Multifocal transcranial stimulation in chronic ischemic stroke: A phase 1/2a randomized trial
Multifocal transcranial stimulation in chronic ischemic stroke: A phase 1/2a randomized trial
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DOI：
10.1016/j.jstrokecerebrovasdis.2020.104816
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发表时间：
2020-06-01
影响因子：
2.5
通讯作者：
Helekar, Santosh A.
中科院分区：
文献类型：
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作者：
Chiu, David;McCane, C. David;Helekar, Santosh A.
背景和目的：重复经颅磁刺激（rTMS）可能通过诱导脑皮层回路的功能重组促进脑卒中后运动功能的恢复。本研究的目的是检查使用新型可穿戴经颅旋转永磁刺激器（TRPMS）的多焦皮层刺激是否可以通过诱导皮层回路的功能重组来促进卒中后运动功能的恢复。研究方法：330例慢性缺血性卒中和稳定性单侧无力患者入组1/2a期随机双盲假对照临床试验，以评估安全性和初步疗效。双侧半球刺激，共20个会议，每40分钟，超过4周。主要疗效终点为治疗结束后即刻功能性MRI BOLD激活的变化。次要疗效终点为运动功能临床量表，包括Fugl-Meyer运动臂评分、ARAT、握力、捏力、步态速度和NIHSS。结果：TRPMS治疗耐受性良好，无器械相关不良反应。与假手术组相比，活性治疗组在fMRI上的活性体素数量显著增加（中位数+48.5 vs-30，p = 0.038）。活性治疗后的中位活性体素数量是假手术后的8.8倍（227.5 vs 26，p = 0.016）。尽管统计功效不足以确定临床终点获益，但在6个运动功能临床量表中的5个中证实了数值改善。治疗效果持续3个月的随访。结论：多焦双侧TRPMS是安全的，并显示出显着的功能磁共振成像的变化，提示慢性缺血性卒中患者的皮层电路的功能重组。需要进行更大规模的随机临床试验来验证运动功能的恢复。
Background and Purpose: Repetitive transcranial magnetic stimulation (rTMS) may promote recovery of motor function after stroke by inducing functional reorganiza-tion of cortical circuits. The objective of this study was to examine whether multifo-cal cortical stimulation using a new wearable transcranial rotating permanent magnet stimulator (TRPMS) can promote recovery of motor function after stroke by inducing functional reorganization of cortical circuits. Methods: Thirty30 patients with chronic ischemic stroke and stable unilateral weakness were enrolled in a Phase 1/2a randomized double-blind sham-controlled clinical trial to evaluate safety and preliminary efficacy. Bilateral hemispheric stimulation was administered for 20 sessions 40 min each over 4 weeks. The primary efficacy endpoint was the change in functional MRI BOLD activation immediately after end of treatment. Sec-ondary efficacy endpoints were clinical scales of motor function, including the Fugl-Meyer motor arm score, ARAT, grip strength, pinch strength, gait velocity, and NIHSS. Results: TRPMS treatment was well-tolerated with no device-related adverse effects. Active treatment produced a significantly greater increase in the number of active voxels on fMRI than sham treatment (median +48.5 vs-30, p = 0.038). The median active voxel number after active treatment was 8.8-fold greater than after sham (227.5 vs 26, p = 0.016). Although the statistical power was inadequate to establish clinical endpoint benefits, numerical improvements were demonstrated in 5 of 6 clinical scales of motor function. The treatment effects per -sisted over a 3-month duration of follow-up. Conclusions: Multifocal bilateral TRPMS was safe and showed significant fMRI changes suggestive of functional reorganization of cortical circuits in patients with chronic ischemic stroke. A larger randomized clinical trial is warranted to verify recovery of motor function.