SCS

SCS
  • 文章类型: Journal Article
    目的:术中神经监测(IONM)的使用已适应于解决脊髓刺激中的安全性和正确引线定位问题。此多中心案例系列旨在结合使用诱发复合动作电位(ECAP)和延迟反应(LR)记录,并将其与使用IONM获得的结果进行比较。特别是肌电图(EMG),用于确认引线放置。本研究旨在建立ECAP之间的相关性,LR,和EMG,并在与IONM一起使用期间发布ECAP和LR的人类记录。
    方法:在两个机构遵循标准神经监测方案,有两个独立的医生和七个病人,作为在ClinicalTrials.gov(NCT02924129)注册的一项更大的正在进行的研究的一部分。进行刺激和记录,顶部和底部,在每个经皮导线上。考虑到ECAP,刺激幅度增加,LR,和EMG阈值。
    结果:ECAP,LRs,所有患者均观察到肌电图信号。植入电极上的LR信号和皮下电极上的EMG信号的开始具有很好的相关性(rs=0.94,p<0.001),中位LR:肌电图值为1.06(N=21)。LR:使用配对的Wilcoxon符号秩检验和独立样本Mann-Whitney检验比较了导线顶部(平均值=0.97,N=8)与底部(平均值=1.15,N=13)的EMG。显着差异和统计学差异(分别为p=0.078和p=0.015)。所有位置的平均LR:ECAP>2,总体约3.5。LR:铅的顶部和底部之间的ECAP显着不同(Wilcoxon检验,p<0.01,N=12)。
    结论:LR与EMG相关;双侧(不一定对称)EMG活动的导联显示LR:ECAP>1.5。LR:ECAP<1,在ECAP之前生成LR/EMG,表明铅过于横向。ECAP和LR的使用有可能保持客观的铅位置,无需使用IONM进行针头放置。
    OBJECTIVE: The use of intraoperative neuromonitoring (IONM) has been adapted to address issues of safety and proper lead positioning in spinal cord stimulation. This multicenter case series seeks to incorporate the use of evoked compound action potential (ECAP) and late response (LR) recording and compare it with the results obtained with IONM, specifically electromyography (EMG), for the confirmation of lead placement. This study aimed to establish a correlation between ECAPs, LR, and EMG and publish human recordings of ECAPs and LR during their use with IONM.
    METHODS: Standard neuromonitoring protocols were followed at two institutions, with two separate physicians and with seven patients, as part of a larger ongoing study registered with ClinicalTrials.gov (NCT02924129). Stimulation and recording were performed, top and bottom, on each percutaneous lead. Stimulation amplitude was increased considering ECAP, LR, and EMG thresholds.
    RESULTS: ECAPs, LRs, and EMG signals were observed in all patients. The onset of LR signals on implanted electrodes and EMG signal on subdermal electrodes was well correlated (rs = 0.94, p < 0.001), with a median LR:EMG value of 1.06 (N = 21). LR:EMG for the top (mean = 0.97, N = 8) vs bottom (mean = 1.15, N = 13) of the lead was compared using a paired Wilcoxon signed rank test and an independent samples Mann-Whitney test, revealing a marginally significant and a statistically significant difference (p = 0.078 and p = 0.015, respectively). Mean LR:ECAP was >2 in all locations and approximately 3.5 overall. LR:ECAP between the top and bottom of the lead was significantly different (Wilcoxon test, p < 0.01, N = 12).
    CONCLUSIONS: LR correlated with EMG; leads with bilateral (not necessarily symmetric) EMG activity showed LR:ECAP > 1.5. An LR:ECAP of <1, with LR/EMG generated before the ECAP, indicated that the lead is too lateral. The use of ECAP and LR has the potential of maintaining objective lead placement, without the need for needle placement with IONM.
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  • 文章类型: Journal Article
    背景:磁共振成像(MRI)条件模式是某些食品和药品管理局(FDA)批准的脊髓刺激(SCS)设备的新功能。然而,关于MRI条件模式的局限性(“MRI安全”)的文献很少,特别是在可能需要紧急MRI的临床情况下。一个这样的限制是负载阻抗,指电路对系统产生的电流的电阻。高阻抗会限制MRI条件模式的能力,对接受MRI的患者造成潜在伤害或使MRI无法完成。
    方法:确定3例,并获得知情同意。所有信息均通过回顾性图表审查获得。
    结果:在此病例系列中,有MRI条件的SCS系统无法置于“MRI安全”设置中的三名患者,在高阻抗的设置中阻止及时完成MRI研究,这三人都需要接受包括CT扫描在内的替代成像,两名患者最终进行了系统移植,一名患者选择在完成扫描后重新植入。
    结论:本系列病例强调了进一步研究SCS系统中阻抗的必要性以及未来MRI使用的潜在局限性。SCS中阻抗的文献综述显示,阻抗变化的装置和生理相关病因均值得植入医师考虑。
    BACKGROUND: Magnetic resonance imaging (MRI) conditional modes are a novel feature for certain Food and Drug Administration (FDA)-approved spinal cord stimulation (SCS) devices. However, there is a paucity of literature around the limitation of MRI-conditional modes (\"MRI safe\"), specifically in clinical scenarios where urgent MRIs may be needed. One such limitation is load impedance, referring to the circuit\'s resistance to the current being generated by the system. High impedance can limit the MRI-conditional mode capability, presenting potential harm to a patient undergoing an MRI or make an MRI unable to be completed.
    METHODS: Three cases were identified, and informed consent was obtained. All information was obtained via retrospective chart review.
    RESULTS: In this case series of three patients where MRI-conditional SCS systems were unable to be placed in \"MRI safe\" settings, preventing timely MRI study completion in the setting of high impedance, all three were required to undergo alternative imaging including CT scans, and two patients ultimately had the system explanted and one chose to be re-implanted after completion of scans.
    CONCLUSIONS: This case series highlights the need for further investigation of impedance in SCS systems and potential limitations for future MRI usage. The review of literature of impedance in SCS shows both device- and physiologic-related etiologies for changes in impedance that warrant consideration by the implanting physician.
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  • 文章类型: Case Reports
    目的:十kHz脊髓刺激(SCS)通常是在放射学参考点T9/T10椎间盘间隙的单双极结构中启动的,以治疗神经性背部和腿部疼痛。级联是一个循环任务,跨整个八触点引线的多双极触点配置。使用更广泛的SCS覆盖范围的潜在优势包括缓解少量铅迁移和减少重新编程的需要。我们在此报告使用Cascade的114例患者的回顾性病例系列的结果。
    方法:收集了超过两年的回顾性数据。我们选择了患有或没有/腿部疼痛的神经性背部患者,并进行了SCS试验。使用数字评定量表(NRS)和患者总体变化印象(PGIC)评分进行疼痛评估,六个月,最后一次随访超过12个月(平均15.1个月)。在试验期间,使用Cascade对患者进行了10kHzSCS编程,除非报告疼痛缓解不足,否则继续。还获得了Cascade编程的发病率和偏差。
    结果:六个月时,在最后一次随访>12个月时,97名(90.6%)有源设备患者中有87名(90.6%)使用Cascade,72名(81%)患者中有58名(81%)使用Cascade。背部NRS显着减少(8.3vs.3.9[p<0.0001],N=97)和腿部疼痛(7.53vs.3.83[p<0.0001],N=77)在6个月和最后一次随访>12个月后(8.3vs.3.95[p<0.0001]N=72),腿(7.53vs.3.534[p<0.0001],N=58)。在6个月时,72%的患者(70/97)的PGIC评分为7分6分或全部7分,在12个月后的最后一次随访中,PGIC评分为68%(49/72)的患者。
    结论:级联是一种有效的编程方法,可能比10kHzSCS的单双极配置有优势,特别是在刺激试验期间。这项研究的结果表明,对于患有神经性背部和腿部疼痛的患者来说,这是一个持久的计划。
    OBJECTIVE: Ten kilohertz spinal cord stimulation (SCS) is usually initiated in a single-bipolar configuration over the radiological reference point T9/T10 intervertebral disc space for neuropathic back and leg pain. Cascade is a duty-cycled, multi-bipolar contact configuration across an entire eight-contact lead. Potential advantages by using a broader area of SCS coverage include mitigation against minor lead migration and a reduction in the need for reprogramming. We report here the results of a retrospective case series of 114 patients using Cascade.
    METHODS: Retrospective data were collected over two years. We selected patients with neuropathic back with or without/leg pain who had a trial of SCS. Pain assessments using Numerical Rating Scales (NRS) and Patient Global Impression of Change (PGIC) scores were collected at baseline, six months, and last follow-up beyond 12 months (mean 15.1 months). Patients were programmed with 10 kHz SCS using Cascade during the trial, which was continued unless reporting inadequate pain relief. Morbidity and deviations from Cascade programming were also obtained.
    RESULTS: At six months, 87 of 97 (90.6%) patients with active devices were using Cascade and 58 of 72 (81%) patients at the last follow-up >12 months. There was a significant reduction in back NRS (8.3 vs. 3.9 [p < 0.0001], N = 97) and leg pain (7.53 vs. 3.83 [p < 0.0001], N = 77) at 6 months and last follow-up >12 months back (8.3 vs. 3.95 [p < 0.0001] N = 72), leg (7.53 vs. 3.534 [p < 0.0001], N = 58). The PGIC score was 6 of 7 or all of 7 in 72% of patients (70/97) at six months and in 68% (49/72) of patients at the last follow-up beyond 12 months.
    CONCLUSIONS: Cascade is an effective programming methodology that may have benefits over a single-bipole configuration for 10 kHz SCS, particularly during a trial of stimulation. Results from this study suggest it is a durable program for patients with neuropathic back and leg pain.
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  • 文章类型: Journal Article
    脊髓刺激(SCS)已被证明是一种经济有效的治疗失败的背部手术综合征(FBSS)。然而,对患者工作能力的影响尚不清楚。
    评估SCS对FBSS患者工作能力的影响,并确定造成永久性残疾的因素。
    研究组由198名工作年龄的SCS患者组成,这些患者在1996年至2014年期间在一个中心进行FBSS试验或植入。对于每个病人来说,3生活控制,与年龄相匹配,性别,出生地,否则由人口登记中心随机选择。有关工作能力的数据是从社会保险机构获得的。患者分为3组:仅SCS试验,SCS永久植入,和SCS植入,但后来被移植。
    对68名患者和8名对照者给予康复补助,平均每月5.2天(95%置信区间[CI]2.4-8.2)和0.2天(95%CI0.05-0.6)(P<0.05)。在后续行动结束时,16(37%),13(33%),25(22%),在SCS试验中,27名(5%)受试者领取残疾抚恤金(DP),SCS移植,永久性SCS,和对照组。与永久性SCS患者相比,仅SCS试验组中的患者使用DP的频率明显更高(比值比2.6;95%CI1.2-5.9;P=0.02)。
    长期使用SCS与病假和DP减少有关。将需要前瞻性研究来评估可能的预测价值。
    Spinal cord stimulation (SCS) has proven to be a cost-effective treatment for failed back surgery syndrome (FBSS). However, the effect on patients\' working capability remains unclear.
    To evaluate the impact of SCS on working capability and to identify the factors behind permanent disability in FBSS patients.
    The study group consisted of 198 working-age patients with SCS trialed or implanted for FBSS in a single center between 1996 and 2014. For each patient, 3 living controls, matched by age, gender, and birthplace, were otherwise randomly selected by the Population Register Center. The data on working ability were obtained from the Social Insurance Institution. Patients were divided into 3 groups: SCS trial only, SCS implanted permanently, and SCS implanted but later explanted.
    A rehabilitation subsidy was given to 68 patients and 8 controls for a mean of 5.2 (95% confidence interval [CI] 2.4-8.2) and 0.2 (95% CI 0.05-0.6) days per month (P < .05). At the end of follow-up, 16 (37%), 13 (33%), 25 (22%), and 27 (5%) subjects were on disability pension (DP) in the SCS trial, SCS explanted, SCS permanent, and control groups. Patients in the SCS trial-only group were significantly more often on DP than were patients with permanent SCS (odds ratio 2.6; 95% CI 1.2-5.9; P = .02).
    Permanent SCS usage was associated with reduced sick leave and DP. Prospective study will be required to assess possible predictive value.
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  • 文章类型: Case Reports
    BACKGROUND: Spinal cord stimulation (SCS) is an evidence-based treatment for chronic neuropathic pain; however, there is a dearth of evidence investigating this modality in patients with tethered cord syndrome.
    METHODS: We present a case of 55-year-old woman with history of lipo-myelomeningocele repair and multiple detethering surgeries who presented with chronic low back and leg pain accompanied by progressive gait dysfunction. After a successful trial, she underwent SCS paddle lead placement that resulted in decrease of her visual analog scale for pain from 9/10 to 0-2/10 as well as daily opioid intake from 90 to 199 mg morphine-equivalent doses to 40 to 60 mg morphine-equivalent doses. On last follow-up she reported 70%-85% relief of her low back and leg pain, better ambulation, and improved quality of life.
    CONCLUSIONS: The literature review identified 2 other case reports of SCS in tethered cord syndrome with similar improvement in pain alleviation.
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  • 文章类型: Journal Article
    Current treatment options for bladder disorders of neurogenic etiology often leave unsatisfactory results. Therefore, new and effective treatments must be investigated. High-frequency spinal cord stimulation (HF-SCS) at 10 kHz has proven to be effective in the treatment of refractory chronic back and leg pain.
    To evaluate the efficacy of HF-SCS at 10 kHz in alleviating lower urinary tract dysfunction and bladder incontinence in 5 patients with underlying neurological disease or spinal cord injury, through retrospective study.
    Urodynamic parameters such as voiding frequency, residual volume, episodes of incontinence, and the patients\' subjective impression impairment of life were assessed and compared pre- and postoperatively. Reduction in pain intensity was assessed as change on the Numeric Rating Scale (NRS).
    All 5 patients had significantly positive outcomes. Episodes of leakage per day improved by 83% on average. Quality of life questionnaires and subjective bother scale revealed an improvement of 36% and 57%, respectively. Individual symptoms among the patient group such as residual volume also responded to the treatment as well. Mean pain NRS of 8.6 cm was reduced to 3.9 cm (55%) at 6 mo follow-up.
    HF-SCS at 10 kHz significantly alleviated symptoms of neurogenic bladder incontinence in patients suffering from neurological disease or spinal cord injury. However, larger and prospective, randomized studies are necessary to make a clear statement regarding the efficacy of this therapy in lower urinary tract dysfunction and bladder incontinence.
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  • 文章类型: Journal Article
    背景:脊髓刺激的术中神经监测使用肌电图(EMG)反应来确定肌层覆盖作为皮肤层覆盖的标志。利用这些响应来确定电极的取向。还可以使用体感诱发电位(SSEP)碰撞测试,其中当刺激被激活时感觉信号减少和/或消除。
    方法:在研究中观察了15例患者。每个制造商至少有三名患者。其中包括雅培BurstDR波形,波士顿科学爆发刺激,美敦力大剂量刺激,和Nevro高频波形。治疗的功效由成功的试验确定。在永久性植入过程中进行的分析,包括传统补品刺激的发现,特定的波形和刺激平台,振幅差,以及肌电图反应和SSEP碰撞测试的结果。
    结果:雅培BurstDR波形产生了最多的发现。产生观察到的EMG反应所需的幅度远低于其他幅度,阈值为传统补品编程中的10-20%。Medtronic高剂量编程和Nevro高频波形没有产生任何可观察到的肌电图反应。AbbottBurstDR波形的独特之处在于远端肌肉群在近端肌肉群之前开始EMG活动,以及过度兴奋现象,充当引物,在返回传统的强直刺激时,以较低的阈值产生信号,具有更强大的响应。EMG反应证明与BurstDR一起传播到一个大的EMG尖峰中,而波士顿科学爆发刺激没有传播,单独的尖峰与传统的补品刺激一致。
    结论:该观察系列显示了波形和刺激之间的明显差异,暗示了不同的作用机制。Nevro高频和AbbottBurstDR波形似乎与传统的强直刺激在作用上最不同,而AbbottsBurstDR似乎是在最低阈值下产生能量效率最高的信号,其传播效应导致过度兴奋或启动刺激状态。
    BACKGROUND: Intraoperative neuromonitoring for spinal cord stimulation uses electromyography (EMG) responses to determine myotomal coverage as a marker for dermatomal coverage. These responses are utilized to determine the orientation of the electrode. Somatosensory evoked potential (SSEP) collision testing can also be used in which sensory signals are decreased and/or eliminated when stimulation is activated.
    METHODS: Fifteen patients were observed in the study. Each manufacturer had a minimum of three patients. Those included were Abbott BurstDR waveform, Boston Scientific burst stimulation, Medtronic high-dose stimulation, and Nevro high-frequency waveform. Efficacy of therapy was determined by a successful trial. Analysis performed during the permanent implant, included findings with traditional tonic stimulation, specific waveform and stimulation platforms, amplitude differences, and findings for both EMG responses and SSEP collision testing.
    RESULTS: The Abbott BurstDR waveform produced the most findings. The amplitudes necessary to generate an observed EMG response were far lower than others, with a threshold of 10-20% of that seen in traditional tonic programming. The Medtronic high-dose programming and Nevro high-frequency waveform did not generate any observable EMG responses. Unique to Abbott BurstDR waveform was the onset of EMG activity in the distal muscle groups prior to proximal ones, as well as a hyperexcitability phenomenon acting as a primer generating signals at lower thresholds with more robust responses when returning to traditional tonic stimulation. EMG responses demonstrated propagation into one large EMG spike with BurstDR, while Boston Scientific burst stimulation had no propagation with separate spikes being consistent with traditional tonic stimulation.
    CONCLUSIONS: This observational series demonstrated distinct differences between the waveforms and stimulation alluding to different mechanisms of action. Nevro high-frequency and Abbott BurstDR waveforms appear to be most different in action from traditional tonic stimulation while Abbotts BurstDR appears to be the most energy efficient generating signals at the lowest thresholds with a propagating effect that leads to a hyperexcitable or primed stimulation state.
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  • 文章类型: Journal Article
    OBJECTIVE: Spinal cord stimulation (SCS) traditionally is thought to require paresthesia, but there is evidence that paresthesia-free stimulation using high-density (HD) parameters might also be effective. The purpose of this study is to evaluate relative effectiveness of conventional, subthreshold HD, and sham stimulation on pain intensity and quality of life.
    METHODS: Fifteen patients with response to conventional stimulation (60 Hz/350 μsec) were screened with a one-week trial of subthreshold HD (1200 Hz/200 μsec/amplitude 90% paresthesia threshold) and enrolled if there was at least 50% reduction on visual analog scale (VAS) for pain. Subjects were randomized into two groups and treated with four two-week periods of conventional, subthreshold HD, and sham stimulation in a randomized crossover design.
    RESULTS: Four of 15 patients responded to subthreshold HD stimulation. Mean VAS during conventional, subthreshold HD, and sham stimulation was 5.32 ± 0.63, 2.29 ± 0.41, and 6.31 ± 1.22, respectively. There was a significant difference in pain scores during the blinded crossover study of subthreshold HD vs. sham stimulation (p < 0.05, Student\'s t-test). Post hoc analysis revealed that subjects reported significantly greater attention to pain during conventional stimulation compared with subthreshold HD stimulation (p < 0.05, Student\'s t-test). All subjects reported a positive impression of change for subthreshold HD stimulation compared with conventional stimulation, and there was a trend toward greater likelihood for response to subthreshold HD stimulation in comparison with sham stimulation (p = 0.07, Fisher\'s exact test). At the end of the trial, all subjects elected to continue to receive subthreshold HD stimulation rather than conventional stimulation.
    CONCLUSIONS: Paresthesia are not necessary for pain relief using commercially available SCS devices, and may actually increase attention to pain. Subthreshold HD SCS represents a viable alternative to conventional stimulation among patients who are confirmed to have a clinical response to it.
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  • 文章类型: Case Reports
    OBJECTIVE: €‚ Postherniorrhaphy pain is a not uncommon, and difficult to treat, pain condition. Success with different methods of neurostimulation has been reported in the literature in the last decade. We assess the use of a new modality of neuromodulation--€”spinal-€peripheral neurostimulation (SPN).
    METHODS: €‚ We report the results of treatment of a patient with bilateral, intractable postherniorrhaphy pain with SPN.
    RESULTS: €‚ Significant reduction in pain and decrease in opioid consumption have been achieved.
    CONCLUSIONS: €‚ SPN can be an effective treatment for postherniorrhaphy pain resistant to conservative management.
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