Department of Neurosurgery, University Hospital Heidelberg, Heidelberg, Germany.
Division of Surgical Pain Management, Department of Neurosurgery, University Hospital Heidelberg, Heidelberg, Germany.
Neuromodulation. 2021 Aug;24(6):1115-1120. doi: 10.1111/ner.13478. Epub 2021 Jul 27.
Subcutaneous trigeminal nerve field stimulation (sTNFS) is a neuromodulatory treatment for neuropathic trigeminal pain with the ability to reduce the intensity and frequency of pain attacks. However, hardware issues including lead migration, skin erosion, infection, so-called pocket pain at the site of the implanted neurostimulator are reported. Implantable wireless neurostimulation technology promises not only an even less invasive sTNFS treatment and thinner and more flexible electrodes better suited for facial implants, but also provides further advantages such as lack of an implantable neurostimulator and 3T magnetic resonance imaging compatibility.
All patients who had received trial stimulation with a partially implantable sTNFS system were analyzed for ICHD-3 (3rd edition of the International Classification of Headache Disorders) diagnosis, success of trial stimulation, pre- and postoperative pain intensity, frequency of attacks, complications, and side-effects of sTNFS.
All patients (N = 3) responded to sTNFS (≥50% pain reduction) during the trial period. According to ICHD-3, N = 2 of the patients were classified with trigeminal neuralgia (TN) with concomitant persistent facial pain and N = 1 patient with multiple sclerosis associated TN. The time of the test period was 44 ± 31.24 days (mean ± SD). The average daily duration of stimulation per patient amounted 2.5 ± 2.2 hours (range 1-5). The pain intensity (defined on a visual analog scale) was reduced by 80% ± 17% (mean ± SD). Reduction or cessation in pain medication was observed in all patients. No surgical complications occurred in the long-term follow-up period of 18.84 ± 6 (mean ± SD) months.
The partially implantable sTNFS device seems to be safe, effective, and reliable. Compared to conventional devices, the equipment is not limited to the length of trial stimulation. Furthermore, the daily stimulation duration was much shorter compared to previous reports.
皮下三叉神经场刺激（sTNFS）是一种治疗三叉神经病理性疼痛的神经调节治疗方法，具有降低疼痛发作强度和频率的能力。然而，硬件问题包括导联迁移、皮肤侵蚀、感染、植入神经刺激器部位所谓的“口袋痛”等问题时有报道。可植入式无线神经刺激技术不仅承诺提供更微创的 sTNFS 治疗，更薄、更灵活的电极更适合面部植入，而且还提供了进一步的优势，如无需植入式神经刺激器和 3T 磁共振成像兼容性。
所有接受部分可植入 sTNFS 系统试验刺激的患者均根据 ICHD-3（国际头痛疾病分类第 3 版）诊断、试验刺激的成功、术前和术后疼痛强度、发作频率、并发症以及 sTNFS 的副作用进行分析。
所有患者（N=3）在试验期间均对 sTNFS 有反应（疼痛减轻≥50%）。根据 ICHD-3，N=2 例患者被归类为三叉神经痛（TN）伴持续性面部疼痛，N=1 例患者为多发性硬化相关 TN。试验期时间为 44±31.24 天（均值±标准差）。每位患者的平均每日刺激时间为 2.5±2.2 小时（范围 1-5）。疼痛强度（定义为视觉模拟评分）降低了 80%±17%（均值±标准差）。所有患者均减少或停止使用止痛药物。在 18.84±6 个月（均值±标准差）的长期随访中未发生手术并发症。
部分可植入 sTNFS 装置似乎安全、有效且可靠。与传统设备相比，该设备不受试验刺激时间的限制。此外，与之前的报告相比，每日刺激时间要短得多。
