"abstract":"<p><strong>Introduction: </strong>Klinefelter syndrome (KS) is a sex chromosome-related genetic disease that commonly affects male subjects with infertility. Small testes, gynecomastia, infertility, and possible developmental abnormalities are symptoms of this condition. According to recent studies, people with KS also may have other neurologic problems, particularly tremors resembling essential tremors. Our review attempts to explore the features of tremors and their treatment in individuals with KS using case studies and previously published research.</p><p><strong>Materials and methods: </strong>A PubMed/Medline search was conducted according to the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines using the following MeSH terms: (\"Tremor\") AND (\"Klinefelter syndrome\") OR (\"Tremor\") AND (\"associated\") AND (\"Klinefelter syndrome\") OR (\"Tremor\") AND (\"hypogonadism\"). The review included 24 articles.</p><p><strong>Results: </strong>The average age at tremor onset was 15.59 years, and the most prevalent tremor types (31.91% of cases) were a combination of postural and kinetic/intention tremors. Overall, 40% of patients exhibited some improvement; 10% showed significant improvement, and 50% showed no impact when antitremor medications were administered. Testosterone replacement therapy is not a suitable option for this symptom because the effects of testosterone treatment on tremors are inconsistent. In each of the three described cases, tremors were significantly relieved after deep brain stimulation (DBS) surgery of the ventral intermediate nucleus (VIM). We also report a case of a man aged 54 years with KS who was unable to perform his regular tasks owing to severe tremors. His tremor was well managed with bilateral DBS of the thalamic VIM nucleus.</p><p><strong>Conclusion: </strong>Tremors are a potentially disabling associated manifestation of KS. The available literature on the management of tremors in patients with KS is limited. Surgical VIM-DBS has shown promising results in managing medication-refractory tremors in patients with KS, with an acceptable safety profile. Further research is needed to determine the causes of tremors in KS and to optimize treatment.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144019982","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":"Safety and Efficacy of Magnetic Peripheral Nerve Stimulation for Treating Painful Diabetic Neuropathy.","authors":"Lora Brown, Emmanuel Gage, Harold Cordner, Leonardo Kapural, Jason Rosenberg, Marshall Bedder","doi":"10.1016/j.neurom.2025.03.074","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.03.074","url":null,"abstract":"<p><strong>Objectives: </strong>Current treatments for painful diabetic neuropathy (PDN) have variable effectiveness and known side effects. Noninvasive magnetic peripheral nerve stimulation (mPNS) provides effective pain relief without the side effects associated with interventional approaches. This study measured the differences in pain relief, sensory, and quality of life improvements using mPNS and conventional medical management (CMM) compared with sham and CMM in patients with PDN.</p><p><strong>Materials and methods: </strong>A multicenter, randomized clinical trial was conducted from December 2022 to November 2023. Patients were randomized to receive either mPNS and CMM or sham and CMM. Subjects were randomized to treatment groups in a 3:1 ratio to mPNS+CMM or Sham+CMM and observed for 30 days during the double-blinded phase (phase 1). At 30 days, the subjects in the Sham+CMM group could cross over to the mPNS group, initiating phase 2. All patients were followed up for 90 days after the first mPNS treatment. The primary end point was the between-group comparison of the proportion of responders, a subject who experienced ≥50% reduction from baseline in neuropathic pain measured by visual analog scale on day 30. Secondary end points included between-group comparison of percentage change from baseline for pain and numbness scores (days 30/90), responders to mPNS (day 90), and results from other quality-of-life measures (day 90).</p><p><strong>Results: </strong>After 92 subjects were screened, 71 met the study inclusion/exclusion criteria and were treated. Subjects were similar in the groups, except for sex: 24 men (48%) in the mPNS group (n = 50) and 18 (85.7%) in the sham group (n = 21) (p = 0.0096). In the per-protocol analysis set, the mPNS group had a 72.3% responder rate (day 30) compared with 0% for sham (72.3% difference; 95% CI, 54.3-84.8; p < 0.0001), and 57.8% pain reduction from baseline, with 12.1% for sham. At day 90, mPNS had an 81.4% responder rate with 75.7% average pain reduction.</p><p><strong>Conclusions: </strong>The data revealed that mPNS+CMM is superior to Sham+CMM at day 30 when used for treating pain from PDN. mPNS should be considered earlier in the treatment algorithm for PDN.</p><p><strong>Clinical trial registration: </strong>The Clinicaltrials.gov registration number for the study is NCT05620225 (https://clinicaltrials.gov/study/NCT05620225). The study was first posted on November 9, 2022, and the first patient was enrolled on December 15, 2022.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144006138","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}