Cortical stimulation for upper limb recovery following ischemic stroke: A small phase II pilot study of a fully implanted stimulator
Cortical stimulation for upper limb recovery following ischemic stroke: A small phase II pilot study of a fully implanted stimulator
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DOI：
10.1310/tsr1502-160
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发表时间：
2008-03-01
影响因子：
2.2
通讯作者：
Levy, Robert
中科院分区：
文献类型：
--
作者：
Huang, Mark;Harvey, Richard L.;Levy, Robert
目的：评价全植入皮质刺激器改善缺血性脑卒中患者手、臂功能的可行性。方法：将24例慢性脑卒中偏瘫患者随机分为两组，一组采用定向植入皮质电刺激，另一组采用上肢康复治疗，另一组单独采用康复治疗。结果：使用重复测量回归模型，我们估计并比较了研究随访期间各组之间的治疗效果。与对照组相比，研究组在6个月的随访期间（治疗后第1-24周）上肢Fugl-Meyer （UEFM）评分的平均改善显著更大（估计平均值差异= 3.8,p = 0.042）。在6个月的随访评估中，试验组的Box和Block （B & B）测试较基线得分的改善也显著更好（估计平均值差异= 3.8,p = 0.046）。在植入装置后但在皮质刺激和康复治疗之前，有一例癫痫发作的报告，但没有神经功能下降的报告。在评估的其他措施中没有看到任何改善。结论：有证据表明，皮质刺激结合康复治疗对上肢运动控制具有持久的治疗效果，且与严重的神经系统并发症无关。一个更大的多中心研究正在进行中。
Objective: To evaluate the feasibility of a fully implanted cortical stimulator for improving hand and arm function inpatients following ischemic stroke. Method: Twenty-four chronic stroke patients with hemiplegia were randomized to targeted implanted cortical electrical stimulation of the motor cortex with upper limb rehabilitation therapy or rehabilitation therapy alone. Results: Using repeated measures regression models, we estimated and compared treatment effects between groups over the study follow-up period. The investigational group had significantly greater mean improvements in Upper Extremity Fugl-Meyer (UEFM) scores during the 6-month follow-up period (weeks 1-24 following therapy), as compared to the control group (difference in estimated means = 3.8, p = .042). Box and Block (B & B) test improvement from baseline scores were also significantly better in the investigational group across the 6-month follow-up assessments (difference in estimated means = 3.8, p = .046). There was one report of seizure after device implant but prior to cortical stimulation and rehabilitation therapy, but no reports of neurologic decline. There were no improvements seen in the other measures assessed. Conclusion: Evidence suggests that cortical stimulation with rehabilitation therapy produces a lasting treatment effect in upper extremity motor control and is not associated with serious neurological complications. A larger multicenter study is underway.