这项工作得到DFG（Deutsche Forschungsgemeinschaft）资助的合作研究中心1158（SFB1158 From nociception to chronic pain:Structure-Function properties of neural pathways and their reorganization）的部分支持。

注意:所有程序都是作为单独的治疗尝试（"Individualueller Heilversuch"）执行的。并遵守当地的伦理委员会（Ethikkommission Heidelberg）以及关于个人治疗尝试的国家法律。患者被治疗医师广泛告知治疗的性质，程序，风险和益处。在开始手术之前，所有患者都提供书面知情同意书。个人治疗尝试需要得到患者医疗保健服务的报销。这必须由治疗医师在安排程序之前获得。 适应症<ol><li> 在一个或多个单侧三叉神经分支中诊断为慢性，治疗抗性，三叉神经痛感染和/或神经性疼痛。 <ol><li>包括符合以下标准的个体:至少6个月的疼痛持续时间，以及两个或更多个fa标准医疗和/或手术治疗的尝试。 </li><li>关于每日攻击的次数和持续时间以及疼痛药物的类型和剂量（用于永久性和阵发性疼痛）的文件信息。通过询问病人评估他/她现在的状态，通过SF-36问卷来评估生活质量。 注意:SF-36是一个问卷，由八个关于生命质量（ 例如活力，身体疼痛）的领域组成，评级范围从0到100。 </li><li>排除患有任何主要精神病（ 如抑郁症，精神分裂症），医疗禁忌症，手术和全身麻醉的严重医疗条件，钛过敏或局部麻醉剂（ 如 Mepivacain））的个体。 </li></ol></li></ol> 2.试验电极放置<ol><li>将患者置于仰卧位，并将头转向疼痛的对侧。 </li><li>完全disi使用无色皮肤消毒剂对面部区域进行处理。 </li><li>在外科手术区域周围涂抹无菌绒布，以尽量减少污染和感染的风险。 </li><li> 用无菌笔根据患者的信息标记疼痛区域，以计划电极位置和皮肤穿刺位置。 <ol><li>计划皮肤穿刺距离疼痛区域的内侧边界不超过9厘米（Tuhoy插管的长度）。 </li><li>对于第一个三叉神经分支，选择一个位置，在前额的外侧上穿刺皮肤，大约10厘米的外侧和眉头的内侧边界上方1厘米。 </li><li>对于第二个三叉神经分支，选择耳屏前方大约1厘米的位置。 </li><li>对于第三个三叉神经分支，选择位于前面约1厘米，耳屏下方4厘米处的位置进行皮肤穿刺。 </li><li>不要进行2 cm以上的皮肤穿刺耳屏使面神经纤维免受损伤。 </li><li>用无菌手术笔标记植入电极的期望方向以进行指导。 </li></ol></li><li>在计划的皮肤穿刺的每个部位，将1mL局部麻醉剂（ 例如 1％Mepivacain）用20G插管注入皮下组织，并等待几分钟以获得局部麻醉效果。疼痛的感觉不存在，但压力和运动仍然被感知。 </li><li> 在以前标记的位置用14 G Tuhoy针进行皮肤穿刺。将Tuhoy插管的尖端放置在皮肤表面下方约0.5厘米处，以保持在皮下组织内。 <ol><li>取出针头并重复步骤2.5，以防患者在皮肤穿刺部位感到疼痛。 </li></ol></li><li> 将Tuhoy插管按照先前标记的方向轻轻地穿过皮下组织，瞄准疼痛的内侧边界区。 <ol><li>对于第一个三叉神经分支，瞄准平行于眉毛的中线。对于第二个三叉神经分支，瞄准鼻翼。对于第三个三叉分支，瞄准下巴。 </li><li>确保保持0.5厘米的深度，并将Tuhoy针的锋利尖端远离皮肤，以防止任何意外的皮肤穿孔。 </li><li>手动轻轻地弯曲Tuhoy套管，以便在需要时考虑颅骨的曲率。 </li></ol></li><li>取出Tuhoy插管的探针，将测试电极插入Tuhoy针。一旦电极到达Tuhoy针的末端，便会检测到软电阻。 注意:电极长60厘米，直径为1.3毫米。用于刺激的八个触点（每个3mm长）在触头之间以6mm的距离排列成一行。电极通过内部可拆卸的管心针稳定。 </li><li>在保持电极的同时取下Tuhoy插管通过温和的压力朝向痛苦的地区的中间边界的位置。 </li><li>将电极的探针拔出约5厘米，并将触点插入连接到外部神经刺激器的屏蔽电缆的端口。 </li><li>对每个附加电极重复步骤2.6-2.10。 </li><li> 开始测试刺激。告知病人，一旦发生刺激感觉（感觉异常），疼痛区域就会被察觉。 <ol><li>使用医师程序员激活刺激。 </li><li>在30-40Hz的频率和120个脉冲宽度的触点（ 例如， 1+，2，3+，4，5+，6，7+，8）上施加交替的阳极和阴极的双极刺激-180μs。 </li></ol></li><li> 增加刺激幅度，直到患者能够轻松地察觉到刺激而不会痛苦。 注意:患者通常报告振幅0.5〜2V的刺激感知。 <ol><li> w ^atch用于直接肌肉刺激的迹象，如上睑下垂或面部肌肉收缩，表示电极植入太深。 </li><li>询问患者疼痛区域的百分比被感觉异常所覆盖。尝试达到至少80％的感觉异常覆盖率。 </li><li>增加刺激幅度和/或脉搏宽度与医生程序员扩大刺激的领域。 </li><li>在直接肌肉刺激和/或不足的感觉异常覆盖的情况下，停止刺激，将电极与屏蔽电缆断开，去除电极并重复步骤2.6-2.13。 </li></ol></li><li>停止刺激，从屏蔽电缆断开电极，并用镊子将电极保持在适当位置，并完全取下电极的探针。 </li><li> 使用涂抹器的固定装置将电极保持在皮肤穿刺部位的位置。使用不可吸收的3-0丝线缝合到皮肤。 </STRONG&gt; <ol><li>将涂抹器的固定装置一直移动到电极的远端，直到其接触皮肤表面。推动杆将固定片施加到电极上。取下涂抹器。 </li><li>用固定装置将电极缝合到患者的皮肤上，两个单针。 </li></ol></li><li>在皮肤穿刺部位进行无菌悬垂。 </li><li>将电极重新连接到屏蔽电缆。 </li></ol> 3.刺激试验和治疗评估<ol><li>计划刺激方案。 注意:调节活动触点，刺激频率，脉冲宽度和幅度以获得最佳的疼痛缓解。患者的刺激方案会有所不同。然而，双极刺激（电极中交替阴极和阳极）和低频刺激（30-40Hz）在大多数患者中是常见的。 </li><li> 指导患者使用手持式病人滚动打开和关闭刺激并增加或减少刺激。 <ol><li>要打开或关闭刺激并改变刺激幅度，请按下开/关按钮激活手持式病人控制器。将手持式病人控制器放在外部脉冲发生器上，然后按下患者控制器侧面的黑色"通讯"按钮。 </li><li>按下患者控制器侧面的灰色"刺激关闭"按钮，关闭刺激，将白色"刺激"按钮转向刺激。 </li><li>按病人控制器前面的"+"和" - "按钮增加或减少刺激幅度。 注意:患者控制器显示屏上提供有关刺激振幅，刺激状态和电池容量的信息。 </li><li>请病人不断刺激。指示每天关闭刺激1小时以比较pa在有和没有刺激。 </li></ol></li><li>放开患者进行12天的动态刺激试验。 </li><li> 评估在门诊诊所刺激的影响。 <ol><li>要求患者在VAS下用0和10之间的数字进行刺激评估疼痛 注意:视觉模拟量表（VAS）疼痛减少至少50％被认为是成功的试验刺激。 VAS是一个数字评分量表，从0"无疼痛"到10"最难以想象的"，并且是患者评估的主观。成功的进一步措施是:减少攻击频率在50％以上，减少药物和提高生活质量。比较数据与术前状态。 </li></ol></li><li>采取A / P（前后）和颅骨的横向x射线来记录第二步14的电极位置。 </li><li>去除悬垂，切断缝线并取出测试电极。在消毒和检查皮肤穿刺部位后应用新的覆盖物。 </li><li>在成功的试验刺激的情况下，计划植入电极和内部脉冲发生器（IPG）的程序。 注意:在试验电极被去除4-6周后，安排第二次手术，以实现良好的伤口愈合，以最大限度地减少感染的风险，并给予患者时间反映试验刺激期间减少疼痛的程度。 </li><li> 记录第二次手术后IPG的试验刺激期间的有效刺激方案。 <ol><li>将医师程序员天线与外部脉冲发生器连接</li><li>选择程序员显示屏上的"连接"选项</li><li>转到"刺激设置"部分，记录病人的刺激方案。 </li></ol></li></ol>永久性电极植入和IPG <ol><li>在全身麻醉下将患者置于仰卧位。把头转向对侧的疼痛。将枕头放在同侧肩下露出锁骨。 </li><li>在手术开始前20分钟，给予静脉注射单抗抗生素（ 如 2 g头孢唑啉）。 </li><li>刮伤面部痛苦的一面的耳朵周围的区域。去除任何松散的头发。如有必要，请将周围的头发带走，以防止他们进入手术区域。 </li><li>彻底消毒手术区域的面部区域，围绕耳朵向下移动至锁骨区域。 </li><li>使用在门诊预约期间获得的x射线和以前的皮肤穿刺的标记来指示永久电极的期望位置用于引导。 </li><li>在整个手术领域应用无菌悬垂。 </li><li>演出皮肤用14G Tuhoy插管穿刺，并且如先前针对第一试验程序描述的那样植入永久电极。 注意:电极的尺寸和长度与试验电极（长度60厘米，直径1.3毫米，8个触点）相同。 </li><li>在上眼睛区域做一个1厘米长的垂直切口，在那里形成一个小的皮下袋。 </li><li> 插入Tuhoy插管皮下隧道从上耳廓切口到皮肤穿刺部位。去除Tuhoy插管和电极的样式，并将电极的远端插入插管。 注意:第三个三叉神经分支需要两个Tuhoy插管的长度和一个额外的小皮肤切口在眼前区域以完全覆盖距离。 <ol><li>在用镊子将电极保持在适当位置的同时取下Tuhoy插管。 </li><li>使用3-0不可吸收的丝线缝合电极到肌肉筋膜防止电极脱位。 </li><li>如果患者戴眼镜，请将电极固定在位于眼镜框架上方的位置，以防止局部疼痛和皮肤侵蚀。 </li></ol></li><li>执行6厘米长的锁骨下切口，并手动形成皮下袋以容纳IPG。使用双极电钳将任何出血血液凝结。 </li><li> 在隧道内切口插入穿刺矛，并在耳后向皮下隧道穿过上耳切口。 <ol><li>做一个小的后视切口，用于长矛离开皮肤。然后使用第二条矛从上眼眶隧道切除至后视切口。 </li><li>取下长矛的风格并插入电极，直到埋在皮下组织中，没有任何环路或扭结。 </li><li>在将电极保持在位置的同时将其从锁骨下切口中拉出来取下矛用镊子</li><li>注意不要用隧道矛刺穿皮肤（特别是以前曾经接受手术治疗微血管减压术的患者，因为他们有一个后眼瘢痕）。 </li></ol></li><li>将电极连接到IPG上，并用扭矩螺丝固定。 </li><li> 用不可吸收的丝线缝线（3-0）将IPG缝合到胸大肌筋膜，以防止IPG脱位。 <ol><li>检查系统阻抗以检测任何有故障的连接或损坏的电极触点。 </li><li>将医师程序员的天线放在无菌悬垂中，并将其置于IPG上。使用IPG连接编程器，并转到"检查电极阻抗"部分。 注意:250欧姆以下的低阻抗指示开路。超过500 OHM的高阻抗表明电极与IPG或电极断裂的连接不足。 </li></ol></li><li>皮肤接触皮肤在面部区域可吸收3-0缝合线和不可吸收的3-0皮肤缝合线，并可在IPG现场吸收皮肤缝线。 </li><li>消毒所有伤口，用盐水清洁手术区域，并应用无菌悬垂。 </li></ol> 5.术后护理注意:将患者转移到病房，观察隔夜，并给予口服止痛药。 <ol><li> 使用试验刺激的刺激方案对IPG进行编程（见3.8）。 <ol><li>将医师程序员的天线放在IPG上的皮肤上，并选择"连接"选项与神经刺激器通信。 </li><li>在"刺激设置"部分插入试验刺激结束时记录的刺激方案。 </li><li>根据患者关于感觉异常覆盖的陈述调整刺激设置。增加幅度和/或pulse宽度实现更广泛的刺激。在直接肌肉刺激的痛苦刺激的情况下减小幅度和/或脉搏宽度。 </li><li>在试验刺激期间向患者提供个人患者控制器，以使他或她能够打开或关闭刺激或改变刺激幅度。 </li><li>如果植入可充电IPG，请指导患者如何使用手持设备检查电池容量以及如何执行充电过程。 注意:患者接受口服预防性术后抗生素（ 例如每日两次，每次两次，960mg三甲氧甲脒磺胺甲恶唑）5天。 </li></ol></li><li>手术后第二天放疗患者。 </li><li>在门诊诊所进行手术后7天取出缝合线。 </li><li>在手术后4周和12周进行随访，以评估刺激效果，并根据需要改变刺激设置。 </li></ol>

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J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Trigeminal+branch+stimulation+for+the+treatment+of+intractable+craniofacial+pain.">Trigeminal branch stimulation for the treatment of intractable craniofacial pain.</a> J Neurosurg. 123 (1), 283-288 (2015).</li><li>Verrills, P., Rose, R., Mitchell, B., Vivian, D., Barnard, A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Peripheral+nerve+field+stimulation+for+chronic+headache:+60+cases+and+long-term+follow-up.">Peripheral nerve field stimulation for chronic headache: 60 cases and long-term follow-up.</a> Neuromodulation. 17 (1), 54-59 (2014).</li><li>Slotty, P. J., Bara, G., Vesper, J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+surgical+technique+of+occipital+nerve+stimulation.">The surgical technique of occipital nerve stimulation.</a> Acta Neurochir. (Wien). 157 (1), 105-108 (2015).</li><li>Boccard, S. G., Pereira, E. A., Moir, L., Aziz, T. Z., Green, A. L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Long-term+outcomes+of+deep+brain+stimulation+for+neuropathic+pain.">Long-term outcomes of deep brain stimulation for neuropathic pain.</a> Neurosurgery. 72 (2), 221-230 (2013).</li><li>Rasche, D., Ruppolt, M., Stippich, C., Unterberg, A., Tronnier, V. M. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Motor+cortex+stimulation+for+long-term+relief+of+chronic+neuropathic+pain:+a+10+year+experience.">Motor cortex stimulation for long-term relief of chronic neuropathic pain: a 10 year experience.</a> Pain. (1-2), 43-52 (2006).</li><li>Merhkens, J. H., Steude, U. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Chronic+electrostimulation+of+the+trigeminal+ganglion+in+trigeminal+neuropathy:+current+state+and+future+prospects.">Chronic electrostimulation of the trigeminal ganglion in trigeminal neuropathy: current state and future prospects.</a> Acta Neurochir Suppl. 97 (Pt 2), 91-97 (2007).</li><li>Slavin, K. V., Colpan, M. E., Munawar, N., Wess, C., Nersesyan, H. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Trigeminal+an+occipital+peripheral+nerve+stimulation+for+craniofacial+pain:+a+single-institution+experience+and+review+of+the+literature.">Trigeminal an occipital peripheral nerve stimulation for craniofacial pain: a single-institution experience and review of the literature.</a> Neurosurg Focus. 21 (6), E5 (2006).</li><li>Cheng, J. S., Lim, D. A., Chang, E. F., Barbaro, N. M. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=A+Review+of+percutaneous+treatments+for+trigeminal+neuralgia.">A Review of percutaneous treatments for trigeminal neuralgia.</a> Neurosurgery. 10, 25-33 (2014).</li></ol>

作者没有什么可以披露的。

通过皮下三叉神经域刺激（sTNFS），我们提出了一种手术技术，用于对不同病因的三叉神经的慢性难治性疼痛进行微创神经调节。 减少并发症彻底消毒整个手术领域至关重要。任何不必要的皮肤穿孔可能会随着系统的连续损失而增加设备感染的风险。医生应始终注意电极的植入深度，因为当植入距离皮肤表面0.5厘米以下时，它们会侵蚀皮肤。使用固定装置固定电极应彻底执行...

用于治疗三叉神经痛的神经外科手术与潜在病因相同大小多样。在三叉神经微血管减压（MVD） 1脑干根进入区动脉压缩造成的经典三叉神经痛（TN）的情况下，高度有效。 加速器神经节的经皮破坏性技术（如射频热凝，甘油注射或气囊压缩2 ）和三叉神经痛立体定向放射外科手术可应用于无神经血管疾病或无明显外科手术禁忌症的情况。然而，所有技术都与某些疼痛复发率相关。此外，治疗本身具有导致神经性疼痛或甚至疼痛的创伤后三叉神经病变的神经损伤的风险。最后，三叉神经痛来源于中心（例如脑卒中后疼痛）将不会对Gasser神经节的MVD或破坏性技术作出反应，但需要通过神经调节治疗，如深部脑刺激（DBS）或运动皮层刺激（MCS）。 神经调节是用于外科技术的术语，其似乎改变神经活动而不引起不可逆的组织损伤。神经调节治疗是可逆的，适应性的，通常可以间断或连续地将电流施加到外周或中枢神经系统的部分。有几种认证（CE和/或FDA批准）治疗可用于治疗躯干和四肢的慢性和/或神经性疼痛，如硬膜外脊髓刺激（SCS），周围神经区域刺激（PNFS）或背根神经节刺激（DRG） 4 。然而，目前没有CE或FDA批准的治疗可用于慢性神经性面部和三叉神经痛/ P&gt; 针对不同来源的慢性面部疼痛患者，深部脑刺激（DBS）和运动皮层刺激（MCS）已被应用于多种病例系列。然而，这两种技术都具有高度的复杂性，并且需要特殊的医师专长。当保守治疗失败并且需要避免破坏性技术时，需要简单，成本效益和有效的慢性三叉神经和面部疼痛的神经调节。 除外科手术外，一系列非侵入性或临时形式的神经调节可用于治疗慢性疼痛（ 例如 PENS:经皮电神经刺激，TENS:经皮电神经刺激，TMS:经颅磁刺激）。 皮下周围神经域刺激（sPNFS）是神经调节的最小侵入形式。一个或多个电极a重新置于疼痛区域的皮下组织中。应用持续的电刺激来产生令人愉悦的感觉异常，涵盖痛苦的区域。确切的行动机制是未知的。然而，尽管存在所有缺点，但类似的机制，如门控制理论，或其变化，假设抑制性纤维的伤害性输入的调制是最常用的。另外，讨论了周围神经纤维的局部去极化阻滞，其兴奋性降低以及关于炎性蛋白质的微环境变化。 如在大多数神经调节程序中，执行连接到脉冲发生器的外部电极的测试试验以评估在完全植入式脉冲发生器（IPG）被放置在皮下组织中并连接到电极之前的有效性，作为用于刺激的电源治疗情况CCESS。没有一个积极的测试试验的一般定义，但在视觉模拟量表（VAS）上减少50％或更多的疼痛通常被认为是标志性标准。此外，减少口服止痛药物或提高生活质量可能是有利于植入永久性系统的因素。 外周神经域刺激被认证用于慢性腰痛8 ，并已被用于局部慢性疼痛综合征（ 例如 ，发作后疼痛）。它也用作枕骨神经刺激（ONS）治疗慢性偏头痛和丛集性头痛9 。几项非随机研究表明，三叉神经根皮瘤中sPNFS用于不同来源的慢性和神经性难治性疼痛（经典TN，非典型TN，疱疹后三叉神经病，MS相关性三叉神经病，持续性特发性面部疼痛） 10 </sup&gt; ， 11，12 。 皮下三叉神经区域刺激（sTNFS）容易且快速。与DBS或MCS相反，sTNFS可以作为门诊手术（如果报销）执行。没有颅内或硬膜外出血的风险。癫痫发作不发生。试验刺激是在动态的环境下进行的，以便病人能够在执行他的日常生活中评估刺激效果，而不是绑在医院病床上。无需广泛的术前或术前成像来确定电极的正确位置。在考虑神经病理或中枢性疼痛患者的MCS或DBS之前，sTNFS可以被认为是在应用经皮破坏性手术或作为较少侵入性类型的神经调节之前调节疼痛感知和加工的治疗选择。

<table border="0" cellpadding="0" cellspacing="0" width="1257">
	<tbody>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">myStim Patient Programmer</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">97740</td>
			<td style="width:709px;">enables the patient to turn off and on stimulation</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Prime Advanced</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">97702</td>
			<td>non-rechargeable IPG as powersource for stimulation</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Restore Ultra</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">97712</td>
			<td>rechargeable IPG as powersource for stimulation</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Charging System</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">97754</td>
			<td>used by the patient to recharge the Restore Ultra IPG</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">N&#39;Vision Programmer</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">8840</td>
			<td>used by the physician to program the IPG and define stimulation parameters</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">External Neurostimulator</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">37022</td>
			<td>external IPG as powersource for trial stimulation with externalized electrodes</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Advanced Screening Cable</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">355531</td>
			<td>connects externalized electrodes to the external neurostimulator during trial stimulation</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Tunnelling Spear 60cm</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">3655-60</td>
			<td>used to subcutaneously tunnel the permanent electrodes to an infraclavicular pocket that houses the IPG</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Tunnelling Spear 38cm</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">3655-38</td>
			<td>used to subcutaneously tunnel the permanent electrodes to an infraclavicular pocket that houses the IPG</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Tuhoy Cannula</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">3550-32</td>
			<td>14 gauge Epidural Tuhoy cannula (length 9cm) to subcutaneously implant the electrodes</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">InjexFixation Device</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">97791 / 97792</td>
			<td>used to fixate the electrodes on the skin or on the muscle fascia</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Octad Compact</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">3878-60</td>
			<td>permanent electrode (length 60cm) implanted in the subcutaneous tissue with 8 contacts</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Vectris Trial Lead</td>
			<td style="width:213px;">Medtronic</td>
			<td style="width:119px;">977D260</td>
			<td>externalized electrode (length 60cm) used during the stimulation trial</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Ethilon*II 3-0</td>
			<td style="width:213px;">Ethicon</td>
			<td style="width:119px;">EH7933H</td>
			<td>non-absorbable suture for skin closure</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Seide 2-0</td>
			<td style="width:213px;">Resorba</td>
			<td style="width:119px;">40221</td>
			<td>non-absorbable silk suture to fixate electrodes and IPG</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Resolon DS21</td>
			<td style="width:213px;">Resorba</td>
			<td style="width:119px;">881413</td>
			<td>absorbable suture for subcutaneous wound closure</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Feather disposable scalpel</td>
			<td style="width:213px;">Feather</td>
			<td style="width:119px;">5205052</td>
			<td>single use scalpel for skin incision and suture cutting</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Scandicain 1%</td>
			<td style="width:213px;">Astra Zeneca</td>
			<td style="width:119px;">23186</td>
			<td>1% Mepivacain solution for local anesthesia</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Cosmopor E steril 10x6</td>
			<td style="width:213px;">Hartmann</td>
			<td style="width:119px;">900871</td>
			<td>Sterile draping for IPG wound</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Cosmopor E steril 7,2x5</td>
			<td style="width:213px;">Hartmann</td>
			<td style="width:119px;">900870</td>
			<td>Sterile draping for skin punctures and small incisions</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Foliodrape Comfort 50x50</td>
			<td style="width:213px;">Hartmann</td>
			<td style="width:119px;">252302</td>
			<td>Sterile draping for the surgical field</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Cephazolin</td>
			<td style="width:213px;">Fresenius</td>
			<td style="width:119px;">6062403.00.00</td>
			<td>Single shot perioperative antibiotic</td>
		</tr>
		<tr height="42">
			<td height="42" style="height:42px;width:216px;">Kepinol forte 800mg/160mg</td>
			<td style="width:213px;">Dr. R. Pfleger Chemische Fabrik</td>
			<td style="width:119px;">2485177</td>
			<td>Postoperative prophylactic oral antibiotic</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Poly-Alcohol</td>
			<td style="width:213px;">Antiseptica</td>
			<td style="width:119px;">UN1219</td>
			<td>Coloured skin disinfectant used during the permanent implantation</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:216px;">Cutasept F</td>
			<td style="width:213px;">Bode</td>
			<td style="width:119px;">976800</td>
			<td>Un-Coloured skin disinfectant used during the trial implantation</td>
		</tr>
	</tbody>
</table>

subcutaneous trigeminal nerve field stimulation for refractory facial pain

慢性或神经性三叉神经面痛可能是具有挑战性的治疗。当保守治疗失败时，应适用神经外科手术。慢性面部疼痛的神经调节技术包括深层脑刺激和运动皮层刺激，这些复杂的表现。皮下神经域刺激被认证为慢性背痛，是神经调节的最小侵入形式。我们应用这种技术治疗慢性和神经性三叉神经痛作为个体治疗概念。首先，进行试验刺激。在局部麻醉下将皮下引线置于疼痛的三叉神经皮肤。引线连接到应用恒定刺激的外部神经刺激器。患者接受12天门诊试验以评估刺激的效果。试验后电极被去除。如果患者报告疼痛减轻至少50％的强度和/或攻击频率，则减少用药或提高生活质量，定期进行永久植入。在全身麻醉下植入新电极，并皮下隧道穿入锁骨内部脉冲发生器。患者能够根据需要打开和关闭刺激并增加或减少刺激幅度。 这种技术代表了三叉神经痛的其他更具侵入性的神经调节手段，如运动皮层刺激或深部脑刺激的最小侵入性替代方法。

<html>由于皮下三叉神经域刺激（sTNFS）不是标准治疗，与其他疾病相比，潜在受益的患者数量相当小，所以只有较小的病例系列表现出sTNFS的结果。在一个系列中，10例患者接受了sTNFS的检测刺激。八名患者对治疗作出反应，并接受电极和IPG 11的永久植入。患者患有三叉神经痛，与多发性硬化有关的三叉神经病变，疱疹后三叉神经病，放射性三叉神经病和?...

Watch this Scientific Journal Video about Subcutaneous Trigeminal Nerve Field Stimulation for Refractory Facial Pain at JoVE.com

Subcutaneous Trigeminal Nerve Field Stimulation for Refractory Facial Pain

当医疗或标准治疗失败时，治疗慢性或神经性面部疼痛可能具有挑战性。皮下神经域刺激是神经调节的最小侵入形式，用于慢性背痛。我们应用这项技术治疗慢性和神经性三叉神经面部疼痛。

皮下三叉神经场刺激难治性面部疼痛

Chronic or neuropathic trigeminal facial pain can be challenging to treat. Neurosurgical procedures should be applied when conservative treatment fails. ...

subcutaneous-trigeminal-nerve-field-stimulation-for-refractory-facial

Research

JoVE Journal

Medicine

18.6K 次观看.  University Hospital Heidelberg. 当医疗或标准治疗失败时，治疗慢性或神经性面部疼痛可能具有挑战性。皮下神经域刺激是神经调节的最小侵入形式，用于慢性背痛。我们应用这项技术治疗慢性和神经性三叉神经面部疼痛。 

视频: Subcutaneous Trigeminal Nerve Field Stimulation for Refractory Facial Pain

Chronic Constriction of the Sciatic Nerve and Pain Hypersensitivity Testing in Rats

Chronic neuropathic pain, resulting from damage to the central or peripheral nervous system, is a prevalent and debilitating condition, affecting 7-18% of the population1,2. Symptoms include spontaneous (tingling, burning, electric-shock like) pain, dysaesthesia, paraesthesia, allodynia (pain resulting from normally non-painful stimuli) and hyperalgesia (an increased response to painful stimuli). The sensory symptoms are co-morbid with behavioural disabilities, such as insomnia and depression. To study chronic neuropathic pain several animal models mimicking peripheral nerve injury have been developed, one of the most widely used is Bennett and Xie's (1988) unilateral sciatic nerve chronic constriction injury (CCI)3 (Figure 1). Here we present a method for performing CCI and testing pain hypersensitivity.
CCI is performed under anaesthesia, with the sciatic nerve on one side exposed by making a skin incision, and cutting through the connective tissue between the gluteus superficialis and biceps femoris muscles. Four chromic gut ligatures are tied loosely around the sciatic nerve at 1 mm intervals, to just occlude but not arrest epineural blood flow. The wound is closed with sutures in the muscle and staples in the skin. The animal is then allowed to recover from surgery for 24 hrs before pain hypersensitivity testing begins.
For behavioural testing, rats are placed into the testing apparatus and are allowed to habituate to the testing procedure. The area tested is the mid-plantar surface of the hindpaw (Figure 2), which falls within the sciatic nerve distribution. Mechanical withdrawal threshold is assessed by mechanically stimulating both injured and uninjured hindpaws using an electronic dynamic plantar von Frey aesthesiometer or manual von Frey hairs4. The mechanical withdrawal threshold is the maximum pressure exerted (in grams) that triggers paw withdrawal. For measurement of thermal withdrawal latency, first described by Hargreaves et al (1988), the hindpaw is exposed to a beam of radiant heat through a transparent glass surface using a plantar analgesia meter5,6. The withdrawal latency to the heat stimulus is recorded as the time for paw withdrawal in both injured and uninjured hindpaws. Following CCI, mechanical withdrawal threshold, as well as thermal withdrawal latency in the injured paw are both significantly reduced, compared to baseline measurements and the uninjured paw (Figure 3). The CCI model of peripheral nerve injury combined with pain hypersensitivity testing provides a model system to investigate the effectiveness of potential therapeutic agents to modify chronic neuropathic pain. In our laboratory, we utilise CCI alongside thermal and mechanical sensitivity of the hindpaws to investigate the role of neuro-immune interactions in the pathogenesis and treatment of neuropathic pain.

Due to the simplicity of surgery and the robust behavioural outcome, chronic constriction of the sciatic nerve is one of the pre-eminent animal models of neuropathic pain. Within 24 hrs following surgery, pain hypersensitivity is established and can be quantitatively measured using a von Frey aesthesiometer (mechanical test) and plantar analgesia meter (thermal test).

慢性缩窄大鼠坐骨神经疼痛过敏测试

Chronic neuropathic pain, resulting from damage to the central or peripheral nervous system, is a prevalent and debilitating condition, affecting 7-18% of ...

科研

医学

Breathing-controlled Electrical Stimulation (BreEStim) for Management of Neuropathic Pain and Spasticity

Electrical stimulation (EStim) refers to the application of electrical current to muscles or nerves in order to achieve functional and therapeutic goals. It has been extensively used in various clinical settings. Based upon recent discoveries related to the systemic effects of voluntary breathing and intrinsic physiological interactions among systems during voluntary breathing, a new EStim protocol, Breathing-controlled Electrical Stimulation (BreEStim), has been developed to augment the effects of electrical stimulation. In BreEStim, a single-pulse electrical stimulus is triggered and delivered to the target area when the airflow rate of an isolated voluntary inspiration reaches the threshold. BreEStim integrates intrinsic physiological interactions that are activated during voluntary breathing and has demonstrated excellent clinical efficacy. Two representative applications of BreEStim are reported with detailed protocols: management of post-stroke finger flexor spasticity and neuropathic pain in spinal cord injury.

Breathing-controlled Electrical Stimulation BreEStim for Management of Neuropathic Pain and Spasticity

The purpose is to present a new method, breathing-control electrical stimulation (BreEStim) for management of neuropathic pain and spasticity.

呼吸控制电气的刺激（BreEStim）的神经性疼痛和痉挛的管理

Electrical stimulation (EStim) refers to the application of electrical current to muscles or nerves in order to achieve functional and therapeutic goals. ...

The Sciatic Nerve Cuffing Model of Neuropathic Pain in Mice

Neuropathic pain arises as a consequence of a lesion or a disease affecting the somatosensory system. This syndrome results from maladaptive changes in injured sensory neurons and along the entire nociceptive pathway within the central nervous system. It is usually chronic and challenging to treat. In order to study neuropathic pain and its treatments, different models have been developed in rodents. These models derive from known etiologies, thus reproducing peripheral nerve injuries, central injuries, and metabolic-, infectious- or chemotherapy-related neuropathies. Murine models of peripheral nerve injury often target the sciatic nerve which is easy to access and allows nociceptive tests on the hind paw. These models rely on a compression and/or a section. Here, the detailed surgery procedure for the &#34;cuff model&#34; of neuropathic pain in mice is described. In this model, a cuff of PE-20 polyethylene tubing of standardized length (2 mm) is unilaterally implanted around the main branch of the sciatic nerve. It induces a long-lasting mechanical allodynia, i.e., a nociceptive response to a normally non-nociceptive stimulus that can be evaluated by using von Frey filaments. Besides the detailed surgery and testing procedures, the interest of this model for the study of neuropathic pain mechanism, for the study of neuropathic pain sensory and anxiodepressive aspects, and for the study of neuropathic pain treatments are also discussed.

Neuropathic pain is a consequence of a lesion or disease affecting the somatosensory system. The &#8220;cuff model&#8221; of neuropathic pain in mice consists of the implantation of a polyethylene cuff around the main branch of the sciatic nerve. Mechanical allodynia is tested using von Frey filaments.

神经病理性疼痛小鼠坐骨神经掴型号

Neuropathic pain arises as a consequence of a lesion or a disease affecting the somatosensory system. This syndrome results from maladaptive changes in ...

Facial Nerve Axotomy in Mice: A Model to Study Motoneuron Response to Injury

The goal of this surgical protocol is to expose the facial nerve, which innervates the facial musculature, at its exit from the stylomastoid foramen and either cut or crush it to induce peripheral nerve injury. Advantages of this surgery are its simplicity, high reproducibility, and the lack of effect on vital functions or mobility from the subsequent facial paralysis, thus resulting in a relatively mild surgical outcome compared to other nerve injury models. A major advantage of using a cranial nerve injury model is that the motoneurons reside in a relatively homogenous population in the facial motor nucleus in the pons, simplifying the study of the motoneuron cell bodies. Because of the symmetrical nature of facial nerve innervation and the lack of crosstalk between the facial motor nuclei, the operation can be performed unilaterally with the unaxotomized side serving as a paired internal control. A variety of analyses can be performed postoperatively to assess the physiologic response, details of which are beyond the scope of this article. For example, recovery of muscle function can serve as a behavioral marker for reinnervation, or the motoneurons can be quantified to measure cell survival. Additionally, the motoneurons can be accurately captured using laser microdissection for molecular analysis. Because the facial nerve axotomy is minimally invasive and well tolerated, it can be utilized on a wide variety of genetically modified mice. Also, this surgery model can be used to analyze the effectiveness of peripheral nerve injury treatments. Facial nerve injury provides a means for investigating not only motoneurons, but also the responses of the central and peripheral glial microenvironment, immune system, and target musculature. The facial nerve injury model is a widely accepted peripheral nerve injury model that serves as a powerful tool for studying nerve injury and regeneration.

We present a surgical protocol detailing how to perform a cut or crush axotomy on the facial nerve in the mouse. The facial nerve axotomy can be employed to study the physiological response to nerve injury and test therapeutic techniques.

面神经干切断小鼠:模型，研究运动神经元损伤反应

The goal of this surgical protocol is to expose the facial nerve, which innervates the facial musculature, at its exit from the stylomastoid foramen and ...

Chronic Constriction Injury of the Rat's Infraorbital Nerve (IoN-CCI) to Study Trigeminal Neuropathic Pain

Animal models are important tools to study the pathophysiology and pharmacology of neuropathic pain. This manuscript describes the surgical and behavioral procedures to study trigeminal neuropathic pain in rats. To meet the specificity of trigeminal neuropathic pain syndromes, the infraorbital nerve (IoN) is subjected to a chronic constriction injury (CCI) by loosely ligating the nerve. An intra-orbital approach is presented here to expose and ligate the IoN in the orbital cavity. After IoN ligation, rats exhibit changes in spontaneous behavior and in response to von Frey hair stimulation that are indicative of persistent pain and mechanical allodynia. Two phases can be defined in the development of the behavioral changes. During the first week following IoN-CCI (phase 1), rats show an increased and asymmetric face grooming activity, i.e., with face wash strokes primarily directed to the nerve-injured IoN territory. A distinction is made between face grooming behavior that is part of a more general body grooming behavior, which remains largely unaffected by IoN-CCI, and face grooming that is neither preceded nor followed by body grooming, which is significantly increased after IoN-CCI. During this period, responsiveness to mechanical stimulation of the IoN territory is reduced. This hyporesponsiveness is abruptly replaced by an extreme hyperresponsiveness whereby even very weak stimulus intensities provoke nocifensive behavior (phase 2). The phenomenological similarities between these behavioral alterations and reported signs of facial pain (i.e., responses to noxious stimulation of the face) suggest the presence of dysesthesia/paresthesia and mechanical allodynia in the ligated IoN territory.

Chronic Constriction Injury of the Rat's Infraorbital Nerve IoN-CCI to Study Trigeminal Neuropathic Pain

This manuscript describes a rodent model to study trigeminal neuropathic pain. The methods described include surgical procedures to perform a chronic constriction injury of the rat&#8217;s infraorbital nerve and the post-surgical behavioral tests to measure the changes in spontaneous and evoked behavior that are indicative of persistent pain and allodynia.

老鼠的眶下神经（ION-CCI）研究三叉神经性疼痛性损伤

Animal models are important tools to study the pathophysiology and pharmacology of neuropathic pain. This manuscript describes the surgical and behavioral ...

Network Analysis of Foramen Ovale Electrode Recordings in Drug-resistant Temporal Lobe Epilepsy Patients

Approximately 30% of epilepsy patients are refractory to antiepileptic drugs. In these cases, surgery is the only alternative to eliminate/control seizures. However, a significant minority of patients continues to exhibit post-operative seizures, even in those cases in which the suspected source of seizures has been correctly localized and resected. The protocol presented here combines a clinical procedure routinely employed during the pre-operative evaluation of temporal lobe epilepsy (TLE) patients with a novel technique for network analysis. The method allows for the evaluation of the temporal evolution of mesial network parameters. The bilateral insertion of foramen ovale electrodes (FOE) into the ambient cistern simultaneously records electrocortical activity at several mesial areas in the temporal lobe. Furthermore, network methodology applied to the recorded time series tracks the temporal evolution of the mesial networks both interictally and during the seizures. In this way, the presented protocol offers a unique way to visualize and quantify measures that considers the relationships between several mesial areas instead of a single area.

This protocol describes a procedure to track the evolution of mesial network measures in temporal lobe epilepsy (TLE) patients. It is based on the combination of intracranial recordings with a novel numerical technique for data analysis. Specifically, we present a protocol for network analyses of foramen ovale recordings.

在耐药性颞叶癫痫患者卵圆孔电极记录的网络分析

Approximately 30% of epilepsy patients are refractory to antiepileptic drugs. In these cases, surgery is the only alternative to eliminate/control ...

MRI-guided Focused Ultrasound Thalamotomy for Patients with Medically-refractory Essential Tremor

Essential tremor (ET) is the most common type of tremor in adults. While ET does not result in decreased life expectancy, the disabilities associated with ET can have a significant impact on quality of life, mood, functional activities, and socialization. Patients suffering from ET not sufficiently treated with first line medications may be eligible for alternative strategies such as deep brain stimulation, radiofrequency ablation, and MRI guided focused ultrasound (MRgFUS). High-intensity MRgFUS is an emerging modality to treat ET, its attraction for patients being that it is noninvasive and associated with short recovery time, as patients are home the day after treatment. While MRgFUS centers are still limited, it will become important for clinicians to consider MRgFUS as a treatment alternative, particularly in the case of a patient for whom open surgery is contraindicated. This article outlines the steps of patient selection, equipment setup, sonication, and post-treatment follow-up, as well as critical steps to be aware of when performing a MRgFUS procedure.

High-intensity MRI guided focused ultrasound is an emerging noninvasive technique to precisely ablate brain tissue. It has been shown to be safe and effective in treating medically-refractory essential tremor. This article describes the protocol for thalamotomy from patient selection to equipment setup to post-treatment follow-up.

MRI 引导下聚焦超声丘脑治疗难治性原发性震颤

Essential tremor (ET) is the most common type of tremor in adults. While ET does not result in decreased life expectancy, the disabilities associated with ...

Cavernous Nerve Stimulation and Recording of Intracavernous Pressure in a Rat

The stimulation of the cavernous nerve (CN) and measurement of intracavernous pressure (ICP) have been used extensively to test and evaluate therapies for erectile dysfunction. However, the methods used vary between laboratories, and pitfalls still exist. The goal of this study was to describe a surgical technique that would provide a reliable and reproducible model. By exposing the ischiocavernosus muscle at its point of insertion on the ischial tuberosity, the penile crus could be cannulated with minimal dissection and injury to the structures involved in erectile function. Repeated stimulation of the CN, without the need for lifting and drying, was achieved by using a 125 &#181;m bipolar silver electrode and biocompatible silicon glue to isolate the electrode-nerve complex. This method prevents neuropraxia by reducing stretching and drying the nerve and provides complete isolation of the nerve, negating electrical leakage and preventing stimulation of alternative pathways.

This study describes a simplified surgical procedure and technique for performing cavernous nerve stimulation with the isolation of the nerve-electrode complex using silicone glue and intracavernous pressure measurement.

大鼠海绵状神经刺激与海绵压力记录

The stimulation of the cavernous nerve (CN) and measurement of intracavernous pressure (ICP) have been used extensively to test and evaluate therapies for ...

Vagus Nerve Stimulation As an Adjunctive Neurostimulation Tool in Treatment-resistant Depression

Vagus nerve stimulation (VNS) is an approved neurostimulation therapy. The purpose of the method is to treat patients with therapy-resistant depression (TRD). VNS exhibits antidepressive and stabilizing effects. This method is particularly useful as a long-term treatment, in which up to two-thirds of patients respond. The vagus nerve stimulator is positioned on the left vagus nerve during a surgical procedure and is activated telemetrically by a wand connected to a handheld computerized device. The treating physician can perform various adjustments of the vagus nerve stimulator during in-office visits (e.g., by modifying stimulation intensity or stimulation frequency) to achieve maximum therapeutic effects with low side effects. Set-up of the device usually takes several months. Typical side effects include wound infection, temporary salivation, coughing, paralysis of the vocal cords, bradycardia, or even asystole. The patient can stop the VNS by placing a magnet over the generator. The current protocol describes delivery of the specific stimulation tool and methods for adjusting the tuning parameters to achieve the best remission rates in patients with TRD.

Vagus nerve stimulation (VNS) has been shown to be effective as an adjunct treatment for treatment-resistant depression (TRD). VNS leads to antidepressive and antisuicidal effects and quality of life improvements. This protocol offers a step-by-step guide to managing and adjusting a vagus nerve stimulator for efficient treatment of TRD.

迷走神经刺激作为抗抑郁抑郁症的辅助神经刺激工具

Vagus nerve stimulation (VNS) is an approved neurostimulation therapy. The purpose of the method is to treat patients with therapy-resistant depression ...

Partial Sciatic Nerve Ligation: A Mouse Model of Chronic Neuropathic Pain to Study the Antinociceptive Effect of Novel Therapies

Management of chronic pain remains challenging to this day, and current treatments are associated with adverse effects, including tolerance and addiction. Chronic neuropathic pain results from lesions or diseases in the somatosensory system. To investigate potential therapies with reduced side effects, animal pain models are the gold standard in preclinical studies. Therefore, well-characterized and well-described models are crucial for the development and validation of innovative therapies. 
Partial ligation of the sciatic nerve (pSNL) is a procedure that induces chronic neuropathic pain in mice, characterized by mechanical and thermal hypersensitivity, ongoing pain, and changes in limb temperature, making this model a great fit to study neuropathic pain preclinically. pSNL is an advantageous model to study neuropathic pain as it reproduces many symptoms observed in humans with neuropathic pain. Furthermore, the surgical procedure is relatively fast and straightforward to perform. Unilateral pSNL of one limb allows for comparison between the ipsilateral and contralateral paws, as well as evaluation of central sensitization. 
To induce chronic neuropathic hypersensitivity, a 9-0 non-absorbable nylon thread is used to ligate the dorsal third of the sciatic nerve. This article describes the surgical procedure and characterizes the development of chronic neuropathic pain through multiple commonly used behavioral tests. As a plethora of innovative therapies are now being investigated to treat chronic pain, this article provides crucial concepts for standardization and an accurate description of surgeries required to induce neuropathic pain.

Partial sciatic nerve ligation induces long-lasting chronic neuropathic pain, characterized by exaggerated responses to thermal and mechanical stimuli. This mouse model of neuropathic pain is commonly used to study innovative therapies for pain management. This article describes in detail the surgical procedure to improve standardization and reproducibility.

部分坐骨神经结扎术:慢性神经性疼痛的小鼠模型，用于研究新疗法的抗伤害感受作用

Management of chronic pain remains challenging to this day, and current treatments are associated with adverse effects, including tolerance and addiction. ...