The Shirley Ryan AbilityLab, Northwestern University Feinberg School of Medicine, Chiago, IL (R.L.H., L.M.R.).
Burke Neurological Institute, Weill Cornell Neurology, White Plains, NY (D.E.).
Stroke. 2018 Sep;49(9):2138-2146. doi: 10.1161/STROKEAHA.117.020607.
Background and Purpose- We aimed to determine whether low-frequency electric field navigated repetitive transcranial magnetic stimulation to noninjured motor cortex versus sham repetitive transcranial magnetic stimulation avoiding motor cortex could improve arm motor function in hemiplegic stroke patients when combined with motor training. Methods- Twelve outpatient US rehabilitation centers enrolled participants between May 2014 and December 2015. We delivered 1 Hz active or sham repetitive transcranial magnetic stimulation to noninjured motor cortex before each of eighteen 60-minute therapy sessions over a 6-week period, with outcomes measured at 1 week and 1, 3, and 6 months after end of treatment. The primary end point was the percentage of participants improving ≥5 points on upper extremity Fugl-Meyer score 6 months after end of treatment. Secondary analyses assessed changes on the upper extremity Fugl-Meyer and Action Research Arm Test and Wolf Motor Function Test and safety. Results- Of 199 participants, 167 completed treatment and follow-up because of early discontinuation of data collection. Upper extremity Fugl-Meyer gains were significant for experimental ( P<0.001) and sham groups ( P<0.001). Sixty-seven percent of the experimental group (95% CI, 58%-75%) and 65% of sham group (95% CI, 52%-76%) improved ≥5 points on 6-month upper extremity Fugl-Meyer ( P=0.76). There was also no difference between experimental and sham groups in the Action Research Arm Test ( P=0.80) or the Wolf Motor Function Test ( P=0.55). A total of 26 serious adverse events occurred in 18 participants, with none related to the study or device, and with no difference between groups. Conclusions- Among patients 3 to 12 months poststroke, goal-oriented motor rehabilitation improved motor function 6 months after end of treatment. There was no difference between the active and sham repetitive transcranial magnetic stimulation trial arms. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02089464.
背景与目的-我们旨在确定在结合运动训练的情况下，非损伤性运动皮层的低频电场导航重复经颅磁刺激与避开运动皮层的假重复经颅磁刺激相比，是否可以改善偏瘫中风患者的手臂运动功能。方法-12 家美国门诊康复中心于 2014 年 5 月至 2015 年 12 月期间招募参与者。在 6 周期间的 18 次 60 分钟治疗过程中，我们在每次治疗前给予 1Hz 的活性或假重复经颅磁刺激，在治疗结束后 1 周、1、3 和 6 个月测量结果。主要终点是治疗结束后 6 个月时，上肢 Fugl-Meyer 评分提高≥5 分的参与者比例。次要分析评估了上肢 Fugl-Meyer 和动作研究臂测试和 Wolf 运动功能测试的变化以及安全性。结果-在 199 名参与者中，由于数据收集提前中断，有 167 名参与者完成了治疗和随访。实验组（P<0.001）和假组（P<0.001）的上肢 Fugl-Meyer 增益均有显著意义。实验组的 67%（95%CI，58%-75%）和假组的 65%（95%CI，52%-76%）在 6 个月时上肢 Fugl-Meyer 评分提高≥5 分（P=0.76）。实验组和假组在动作研究臂测试（P=0.80）或 Wolf 运动功能测试（P=0.55）之间也没有差异。18 名参与者中共有 26 例严重不良事件发生，均与研究或设备无关，且两组之间无差异。结论-在中风后 3 至 12 个月的患者中，以目标为导向的运动康复可改善治疗结束后 6 个月的运动功能。实验组和假组之间没有差异。临床试验注册-网址：https://www.clinicaltrials.gov。唯一标识符：NCT02089464。
