Background Low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1) has demonstrated beneficial effects on motor recovery, but evidence among patients with subacute stroke is lacking. We aimed to investigate whether 1-Hz rTMS over the contralesional M1 versus sham rTMS could improve arm function in patients with subacute ischemic stroke when combined with rehabilitative motor training. Methods In total, 77 patients who were within 90 days after their first-ever ischemic stroke were enrolled and randomly allocated to either real (n = 40) or sham rTMS (n = 37). We delivered 1-Hz 30-minute active or sham rTMS before each daily 30-minute occupational therapy sessions over a 2-week period. The primary endpoint was changes in the Box and Block Test (BBT) score immediately after the end of treatment (EOT). Secondary analyses assessed changes in Fugl-Meyer assessment, Finger Tapping Test (FTT), Brunnstrom stage, and grip strength. Clinical Trial Registration ClinialTrials.gov (NCT02082015). Results Changes in BBT immediately after the end of treatment did not differ significantly between the 2 groups (P = .267). Subgroup analysis according to cortical involvement revealed that real rTMS resulted in improvements in BBT at 1 month after EOT (17.4 ± 9.8 real vs 10.9 ± 10.3 sham; P = .023) and Brunnstrom stage of the hand immediately after EOT (0.6 ± 0.5 real vs 0.2 ± 0.5 sham; P = .023), only in the group without cortical involvement. Conclusion The effects of real and sham rTMS did not differ significantly among patients within 3 months poststroke. The location of stroke lesions should be considered for future clinical trials.

中文翻译：

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对侧运动皮层的低频重复经颅磁刺激用于亚急性缺血性卒中的运动恢复：一项随机假手术对照试验

背景 对侧运动皮层 (M1) 的低频重复经颅磁刺激 (rTMS) 已证明对运动恢复有益，但缺乏亚急性中风患者的证据。我们的目的是研究 1-Hz rTMS 与对侧 M1 对比假 rTMS 是否可以在结合康复运动训练时改善亚急性缺血性卒中患者的手臂功能。方法 总共有 77 名在首次缺血性卒中发生后 90 天内的患者被纳入并随机分配到真实（n = 40）或假 rTMS（n = 37）。在 2 周的时间内，我们在每天 30 分钟的职业治疗课程之前提供 1-Hz 30 分钟的主动或假 rTMS。主要终点是治疗结束 (EOT) 后立即发生的 Box and Block Test (BBT) 评分的变化。二次分析评估了 Fugl-Meyer 评估、手指敲击测试 (FTT)、Brunnstrom 阶段和握力的变化。临床试验注册 ClinialTrials.gov (NCT02082015)。结果 治疗结束后立即 BBT 的变化在 2 组之间没有显着差异 (P = .267)。根据皮质受累的亚组分析显示，真正的 rTMS 导致 EOT 后 1 个月的 BBT 改善（17.4 ± 9.8 real vs 10.9 ± 10.3 sham；P = .023）和 EOT 后立即手的 Brunnstrom 阶段（0.6 ± 0.5 real与 0.2 ± 0.5 假手术；P = .023），仅在没有皮质受累的组中。结论 真实和假 rTMS 的影响在卒中后 3 个月内在患者中没有显着差异。在未来的临床试验中应考虑卒中病变的位置。