Pain & Neuromodulation Academic Research Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.
Nevro Corp, Redwood City, CA, USA.
Neuromodulation. 2022 Jan;25(1):103-113. doi: 10.1111/ner.13465.
Refractory chronic migraine (rCM) is a highly disabling condition for which novel safe and effective treatments are needed. Safety and long-term efficacy of paresthesia-free high cervical 10 kHz spinal cord stimulation (SCS) were here prospectively evaluated for the treatment of rCM.
Twenty adults with rCM (mean numbers of preventive treatments failed: 12.2 ± 3.1) were enrolled in this single-center, open-label, prospective study and implanted with a 10 kHz SCS system (Senza™ system, Nevro Corp), with the distal tip of the lead(s) positioned epidurally at the C2 vertebral level. Safety and effectiveness outcomes, such as adverse events, headache and migraine reductions, responder rates, Migraine Disability Assessment (MIDAS), Headache Impact Test-6 (HIT-6), and Migraine-Specific Quality-of-Life (MSQ), were captured up to 52 weeks after implantation.
Compared to baseline, at 52 weeks postimplantation, there was a significant reduction of mean monthly migraine days (MMD) by 9.3 days (p < 0.001). Sixty percent and 50% of patients obtained respectively at least 30% and at least 50% reduction in mean MMD. By week 52, 50% of patients' chronic pattern converted to an episodic pattern. The proportion of subjects classified with severe headache-related disability on the HIT-6, decreased from 100% to 60% at week 52. Meaningful improvements of headache-related quality of life measured by the MSQ scale were observed with mean gain of 24.9 ± 23.1 (p < 0.001) points at 52 weeks. No unanticipated adverse device effects occurred. No patients required any additional device surgical revision.
10 kHz SCS may a be safe and effective neurostimulation option for rCM patients. The paresthesia-free waveform constitutes an unprecedented advantage for future methodologically sound sham-controlled studies in headache neuromodulation.
难治性慢性偏头痛（rCM）是一种高度致残的疾病，需要新的安全有效的治疗方法。本研究前瞻性评估了无刺痛感的高颈段 10 kHz 脊髓刺激（SCS）治疗 rCM 的安全性和长期疗效。
20 名 rCM 成人（预防性治疗失败的平均次数：12.2±3.1）参与了这项单中心、开放标签、前瞻性研究，并植入了 10 kHz SCS 系统（Senza™系统，Nevro 公司），将导线的远端尖端置于 C2 椎体水平的硬膜外。安全性和有效性结果，如不良事件、头痛和偏头痛减少、应答率、偏头痛残疾评估（MIDAS）、头痛影响测试-6（HIT-6）和偏头痛特异性生活质量（MSQ），在植入后 52 周内进行了评估。
与基线相比，植入后 52 周时，平均每月偏头痛天数（MMD）显著减少 9.3 天（p<0.001）。60%和 50%的患者分别获得了至少 30%和至少 50%的 MMD 减少。到第 52 周时，50%的患者的慢性模式转变为发作性模式。在 HIT-6 上，头痛相关残疾严重程度分类的受试者比例从 100%下降到 60%。在第 52 周时，通过 MSQ 量表测量的与头痛相关的生活质量有了显著改善，平均提高了 24.9±23.1 分（p<0.001）。没有发生意外的不良设备相关影响。没有患者需要进行任何额外的设备手术修正。
10 kHz SCS 可能是 rCM 患者的一种安全有效的神经刺激选择。无刺痛感的波形为未来头痛神经调节的方法学上合理的假刺激对照研究提供了前所未有的优势。
