Trentman Terrence L, Rosenfeld David M, Vargas Bert B, Schwedt Todd J, Zimmerman Richard S, Dodick David W
Department of Anesthesiology, Mayo Clinic Arizona, Scottsdale, AZ 85054, USA.
Pain Physician. 2009 May-Jun;12(3):621-8.
Millions of patients suffer from medically refractory and disabling primary headache disorders. This problem has led to a search for new and innovative treatment modalities, including neuromodulation of the occipital nerves.
The primary aim of this study is to describe an implantation technique for the Bion microstimulator and document stimulation parameters and stimulation maps after Bion placement adjacent to the greater occipital nerve. The secondary aim is to document outcome measures one year post-implant.
Prospective, observational feasibility study.
Nine patients with medically refractory primary headache disorders participated in this study. Approximately 6 months after Bion insertion, stimulation parameters and maps were documented for all patients. At one year, outcome measures were collected including the Migraine Disability Assessment Score.
At 6 months, the mean perception threshold was 0.47 mA, while the mean discomfort threshold was 6.8 mA (stimulation range 0.47-6.8 mA). The mean paresthesia threshold was 1.64 mA and the mean usage range was 16.0. There were no major complications reported such as device migration, infection, or erosion. One patient stopped using her Bion before the 12-month follow-up visit. At one year, 7 of the 8 patients were judged as having obtained fair or better results in terms of reduction of disability; 5 patients had greater than a 90% reduction in disability.
Small, heterogeneous patient population without control group. Not blinded or randomized.
The Bion can be successfully inserted adjacent to the greater occipital nerve in an effort to treat refractory primary headache disorders. This microstimulator may provide effective occipital stimulation and headache control while minimizing the risks associated with percutaneous or paddle leads implanted subcutaneously in the occipital region.
数百万患者患有药物难治性且致残的原发性头痛疾病。这一问题促使人们寻找新的创新治疗方式，包括枕神经的神经调节。
本研究的主要目的是描述Bion微刺激器的植入技术，并记录在将Bion放置于枕大神经附近后的刺激参数和刺激图谱。次要目的是记录植入后一年的疗效指标。
前瞻性观察性可行性研究。
9例患有药物难治性原发性头痛疾病的患者参与了本研究。在插入Bion约6个月后，记录所有患者的刺激参数和图谱。在一年时，收集疗效指标，包括偏头痛残疾评估评分。
在6个月时，平均感知阈值为0.47毫安，而平均不适阈值为6.8毫安（刺激范围0.47 - 6.8毫安）。平均感觉异常阈值为1.64毫安，平均使用范围为16.0。未报告重大并发症，如设备移位、感染或侵蚀。1例患者在12个月随访前停止使用其Bion。在一年时，8例患者中有7例在残疾减轻方面被判定取得了中等或更好的结果；5例患者的残疾减轻超过90%。
患者群体小且异质性大，无对照组。非盲法且未随机分组。
为治疗难治性原发性头痛疾病，可成功地将Bion插入枕大神经附近。这种微刺激器可提供有效的枕部刺激并控制头痛，同时将与经皮或皮下植入枕部区域的片状电极相关的风险降至最低。
