Effect of opposing needling on motor cortex excitability in healthy participants and in patients with post-stroke hemiplegia: study protocol for a single-blind, randomised controlled trial.
Effect of opposing needling on motor cortex excitability in healthy participants and in patients with post-stroke hemiplegia: study protocol for a single-blind, randomised controlled trial.
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反向针刺对健康参与者和中风后偏瘫患者运动皮层兴奋性的影响：单盲、随机对照试验的研究方案
DOI：
10.1186/s13063-021-05443-x
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发表时间：
2021-07-22
期刊：
影响因子：
2.5
通讯作者：
Wang L
中科院分区：
文献类型：
--
作者：
Xu M;Zi Y;Wu J;Xu N;Lu L;Liu J;Yu Y;Mo H;Wen W;Tang X;Fan W;Zhang Y;Liu C;Yi W;Wang L
对针治疗脑卒中后偏瘫疗效明显；然而，对针治疗脑卒中后偏瘫的机制尚不清楚。本研究旨在探讨反向针刺对健康受试者和脑卒中后偏瘫患者初级运动皮质（M1）兴奋性的影响，为进一步了解反向针刺治疗脑卒中后偏瘫的机制提供依据。这将是一项单盲、随机、假对照试验，将招募80名健康参与者和40名中风后偏瘫患者。健康参与者将按1:1:1:1随机分配到2 hz、50 hz、100 hz和假电针组。卒中后偏瘫患者将按1:1的比例随机分配到相反的针刺组或常规治疗组。M1将通过基于神经成像的导航在所有组中定位。将经颅磁刺激（TMS）的刺激线圈移至左右M1以识别TMS热点，然后记录干预前后经颅磁刺激诱发的大鱼际肌肉静息运动阈值（RMTs）和运动诱发电位（MEPs）。主要结果测量将是基线时和干预后大鱼际肌肉rmt的百分比变化。次要结果测量将是基线和干预后大鱼际肌mep的振幅（μV）和潜伏期（ms）。本试验的目的是探讨反向针刺对健康参与者和中风后偏瘫患者M1兴奋性的影响。中国临床试验注册中心ChiCTR1900028138。2019年12月13日注册在线版本包含补充材料，可在10.1186/s13063-021-05443-x获得。
Opposing needling has an obvious curative effect in the treatment of post-stroke hemiplegia; however, the mechanism of the opposing needling in the treatment of post-stroke hemiplegia is still not clear. The purpose of this study is to investigate the effect of opposing needling on the excitability of primary motor cortex (M1) of healthy participants and patients with post-stroke hemiplegia, which may provide insight into the mechanisms of opposing needling in treating post-stroke hemiplegia. This will be a single-blind, randomised, sham-controlled trial in which 80 healthy participants and 40 patients with post-stroke hemiplegia will be recruited. Healthy participants will be randomised 1:1:1:1 to the 2-Hz, 50-Hz, 100-Hz, and sham electroacupuncture groups. Patients with post-stroke hemiplegia will be randomised 1:1 to the opposing needling or conventional treatment groups. The M1 will be located in all groups by using neuroimaging-based navigation. The stimulator coil of transcranial magnetic stimulation (TMS) will be moved over the left and right M1 in order to identify the TMS hotspot, followed by a recording of resting motor thresholds (RMTs) and motor-evoked potentials (MEPs) of the thenar muscles induced by TMS before and after the intervention. The primary outcome measure will be the percent change in the RMTs of the thenar muscles at baseline and after the intervention. The secondary outcome measures will be the amplitude (μV) and latency (ms) of the MEPs of the thenar muscles at baseline and after the intervention. The aim of this trial is to explore the effect of opposing needling on the excitability of M1 of healthy participants and patients with post-stroke hemiplegia. Chinese Clinical Trial Registry ChiCTR1900028138. Registered on 13 December 2019. The online version contains supplementary material available at 10.1186/s13063-021-05443-x.
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