Neuromodulation最新文献

{"title":"Auricular Allodynia is Associated With Worse Outcomes in Children With Functional Abdominal Pain Disorders Using Neurostimulation","authors":"Neha R. Santucci MD, MBBS ,&nbsp;Umber Waheed MD ,&nbsp;Jesse Li BS ,&nbsp;Sherief Mansi MD ,&nbsp;Kahleb Graham MD ,&nbsp;Jennifer Hardy MSc ,&nbsp;Megan M. Miller PhD ,&nbsp;Rashmi Sahay MD, MS ,&nbsp;Khalil El-Chammas MD","doi":"10.1016/j.neurom.2025.02.011","DOIUrl":"10.1016/j.neurom.2025.02.011","url":null,"abstract":"<div><h3>Background and Aims</h3><div>Percutaneous electrical nerve field stimulation (PENFS) is a minimally invasive, nonpharmacologic approach to treat children with functional abdominal pain disorders (FAPD). Allodynia refers to pain from a stimulus that does not usually provoke pain. We aimed to characterize auricular allodynia during PENFS and associate it with outcomes.</div></div><div><h3>Materials and Methods</h3><div>We conducted a retrospective cohort study reviewing charts of patients who underwent PENFS for an FAPD. We included demographic data, medical history, and validated questionnaire responses. Allodynia was noted through physician notes of localized ear pain, soreness, or tenderness. Baseline clinical scores and PENFS outcomes were compared in patients with and without allodynia.</div></div><div><h3>Results</h3><div>Of 219 patients with FAPD (mean age 16.2 ± 2.7 years), 79% were female, and 87% were Caucasian; 28% of patients experienced allodynia with no significant demographic differences. The most common gastrointestinal symptoms were abdominal pain (100%) and nausea (70%), and the most common FAPD diagnoses included irritable bowel syndrome (58%) and functional dyspepsia (54%). Of the 93 total visits with allodynia, 44% of the visits had patients report allodynia once and 34% twice. Common interventions included placing &lt;four of the usual leads (19%) and early device removal (10%). Patients with allodynia had significantly greater Abdominal Pain Index, pain catastrophizing, Functional Disability Inventory, and insomnia scores (<em>p</em> &lt; 0.05) at treatment completion than did those without allodynia.</div></div><div><h3>Conclusion</h3><div>Allodynia in patients with FAPD who underwent PENFS had worse clinical outcomes. Excitation thresholds of rapidly conducting Aβ fibers in the ear are lower than those of nociceptive slowly conducting Aδ and C fibers. Patients with allodynia may require adjustment of nerve fiber stimulation to improve outcomes.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 5","pages":"Pages 840-846"},"PeriodicalIF":3.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144037620","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":"Ultra-High Frequency Spinal Nerve Neuromodulation for Improving Bladder Continence: Implications for Overactive Bladder Management","authors":"Bor-Shing Lin PhD ,&nbsp;Nurida Khasanah MD ,&nbsp;Chun-Ying Cai BS ,&nbsp;Chun-Wei Wu PhD ,&nbsp;Kuo-Hsiang Lu MS ,&nbsp;Wei-Tso Lin PhD ,&nbsp;Chih-Wei Peng PhD","doi":"10.1016/j.neurom.2024.09.476","DOIUrl":"10.1016/j.neurom.2024.09.476","url":null,"abstract":"<div><h3>Objective</h3><div>Ultrahigh frequencies (UHF) have been shown to selectively suppress the sensory pathway with a rapid onset and prolonged effect compared with low frequencies. Few studies have explored the feasibility of UHF electrical stimulation in treating overactive bladder. This study aimed to investigate whether bladder overactivity could be inhibited by UHF stimulation at the L6 nerve root.</div></div><div><h3>Materials and Methods</h3><div>Female Sprague-Dawley rats (<em>n</em> = 12) were divided into two groups: sham and UHF groups. Bladder overactivity was induced by continuous intravesical infusion of 0.5% acetic acid (AA). UHF L6 nerve root stimulation (500 kHz, 20 mA for 5 minutes) was applied to the rats in the UHF group. To investigate the effects of the treatment, intravesical pressure was recorded by cystometrography during continuous transvesical infusion, with volume threshold (VT) and intercontraction interval (ICI) used to conduct the investigation.</div></div><div><h3>Results</h3><div>Bladder overactivity was successfully developed in all rats with a significant decrease of median VT and ICI to 83.7% and 86.4%, respectively. UHF stimulation of the L6 nerve root was able to counteract the AA effect by significantly increasing median VT and ICI to 220% and 36.1%, respectively; these effects persisted for ≥two hours. There was a significant difference in the effects of UHF electrical stimulation between the sham and UHF groups (<em>p</em> &lt; 0.05).</div></div><div><h3>Conclusion</h3><div>This preliminary study provides evidence for UHF stimulation of the L6 spinal nerve root, analogous to the sacral nerve root in humans, as a potential alternative neuromodulation technique to suppress bladder overactivity.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 5","pages":"Pages 796-802"},"PeriodicalIF":3.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142584036","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":"Frequency-Specific Effects of Noninvasive Median Nerve Stimulation on Gastric Slow Wave Activity in Humans","authors":"Elliot Thomas Hendry BSc ,&nbsp;Joseph Gonzales Balfe BSc ,&nbsp;Peng Du PhD ,&nbsp;Yusuf Ozgur Cakmak MD, PhD","doi":"10.1016/j.neurom.2023.12.005","DOIUrl":"10.1016/j.neurom.2023.12.005","url":null,"abstract":"<div><h3>Objectives</h3><div>The present study explored the effects of different frequencies of noninvasive median nerve stimulation (nMNS) on two autonomic responses: gastric slow waves under water-loading condition and heart rate variability (HRV). To the best of our knowledge, this is the first study to document the effects of different frequencies of nMNS on gastric slow waves (GSW) in humans under 5-minute water-loading condition.</div></div><div><h3>Materials and Methods</h3><div>Twenty healthy adult participants were fitted with a noninvasive body-surface gastric mapping, electrocardiogram (ECG), and a transcutaneous electrical nerve stimulation device and administered with four different nMNS frequencies (placebo-0 Hz, 40 Hz, 120 Hz, and 200 Hz) on four separate counterbalanced days. After the baseline and stimulation periods, a 5-minute water-load test was applied, and a post–water-load period also is recorded for ECG and GSW activity. Time-domain HRV parameters are analyzed with repeated-measures one-way analysis of variance (ANOVA) and a post hoc Tukey multiple comparison test. Parameters that failed normality tests underwent a Freidman test with a post hoc Dunn multiple comparison test. GSW data are analyzed with repeated-measures mixed-effects ANOVA.</div></div><div><h3>Results</h3><div>In empty stomach (baseline vs stimulation), only the 40-Hz frequency statistically significantly (<em>p</em> = 0.0129) increased GSW amplitude in comparison with its own baseline. In full (distended) stomach, 40-Hz and 200-Hz stimulations showed a statistically significant difference (post hoc multiple comparison adjusted, <em>p</em> = 0.0016 and <em>p</em> = 0.0183, respectively) in the Gastric Rhythm Index in comparison with the change obtained by placebo stimulation (baseline vs poststimulation periods); 120-Hz nMNS showed a statistically significant difference (<em>p</em> = 0.0300) in the stress index in comparison with the decrease observed in the placebo group. However, 120-Hz nMNS did not induce a statistically significant change in gastric electrical activity compared to placebo stimulation. The nMNS did not follow the linear “dose-response” relationship between nMNS frequency and gastric/HRV parameters.</div></div><div><h3>Conclusions</h3><div>The 40-Hz and 200-Hz nMNS frequencies showed the most promising results in response to gastric distension, in addition to 40 Hz for an empty stomach. Further research is essential to explore the potential therapeutic effects of these frequencies on gastric diseases such as gastroparesis, gastroesophageal reflux disease, and functional dyspepsia that can be used in wrist wearables.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 5","pages":"Pages 775-786"},"PeriodicalIF":3.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140094395","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":"Motor Response Matters: Lead Placement and Urologic Efficacy Linked in Sacral Neuromodulation","authors":"Sam Tilborghs MD ,&nbsp;Tim Brits MD ,&nbsp;Sigrid van de Borne MSc ,&nbsp;Donald Vaganée MD ,&nbsp;Stefan de Wachter MD, PhD","doi":"10.1016/j.neurom.2024.08.001","DOIUrl":"10.1016/j.neurom.2024.08.001","url":null,"abstract":"<div><h3>Objectives</h3><div>This study aimed to characterize the pelvic floor muscles (PFM) motor response provoked during sacral neuromodulation (SNM) lead placement, determining its utility in improving therapy delivery.</div></div><div><h3>Materials and Methods</h3><div>A prospective pilot study (January 2018–September 2021) was performed including patients with overactive bladder or nonobstructive urinary retention—a very homogeneous group without any medical history interfering with bladder function—who underwent SNM. An external pulse generator was connected for three weeks. Success was defined as ≥50% improvement.</div><div>PFM electromyography was recorded using a multiple array probe.</div><div>Differences in electrical PFM motor response (peak-to-peak amplitude, area under the curve [AUC] or latency) among different electrical stimulation levels up to 10V (and the clinically relevant intensities up to 3V) and different parts (four sides, three depths) of the pelvic floor were modeled using linear mixed model analysis (LMM).</div></div><div><h3>Results</h3><div>The study population comprised 26 women (overall success 81%). With increasing improvement in voiding diary data, higher peak-to-peak amplitudes and AUC were seen for up to 10V stimulation intensities (LMM: <em>p</em> value 0.0046 and 0.0043, respectively) and up to 3V stimulation intensities (LMM: <em>p</em> value 0.0261 and 0.0416, respectively). Subanalysis of the different parts of the PFM showed all different sides (first corrected <em>p</em> value &lt; 0.0125) and depths (first corrected <em>p</em> value &lt; 0.0167) presented with statistically significant differences in favor of those with higher percentage improvement for the 10V and 3V analyses, with only two exceptions: peak-to-peak amplitude at the posterior layer at the clinically relevant stimulation intensities (LMM: <em>p</em> value: 0.0752) and AUC at the posterior layer for the stimulation intensities on 10V (LMM: <em>p</em> value: 0.0557). No statistically significant differences were found for the overall mean peak-to-peak amplitude and AUC based on dichotomous outcome (responders vs nonresponders).</div></div><div><h3>Conclusions</h3><div>Intraoperative PFM electromyography obtained during lead placement aids in more accurate targeting of the lead to the nerve. To our knowledge, this is the first study to correlate tined lead placement based on electrodiagnostic testing and outcome in SNM. It has been proved to be a reliable measurement tool, serving as a physiological biomarker of treatment response during the test phase. A strong motor response can make the surgeon confident that the correct position of the lead has been established for maximal benefit.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 5","pages":"Pages 865-872"},"PeriodicalIF":3.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142470837","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":"Symptom Assessment of Candidates for Sacral Neuromodulation Therapy With Urologic and Colorectal Conditions: Time for a Holistic Approach? Results and Findings From a Prospective Single-Center Study","authors":"Lynn Ghijselings MD ,&nbsp;Irina Verbakel MD ,&nbsp;George Bou Kheir MD ,&nbsp;Dirk Van de Putte MD ,&nbsp;François Hervé MD, PhD ,&nbsp;An-Sofie Goessaert MD, PhD ,&nbsp;Kim Pauwaert MD ,&nbsp;Dimitri Beeckman PhD ,&nbsp;Melissa Ooms MD ,&nbsp;Karel Everaert MD, PhD","doi":"10.1016/j.neurom.2024.04.009","DOIUrl":"10.1016/j.neurom.2024.04.009","url":null,"abstract":"<div><h3>Objectives</h3><div>Sacral neuromodulation<span> (SNM) has evolved as a therapeutic intervention for various pelvic floor dysfunctions. However, the traditional approach primarily assesses discipline-specific symptoms, potentially overlooking holistic symptom improvement. We aimed to investigate whether a more comprehensive evaluation of pelvic floor symptoms enhances the assessment of SNM’s test phase.</span></div></div><div><h3>Material and Methods</h3><div><span><span>A prospective single-center trial (Optimization of Lower Urinary Tract Symptoms study) assessed SNM efficacy from March 2018 to December 2021 in patients from the </span>urology department (UD) and </span>colorectal surgery<span> department (CRD) with a follow-up of 12 months. Objective and subjective outcomes were examined using diaries and patient-reported outcome measures. Statistical analyses were conducted to determine predictive factors for treatment success, expressed by the patient global impression of change. SPSS 29.0 was used.</span></div></div><div><h3>Results</h3><div><span>A total of 85 participants were included, displaying concomitant pelvic floor symptoms. After the first phase, significant improvements on all pelvic floor domains questionnaires were seen for both patients from UD and those from CRD. Although improvements were observed in bladder and bowel diaries, the traditional criteria for success (≥50% improvement in diary variables) did not consistently correlate with the patients' global impression of change. The absolute reductions in bother sum scores from multiple domains were significant predictors for the patients' global impression of change, outperforming discipline-specific assessments. Patients from UD benefit from both a urologic and </span>pelvic pain symptom evaluation, and those from CRD, from both a urologic and bowel symptom evaluation.</div></div><div><h3>Conclusions</h3><div>SNM shows positive effects across various pelvic floor domains, even beyond the primary intended indication of implantation. The rather rigid approach of patient selection of discipline-specific symptoms alone can be questioned. A more comprehensive evaluation encompassing various pelvic floor symptoms with the emphasis on subjective outcome measures could enhance SNM’s efficacy assessment during the test phase.</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 NCT05313984.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 5","pages":"Pages 847-857"},"PeriodicalIF":3.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141284330","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":"Long-term Outcomes of Sacral Nerve Stimulation on the Treatment of Fecal Incontinence: A Systematic Review","authors":"Erica Eggers MD ,&nbsp;Tess Crouss MD ,&nbsp;Jasjit Beausang MD ,&nbsp;Devon Smith DO ,&nbsp;Sean Spector MD ,&nbsp;Benjamin Saracco MLS, MAIT ,&nbsp;Amanda Adams MLS ,&nbsp;Taylor Dickinson MD ,&nbsp;Lioudmila Lipetskaia MD","doi":"10.1016/j.neurom.2024.06.504","DOIUrl":"10.1016/j.neurom.2024.06.504","url":null,"abstract":"<div><h3>Introduction</h3><div>Sacral nerve stimulation (SNS) has now been used as a treatment for fecal incontinence (FI) for &gt;20 years. The aim of this systematic review was to determine the long-term efficacy of SNS on the treatment of FI.</div></div><div><h3>Materials and Methods</h3><div>A comprehensive search of the MEDLINE, Embase, and Cochrane Central data bases was performed to find publications, excluding case reports, reporting outcomes of SNS treatment for FI in adults with ≥36 months of follow-up. Bias was assessed using the Risk of Bias in Non-randomized Studies–of Interventions tool. Data were summarized per reported FI-related outcomes for symptom severity and quality of life.</div></div><div><h3>Results</h3><div>In total, 3326 publications were identified, and 36 studies containing 3770 subjects were included. All studies had a serious risk of bias. Success was variably defined by each publication and ranged from 59.4% to 87.5% for per-protocol analyses and 20.9% to 87.5% for intention-to-treat analyses. All studies reporting bowel diary data, St Mark’s scores, and Cleveland Clinic Incontinence Scores indicated significant improvement with SNS treatment in the long term. Studies that evaluated quality-of-life outcomes also all showed improvements in quality of life as measured by the Fecal Incontinence Quality of Life Scale. The aggregate revision rate was 35.2%, and the explantation rate was 19.7%.</div></div><div><h3>Conclusions</h3><div>Improvements in objective and subjective outcomes at ≥36 months support using SNS for the long-term treatment of FI. Interpretation of these data is limited by a lack of comparative trials and heterogeneity of the included studies.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 5","pages":"Pages 715-726"},"PeriodicalIF":3.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141996216","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 MBBS ,&nbsp;Tan Chen MBBS ,&nbsp;Jinlan Tian MBBS ,&nbsp;Can Zhang MA ,&nbsp;Zijian Zhao MBBS ,&nbsp;Xinru Liu MBBS ,&nbsp;Shuhui Zhang MA ,&nbsp;Yan Chen PhD","doi":"10.1016/j.neurom.2024.12.006","DOIUrl":"10.1016/j.neurom.2024.12.006","url":null,"abstract":"<div><h3>Background and Aims</h3><div>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.</div></div><div><h3>Materials and Methods</h3><div>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 (<em>n</em> = 6, 100 Hz, 1 mA, one hour) or sham EA (<em>n</em> = 6) for 14 days. A normal control group (<em>n</em> = 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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 5","pages":"Pages 812-824"},"PeriodicalIF":3.2,"publicationDate":"2025-07-01","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":"2025 Calendar of Events - June","authors":"","doi":"10.1016/S1094-7159(25)00201-6","DOIUrl":"10.1016/S1094-7159(25)00201-6","url":null,"abstract":"","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 5","pages":"Page 873"},"PeriodicalIF":3.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144523804","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":"A First-In-Human Feasibility Study of a New Implantable Tibial Nerve Stimulator for Overactive Bladder Syndrome","authors":"Parminder S. Sethi MD ,&nbsp;Kenneth M. Peters MD","doi":"10.1016/j.neurom.2025.01.013","DOIUrl":"10.1016/j.neurom.2025.01.013","url":null,"abstract":"<div><h3>Objectives</h3><div>This study aimed to evaluate the preliminary feasibility and safety of a new implantable tibial nerve stimulator device in patients with overactive bladder (OAB).</div></div><div><h3>Materials and Methods</h3><div>Ten patients with OAB in whom conservative treatments had failed participated in the study. All patients received daily stimulation therapy for two weeks and weekly stimulation therapy for 13 weeks, at the lowest electrical output amplitude at which paresthesia or motor response occurred. OAB symptoms (three-day bladder diary), quality-of-life scores (OAB-questionnaire Short Form), and patient global response (GRA) were assessed at each follow-up visit.</div></div><div><h3>Results</h3><div>Among the patients enrolled (mean age 68 years), seven were OAB-wet and three OAB-dry. After 13 weeks of therapy delivery, a reduction in the number of daily voids during waking hours (8.5 ± 2.5 to 6.3 ± 1.9; <em>p</em> = 0.016), incontinence episodes (2.5 ± 1.8 to 0.3 ± 0.5; <em>p &lt;</em> 0.001), and the daily voids associated with urgency (7.6 ± 3.1 to 3.0 ± 3.1; <em>p &lt;</em> 0.001) was reported. Eight of the ten subjects were classified as responders for ≥one OAB component, with one patient reporting worsened symptoms of urgency (+6%). All ten patients reported global improvement in symptoms on the GRA with a median score of 6. Improvements in OAB severity and health-related quality-of-life scores were noted from pre- to posttreatment across participants (<em>p &lt;</em> 0.001). No serious adverse effects were noted.</div></div><div><h3>Conclusion</h3><div>This first-in-human pilot study allowed for capture of preliminary safety and effectiveness information on a new implantable tibial nerve stimulator device in the population of interest to adequately power a larger, pivotal randomized study.</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 NCT04115228.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 5","pages":"Pages 832-839"},"PeriodicalIF":3.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143542557","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 MBBS, MS ,&nbsp;Feng Ye MD, PhD ,&nbsp;Sujuan Zhang MD, PhD ,&nbsp;Yi Liu MD, PhD ,&nbsp;Jiande D.Z. Chen PhD","doi":"10.1016/j.neurom.2024.12.005","DOIUrl":"10.1016/j.neurom.2024.12.005","url":null,"abstract":"<div><h3>Background</h3><div>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).</div></div><div><h3>Materials and Methods</h3><div>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.</div></div><div><h3>Results</h3><div>The study findings were 1) CRD significantly reduced the percentage of NSW from 89.2% ± 1.6% to 64.3% ± 3.5% (<em>p</em> &lt; 0.001), which was mitigated by VNS at 14 Hz (83.5% ± 3.0%, <em>p</em> &lt; 0.001) and 25 Hz (88.4% ± 1.7%, <em>p</em> &lt; 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%, <em>p</em> &lt; 0.01); and 3) CRD delayed gastric emptying, which was restored by 25 Hz VNS.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 5","pages":"Pages 767-774"},"PeriodicalIF":3.2,"publicationDate":"2025-07-01","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}