NEUROMODULATION:10kHz脊髓刺激治疗难治性慢性偏头痛的安全性和有效性:一项前瞻性长期开放标记研究

2021-06-14 MedSci原创 MedSci原创

慢性偏头痛(CM)被认为是一种严重的偏头痛,影响1.4-2.2%的 人群,发作性偏头痛(EM)人群的年发病率为2.5%。 极少数的CM患者对治疗产生了耐药性。 枕神经刺激(ONS)被选为是rCM的首选

慢性偏头痛(CM)被认为是一种严重的偏头痛,影响1.4-2.2%的 人群,发作性偏头痛(EM)人群的年发病率为2.5%。 极少数的CM患者对治疗产生了耐药性。 枕神经刺激(ONS)被选为是rCM的首选治疗方法已有一段时间了。当在随机临床试验中进行研究时,其益处并没有期望的那么显著 。 在开放性研究中,以高颈背柱为靶点的神经刺激已成为rCM中一种新的潜在可行和安全的治疗方法 。

10 kHz的脊髓刺激(SCS)是一种微创的神经刺激疗法,是一种对各种慢性疼痛综合征患者有前景的治疗方法。 10 kHz SCS的确切作用机制尚未完全阐明。最近的临床前研究表明,由于背角抑制性中间神经元的激活,在低于感觉阈值的强度下,背角的疼痛感觉处理可能减少。本研究的目的是评估在无药物使用的情况下将10kHz SCS输送至高位颈髓的安全性和长期有效性。

这是一项前瞻性、单中心、开放性研究,旨在评估颈部10kHz SCS治疗rCM的安全性和有效性。符合条件的参与者是18-65岁的成年人,他们符合经修订的第二版国际头痛病分类(ICHD-2R)CM诊断标准,并且在筛查时对药物治疗无效。合格受试者植入10 kHz SCS系统。手术是在全身麻醉下进行的。头痛病历中记录了头痛特征,包括每日头痛强度、头痛持续时间、相关症状的出现。与基线相比,12周时MHD平均减少的天数为3.6 ± 7.2 天(p=0.039),24周 是2.8 ± 5.3天(p=0.021), 52周是5.3  ± 7.4 天(p=0.004)。与基线相比,12周时MMD的平均减少 为6.7 ± 9.9(p=0.007),  24周是5.0 ± 8.1(p=0.011),  52周减少9.3 ± 9.3 天(p < 0.001) 。

image

受试者流程图

通过MIDAS和HIT-6量表测量,头痛在整个研究过程中得到改善。在这两个量表上,所有参与者在基线时都被归类为重度疼痛。在52周时收集的GIC调查问卷上 两周后,75%的受试者被医生评定为较好改善,70%的受试者对他们的治疗“非常满意”或“满意”,85%的受试者表示他们将推荐他们的治疗。

image

中度至重度头痛日数和偏头痛日数

研究结果提示,10khz的脊髓电刺激可能是rCM的一个长期有效的治疗选择。在一年的随访中,平均MMD频率下降了9.3% 天。10 kHz-SCS已显示出对各种慢性疼痛综合征患者的干预作用。14个rCM和 植入高颈段10kHz SCS刺激器的受试者,50%的受试者在6个月时头痛频率分别减少>30%。但SCS的相关并发症发生率令人担忧。铅迁移是最常见的并发症,占16.7%。

总之,高颈段10khzscs可能是rCM患者的一种新兴治疗方式。 该疗法可能是一种安全、有效和耐受性良好的治疗方法。

Al-Kaisy, A., Palmisani, S., Carganillo, R., Wesley, S., Pang, D., Rotte, A., Santos, A. and Lambru, G. (2021), Safety and Efficacy of 10 kHz Spinal Cord Stimulation for the Treatment of Refractory Chronic Migraine: A Prospective Long-Term Open-Label Study. Neuromodulation: Technology at the Neural Interface.

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    2023-05-06 侠胆医心 来自上海

    10kHz#脊髓刺激#治疗难治性慢性#偏头痛#的安全性和有效性

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    2021-06-16 freve
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    2021-06-14 124794a3m20(暂无昵称)

    学习。

    0

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    2021-06-14 ms7000002130458668

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