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Adverse Events Associated With Peripheral Nerve Stimulation: An Analysis of the MAUDE Data base and Implications for Pain and Spine Clinicians. 与外周神经刺激相关的不良事件:MAUDE 数据库分析及对疼痛和脊柱临床医生的启示》。
IF 3.2 3区 医学
Neuromodulation Pub Date : 2025-04-03 DOI: 10.1016/j.neurom.2025.02.002
Amanda N Cooper, Hasan Sen, Napatpaphan Kanjanapanang, Kristen Saad, Garret Wahl, Matthew Essman, Alexandra E Fogarty, Taylor Burnham, Aaron M Conger, Zachary L McCormick, Allison Glinka Przybysz, Chase Young
{"title":"Adverse Events Associated With Peripheral Nerve Stimulation: An Analysis of the MAUDE Data base and Implications for Pain and Spine Clinicians.","authors":"Amanda N Cooper, Hasan Sen, Napatpaphan Kanjanapanang, Kristen Saad, Garret Wahl, Matthew Essman, Alexandra E Fogarty, Taylor Burnham, Aaron M Conger, Zachary L McCormick, Allison Glinka Przybysz, Chase Young","doi":"10.1016/j.neurom.2025.02.002","DOIUrl":"https://doi.org/10.1016/j.neurom.2025.02.002","url":null,"abstract":"<p><strong>Of background data: </strong>The use of peripheral nerve stimulation (PNS) devices within pain and spine-related care has increased significantly in recent years. The United States Food and Drug Administration (FDA)-approved indications for PNS have expanded rapidly with technologic advances and randomized controlled trials demonstrating its efficacy. Analysis of real-world data regarding the complications associated with PNS can help inform clinical decision-making and patient counseling as the use of this neuromodulation therapy continues to evolve.</p><p><strong>Objectives: </strong>This study aimed to categorize adverse events (AEs) described in medical device reports (MDRs) within the FDA Manufacturer and User Facility Device Experience (MAUDE) data base related to the use of PNS for pain and spinal indications.</p><p><strong>Materials and methods: </strong>A comprehensive search within the MAUDE data base was conducted to identify AEs related to FDA-approved PNS devices reported between January 1, 2023 and December 31, 2023, specifically to capture AEs related to current PNS technology in clinical use. AEs were manually categorized according to event descriptions.</p><p><strong>Results: </strong>We identified 594 unique MDRs associated with the five PNS devices currently approved by the FDA for use in the spine. While most MDRs (77.1%) did not specify lead location, spinal lead placements were implicated in 9.1% of cases, and appendicular lead placement accounted for 13.8%. Infection (22.7%), migration (14.7%), and skin erosion (9.4%) were the most common AEs reported. Most entries were categorized as device-related (40.1%) or procedural AEs (32.7%), and the remainder as patient complaints (17.3%), serious AEs (1.0%), and \"other\" complications (6.1%). Most complications were managed with explantations (43.8%) rather than revisions (29.5%).</p><p><strong>Discussion/conclusion: </strong>New technologies and their applications must be regularly evaluated for safety and effectiveness. Our analysis of the MAUDE data base revealed that infection, lead migration, and skin erosion were the most commonly reported AEs associated with the use of PNS technology during 2023. Most AEs were deemed to be device- or procedure-related.</p>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772944","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}
引用次数: 0
A Novel Closed-Loop Electrical Brain Stimulation Device Featuring Wireless Low-Energy Ultrasound Power and Communication 具有无线低能量超声波功率和通信功能的新型闭环脑电刺激装置
IF 3.2 3区 医学
Neuromodulation Pub Date : 2025-04-01 DOI: 10.1016/j.neurom.2024.02.008
Joseph S. Neimat MD, MS , Robert W. Bina MD, MS , Steven C. Koenig PhD , Emrecan Demirors PhD , Raffaele Guida PhD , Ryan Burke PhD , Tommaso Melodia PhD , Jorge Jimenez PhD
{"title":"A Novel Closed-Loop Electrical Brain Stimulation Device Featuring Wireless Low-Energy Ultrasound Power and Communication","authors":"Joseph S. Neimat MD, MS ,&nbsp;Robert W. Bina MD, MS ,&nbsp;Steven C. Koenig PhD ,&nbsp;Emrecan Demirors PhD ,&nbsp;Raffaele Guida PhD ,&nbsp;Ryan Burke PhD ,&nbsp;Tommaso Melodia PhD ,&nbsp;Jorge Jimenez PhD","doi":"10.1016/j.neurom.2024.02.008","DOIUrl":"10.1016/j.neurom.2024.02.008","url":null,"abstract":"<div><h3>Objectives</h3><div>This study aimed to indicate the feasibility of a prototype electrical neuromodulation system using a closed-loop energy-efficient ultrasound-based mechanism for communication, data transmission, and recharging.</div></div><div><h3>Materials and Methods</h3><div><span>Closed-loop deep brain stimulation (DBS) prototypes were designed and fabricated with ultrasonic wideband (UsWB) communication technology and miniaturized custom electronics. Two devices were implanted short term in anesthetized Göttingen minipigs (</span><em>N</em><span> = 2). Targeting was performed using preoperative magnetic resonance imaging, and locations were confirmed postoperatively by computerized tomography<span>. DBS systems were tested over a wide range of stimulation settings to mimic minimal, typical, and/or aggressive clinical settings, and evaluated for their ability to transmit data through scalp tissue and to recharge the DBS system using UsWB.</span></span></div></div><div><h3>Results</h3><div>Stimulation, communication, reprogramming, and recharging protocols were successfully achieved in both subjects for amplitude (1V–6V), frequency (50–250 Hz), and pulse width (60–200 μs) settings and maintained for ≥six hours. The precision of pulse settings was verified with &lt;5% error. Communication rates of 64 kbit/s with an error rate of 0.05% were shown, with no meaningful throughput degradation observed. Time to recharge to 80% capacity was &lt;9 minutes. Two DBS systems also were implanted in the second test animal, and independent bilateral stimulation was successfully shown.</div></div><div><h3>Conclusions</h3><div><span><span>The system performed at clinically relevant implant depths and settings. Independent bilateral stimulation for the duration of the study with a 4F energy storage and full rapid recharge were achieved. Continuous function extrapolates to six days of continuous stimulation in future design iterations implementing </span>application specific integrated circuit </span>level efficiency<span> and 15F storage capacitance. UsWB increases energy efficiency, reducing storage requirements and thereby enabling device miniaturization. The device can enable intelligent closed-loop stimulation, remote system monitoring, and optimization and can serve as a power/data gateway to interconnect the intrabody network with the Internet of Medical Things.</span></div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 3","pages":"Pages 455-463"},"PeriodicalIF":3.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141180266","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}
引用次数: 0
Systematic Review of Experimental Deep Brain Stimulation in Rodent Models of Epilepsy 实验性脑深部电刺激对啮齿动物癫痫模型的系统评价。
IF 3.2 3区 医学
Neuromodulation Pub Date : 2025-04-01 DOI: 10.1016/j.neurom.2024.11.001
Rafi Matin HBSc , Kristina Zhang BMSc , George M. Ibrahim MD, PhD , Flavia Venetucci Gouveia PhD
{"title":"Systematic Review of Experimental Deep Brain Stimulation in Rodent Models of Epilepsy","authors":"Rafi Matin HBSc ,&nbsp;Kristina Zhang BMSc ,&nbsp;George M. Ibrahim MD, PhD ,&nbsp;Flavia Venetucci Gouveia PhD","doi":"10.1016/j.neurom.2024.11.001","DOIUrl":"10.1016/j.neurom.2024.11.001","url":null,"abstract":"<div><h3>Objectives</h3><div>Deep brain stimulation (DBS) is an established neuromodulatory technique for treating drug-resistant epilepsy. Despite its widespread use in carefully selected patients, the mechanisms underlying the antiseizure effects of DBS remain unclear. Herein, we provide a detailed overview of the current literature pertaining to experimental DBS in rodent models of epilepsy and identify relevant trends in this field.</div></div><div><h3>Materials and Methods</h3><div>A systematic review was conducted using the PubMed MEDLINE database, following PRISMA guidelines. Data extraction focused on study characteristics, including stimulation protocol, seizure and behavioral outcomes, and reported mechanisms of action.</div></div><div><h3>Results</h3><div>Of the 1788 resultant articles, 164 were included. The number of published articles has grown exponentially in recent decades. Most studies used chemically or electrically induced models of epilepsy. DBS targeting the anterior nucleus of the thalamus, hippocampal formation, or amygdala was most extensively studied. Effective stimulation parameters were identified, and novel stimulation designs were explored, such as closed-loop and unstructured stimulation approaches. Common mechanisms included synaptic modulation through the depression of excitatory neurotransmission and inhibitory release of GABA. At the network level, antiseizure effects were associated with the desynchronization of neural networks, characterized by decreased low-frequency oscillations.</div></div><div><h3>Conclusions</h3><div>Rodent models have significantly advanced the understanding of disease pathophysiology and the development of novel therapies. However, fundamental questions remain regarding DBS mechanisms, optimal targets, and parameters. Further research is necessary to improve DBS therapy and tailor treatment to individual patient circumstances.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 3","pages":"Pages 401-413"},"PeriodicalIF":3.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786257","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}
引用次数: 0
Delay- and Pressure-Dependent Neuromodulatory Effects of Transcranial Ultrasound Stimulation 经颅超声刺激的延迟和压力依赖性神经调节作用。
IF 3.2 3区 医学
Neuromodulation Pub Date : 2025-04-01 DOI: 10.1016/j.neurom.2025.01.004
Cyril Atkinson-Clement PhD , Mohammad Alkhawashki MSc , Marilyn Gatica PhD , Stefanos Alexandros Kontogouris MSc , Marcus Kaiser PhD
{"title":"Delay- and Pressure-Dependent Neuromodulatory Effects of Transcranial Ultrasound Stimulation","authors":"Cyril Atkinson-Clement PhD ,&nbsp;Mohammad Alkhawashki MSc ,&nbsp;Marilyn Gatica PhD ,&nbsp;Stefanos Alexandros Kontogouris MSc ,&nbsp;Marcus Kaiser PhD","doi":"10.1016/j.neurom.2025.01.004","DOIUrl":"10.1016/j.neurom.2025.01.004","url":null,"abstract":"<div><h3>Objective</h3><div>Despite the growing interest in transcranial focused ultrasound stimulation (TUS), our understanding of its underlying mechanisms remains limited. In this study, we aimed to investigate the effects of TUS on several functional magnetic resonance imaging metrics by considering their latency, duration, and relationship with applied acoustic pressure.</div></div><div><h3>Materials and methods</h3><div>We recruited 22 healthy volunteers and used a pre- vs post-TUS protocol. Half of the volunteers were stimulated in the right inferior frontal cortex and the other half in the right thalamus. The fractional amplitudes of low-frequency fluctuations, regional homogeneity, degree centrality, local functional connectivity density, and eigenvector centrality were considered. These metrics were compared before TUS and at three different time points in the first hour after TUS.</div></div><div><h3>Results</h3><div>Our results showed that 1) TUS primarily alters functional connectivity metrics at both the local and global levels; 2) stronger alterations are observed when the delay after TUS increases and 3) when the applied acoustic pressure is close to the maximum.</div></div><div><h3>Conclusion</h3><div>These results suggest that some consequences of TUS might not be immediate, inviting us to revise the premise that TUS consequences are immediate and will progressively disappear.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 3","pages":"Pages 444-454"},"PeriodicalIF":3.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143365046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Timing Matters: Preconditioning Effects of Cathodal Transcranial Direct Current Stimulation on Intermittent Theta-Burst Stimulation-Induced Neuroplasticity in the Primary Motor Cortex 时间问题:阴极经颅直流电刺激对间歇性θ -爆发刺激诱导的初级运动皮层神经可塑性的预处理效应。
IF 3.2 3区 医学
Neuromodulation Pub Date : 2025-04-01 DOI: 10.1016/j.neurom.2025.01.006
Wenjun Dai MSc , Yishu Zhang BSc , Yihui Cheng MSc , Manyu Dong BSc , Yilun Qian BSc , Xinyue Wang BSc , Chuan Guo MSc , Hanjun Liu PhD , Ying Shen PhD
{"title":"Timing Matters: Preconditioning Effects of Cathodal Transcranial Direct Current Stimulation on Intermittent Theta-Burst Stimulation-Induced Neuroplasticity in the Primary Motor Cortex","authors":"Wenjun Dai MSc ,&nbsp;Yishu Zhang BSc ,&nbsp;Yihui Cheng MSc ,&nbsp;Manyu Dong BSc ,&nbsp;Yilun Qian BSc ,&nbsp;Xinyue Wang BSc ,&nbsp;Chuan Guo MSc ,&nbsp;Hanjun Liu PhD ,&nbsp;Ying Shen PhD","doi":"10.1016/j.neurom.2025.01.006","DOIUrl":"10.1016/j.neurom.2025.01.006","url":null,"abstract":"<div><h3>Background</h3><div>Recent advances have highlighted the interplay between intermittent theta-burst stimulation (iTBS) and transcranial direct current stimulation (tDCS) in neuroplasticity modulation. However, the synergistic potential of these modalities in optimizing plasticity, particularly with cathodal tDCS preconditioning before iTBS, remains poorly understood.</div></div><div><h3>Objective</h3><div>This study examined the effects of cathodal high-definition tDCS (HD-tDCS) preconditioning on iTBS-induced neuroplasticity in the primary motor cortex at different timing intervals.</div></div><div><h3>Materials and Methods</h3><div>Twenty healthy participants underwent four stimulation sessions in a randomized cross-over design, receiving iTBS either immediately or at 10-minute and 30-minute intervals after cathodal HD-tDCS preconditioning, in addition to a control session with iTBS immediately after sham HD-tDCS. Motor evoked potentials (MEPs) were measured at baseline and 5, 10, 15, and 30 minutes after iTBS to assess changes in neuroplasticity. Each session was separated by ≥one week to prevent carry-over effects.</div></div><div><h3>Results</h3><div>Compared with sham sessions, immediate cathodal HD-tDCS preconditioning significantly enhanced MEPs across all measured intervals after iTBS, with sustained neuroplasticity persisting for up to 30 minutes. Immediate preconditioning produced significant MEP enhancements at 5 and 10 minutes when compared with the 30-minute delayed condition.</div></div><div><h3>Conclusions</h3><div>The effectiveness of cathodal tDCS preconditioning in enhancing iTBS-induced neuroplasticity decreased with increasing intervals between tDCS and iTBS application. These findings highlight the essential role of precise timing in tDCS preconditioning for maximizing the neuroplastic effects of iTBS and offer valuable insights for optimizing neurorehabilitation protocols.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 3","pages":"Pages 520-531"},"PeriodicalIF":3.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449686","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}
引用次数: 0
2025 Calendar of Events - April 2025年活动日历- 4月
IF 3.2 3区 医学
Neuromodulation Pub Date : 2025-04-01 DOI: 10.1016/S1094-7159(25)00040-6
{"title":"2025 Calendar of Events - April","authors":"","doi":"10.1016/S1094-7159(25)00040-6","DOIUrl":"10.1016/S1094-7159(25)00040-6","url":null,"abstract":"","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 3","pages":"Page 549"},"PeriodicalIF":3.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143747763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Modulation of Local Field Potentials in the Deep Brain of Minipigs Through Transcranial Temporal Interference Stimulation 通过经颅颞叶干扰刺激调节迷你猪大脑深部的局部场电位
IF 3.2 3区 医学
Neuromodulation Pub Date : 2025-04-01 DOI: 10.1016/j.neurom.2024.10.002
Hsiao-Chun Lin PhD , Yi-Hui Wu PhD , Ming-Dou Ker PhD
{"title":"Modulation of Local Field Potentials in the Deep Brain of Minipigs Through Transcranial Temporal Interference Stimulation","authors":"Hsiao-Chun Lin PhD ,&nbsp;Yi-Hui Wu PhD ,&nbsp;Ming-Dou Ker PhD","doi":"10.1016/j.neurom.2024.10.002","DOIUrl":"10.1016/j.neurom.2024.10.002","url":null,"abstract":"<div><h3>Objectives</h3><div>Transcranial temporal interference stimulation (tTIS) is a novel, noninvasive neuromodulation technique to modulate deep brain neural activity. Despite its potential, direct electrophysiological evidence of tTIS effects remains limited. This study investigates the impact of tTIS on local field potentials (LFPs) in the deep brain using minipigs implanted with deep brain electrodes.</div></div><div><h3>Materials and Methods</h3><div>Three minipigs were implanted with electrodes in the subthalamic nucleus, and tTIS was applied using patch electrode pairs positioned on both sides of the scalp. Stimulation was delivered in sinewave voltage mode with intensities ≤2V. We evaluated the stimulus-response relationship, effects of different carrier frequencies, the range of entrained envelope oscillations, and changes resulting from adjusting the left-right stimulation intensity ratio.</div></div><div><h3>Results</h3><div>The results indicated that tTIS modulates deep-brain LFPs in an intensity-dependent manner. Carrier frequencies of 1 or 2 kHz were most effective in influencing LFP. Envelope oscillations &lt;200 Hz were effectively entrained into deep-brain LFPs. Adjustments to the stimulation intensity ratio between the left and right sides yielded inconsistent responses, with right-sided stimulation playing a dominant role.</div></div><div><h3>Conclusion</h3><div>These findings indicate that tTIS can regulate LFP changes in the deep brain, highlighting its potential as a promising tool for future noninvasive neuromodulation applications.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 3","pages":"Pages 434-443"},"PeriodicalIF":3.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142624302","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}
引用次数: 0
Clinically Implemented Sensing-Based Initial Programming of Deep Brain Stimulation for Parkinson’s Disease: A Retrospective Study 临床实施基于感觉的帕金森病深部脑刺激初始规划:一项回顾性研究。
IF 3.2 3区 医学
Neuromodulation Pub Date : 2025-04-01 DOI: 10.1016/j.neurom.2024.11.002
Bart E.K.S. Swinnen MD, PhD , Andrea Fuentes MD , Monica M. Volz FNP, MSN , Susan Heath , Philip A. Starr MD, PhD , Simon J. Little MD, PhD , Jill L. Ostrem MD
{"title":"Clinically Implemented Sensing-Based Initial Programming of Deep Brain Stimulation for Parkinson’s Disease: A Retrospective Study","authors":"Bart E.K.S. Swinnen MD, PhD ,&nbsp;Andrea Fuentes MD ,&nbsp;Monica M. Volz FNP, MSN ,&nbsp;Susan Heath ,&nbsp;Philip A. Starr MD, PhD ,&nbsp;Simon J. Little MD, PhD ,&nbsp;Jill L. Ostrem MD","doi":"10.1016/j.neurom.2024.11.002","DOIUrl":"10.1016/j.neurom.2024.11.002","url":null,"abstract":"<div><h3>Objectives</h3><div>Initial deep brain stimulation (DBS) programming using a monopolar review is time-consuming, subjective, and burdensome. Incorporating neurophysiology has the potential to expedite, objectify, and automatize initial DBS programming. We aimed to assess the feasibility and performance of clinically implemented sensing-based initial DBS programming for Parkinson’s disease (PD).</div></div><div><h3>Materials and Methods</h3><div>We conducted a single-center retrospective study in 15 patients with PD (25 hemispheres) implanted with a sensing-enabled neurostimulator in whom initial subthalamic nucleus/globus pallidus pars interna DBS programming was guided by beta power in real-time local field potential recordings, instead of a monopolar review.</div></div><div><h3>Results</h3><div>The initial sensing-based programming visit lasted on average 42.2 minutes (SD 18) per hemisphere. During the DBS optimization phase, a conventional monopolar clinical review was not required in any patients. The initial stimulation contact level remained the same at the final follow-up visit in all hemispheres except three. The final amplitude was on average 0.8 mA (SD 0.9) higher than initially set after the original sensing-based programming visit. One year after surgery, off-medication International Parkinson and Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) III total score, tremor subscore, MDS-UPDRS IV, and levodopa-equivalent dose improved by 47.0% (<em>p</em> &lt; 0.001), 77.7% (<em>p</em> = 0.001), 51.1% (<em>p</em> = 0.006), and 44.8% (<em>p</em> = 0.011) compared with preoperatively using this approach.</div></div><div><h3>Conclusions</h3><div>This study shows that sensing-based initial DBS programming for PD is feasible and rapid, and selected clinically effective contacts in most patients, including those with tremor. Technologic innovations and practical developments could improve sensing-based programming.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 3","pages":"Pages 501-510"},"PeriodicalIF":3.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142770558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Closed-Loop Deep Brain Stimulation Platform for Translational Research 用于转化研究的闭环深层脑刺激平台。
IF 3.2 3区 医学
Neuromodulation Pub Date : 2025-04-01 DOI: 10.1016/j.neurom.2024.10.012
Yan Li MEng , Yingnan Nie PhD , Xiao Li PhD , Xi Cheng MCS , Guanyu Zhu MD , Jianguo Zhang MD , Zhaoyu Quan PhD , Shouyan Wang PhD
{"title":"Closed-Loop Deep Brain Stimulation Platform for Translational Research","authors":"Yan Li MEng ,&nbsp;Yingnan Nie PhD ,&nbsp;Xiao Li PhD ,&nbsp;Xi Cheng MCS ,&nbsp;Guanyu Zhu MD ,&nbsp;Jianguo Zhang MD ,&nbsp;Zhaoyu Quan PhD ,&nbsp;Shouyan Wang PhD","doi":"10.1016/j.neurom.2024.10.012","DOIUrl":"10.1016/j.neurom.2024.10.012","url":null,"abstract":"<div><h3>Objective</h3><div>This study aims to facilitate the translation of innovative closed-loop deep brain stimulation (DBS) strategies from theory to practice by establishing a research platform. The platform addresses the challenges of real-time stimulation artifact removal, low-latency feedback stimulation, and rapid translation from animal to clinical experiments.</div></div><div><h3>Materials and Methods</h3><div>The platform comprises hardware for neural sensing and stimulation, a closed-loop software framework for real-time data streaming and computation, and an algorithm library for implementing closed-loop DBS strategies. The platform integrates hardware for both animal and clinical research. The closed-loop software framework handles the entire closed-loop stimulation, including data streaming, stimulation artifact removal, preprocessing, a closed-loop stimulation strategy, and stimulation control. It provides a unified programming interface for both C/C++ and Python, enabling secondary development to integrate new closed-loop stimulation strategies. Additionally, the platform includes an algorithm library with signal processing and machine learning methods to facilitate the development of new closed-loop DBS strategies.</div></div><div><h3>Results</h3><div>The platform can achieve low-latency feedback stimulation control with response times of 6.23 ± 0.85 ms and 6.95 ± 1.11 ms for animal and clinical experiments, respectively. It effectively removed stimulation artifacts and demonstrated flexibility in implementing new closed-loop DBS algorithms. The platform has integrated several typical closed-loop protocols, including threshold-adaptive DBS, amplitude-modulation DBS, dual-threshold DBS and neural state–dependent DBS.</div></div><div><h3>Conclusions</h3><div>This work provides a research tool for rapidly deploying innovative closed-loop strategies for translational research in both animal and clinical studies. The platform’s capabilities in real-time data processing and low-latency control represent a significant advancement in translational DBS research, with potential implications for the development of more effective therapeutic interventions.</div></div>","PeriodicalId":19152,"journal":{"name":"Neuromodulation","volume":"28 3","pages":"Pages 464-471"},"PeriodicalIF":3.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142828726","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}
引用次数: 0
Tipu Zahed Aziz, MD (November 9, 1956–October 25, 2024) Tipu Zahed Aziz,医学博士(1956年11月9日- 2024年10月25日)。
IF 3.2 3区 医学
Neuromodulation Pub Date : 2025-04-01 DOI: 10.1016/j.neurom.2024.12.003
Sean C. Martin DPhil , James J. FitzGerald PhD
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