Riederer Franz, Penning Sophie, Schoenen Jean
Neurological Center Rosenhuegel and Karl Landsteiner Institute for Clinical Epilepsy Research and Cognitive Neurology, Vienna, Austria.
R&D Department, Cefaly Technology, Liege, Belgium.
Pain Ther. 2015 Oct 14;4(2):135-47. doi: 10.1007/s40122-015-0039-5.
So far, among the different non-invasive neurostimulation methods, only transcutaneous supraorbital nerve stimulation (t-SNS) with the Cefaly (Cefaly Technology sprl, Herstal, Belgium) device has randomized controlled trial-based evidence for safety and efficacy and obtained American Food and Drug Administration approval for the prevention of episodic migraine. In a double-blinded, randomized, sham-controlled trial on 67 episodic migraine patients (mean pre-treatment migraine days/month: 6.9), the 50% responder rate after 3 months was significantly higher in the active group (38.2%) than in the sham group (12.1%); attack frequency and total headache days were also significantly reduced, but not headache severity. Acute anti-migraine drug intake was reduced by 36.7% in the active group. Statistical sub-analysis suggested that t-SNS was more effective in patients with a higher attack frequency. In a large survey on 2313 Cefaly users about safety and satisfaction only 4.3% of subjects reported side effects, all of which were minor and fully reversible, the most frequent being intolerance to the paresthesia feeling and the most severe an allergic skin reaction to the electrode gel. The efficacy/safety ratio of the Cefaly device was therefore most favorable, especially when compared to preventive anti-migraine drugs. The therapeutic efficacy of t-SNS with Cefaly with low-frequency migraine (≤5 attacks/month) was recently confirmed in an open randomized trial. No published data are available in chronic migraine. According to preliminary results of a fluorodeoxyglucose-positron emission tomography study, Cefaly might exert its effect in migraine by increasing activity in crucial areas of the limbic system and salience matrix such as orbitofrontal and anterior cingulate cortices.
到目前为止，在不同的非侵入性神经刺激方法中，只有使用Cefaly（Cefaly Technology sprl，比利时赫斯塔尔）设备的经皮眶上神经刺激（t-SNS）有基于随机对照试验的安全性和有效性证据，并获得了美国食品药品监督管理局预防发作性偏头痛的批准。在一项针对67例发作性偏头痛患者（治疗前平均每月偏头痛天数：6.9）的双盲、随机、假对照试验中，3个月后活性组的50%缓解率（38.2%）显著高于假手术组（12.1%）；发作频率和总头痛天数也显著减少，但头痛严重程度未降低。活性组急性抗偏头痛药物摄入量减少了36.7%。统计亚分析表明，t-SNS对发作频率较高的患者更有效。在一项针对2313名Cefaly使用者的安全性和满意度的大型调查中，只有4.3%的受试者报告有副作用，所有副作用均轻微且完全可逆，最常见的是对感觉异常不耐受，最严重的是对电极凝胶的过敏性皮肤反应。因此，Cefaly设备的疗效/安全性比最为有利，尤其是与预防性抗偏头痛药物相比。最近一项开放随机试验证实了Cefaly的t-SNS对低频偏头痛（每月≤5次发作）的治疗效果。慢性偏头痛方面尚无公开数据。根据一项氟脱氧葡萄糖-正电子发射断层扫描研究的初步结果，Cefaly可能通过增加边缘系统和突显矩阵关键区域（如眶额皮质和前扣带回皮质）的活动来发挥其对偏头痛的作用。
