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间歇性θ波爆发刺激增强慢性卒中患者的上肢运动功能:一项初步随机对照试验。

Intermittent theta burst stimulation enhances upper limb motor function in patients with chronic stroke: a pilot randomized controlled trial.

作者信息

Chen Yu-Jen, Huang Ying-Zu, Chen Chung-Yao, Chen Chia-Ling, Chen Hsieh-Ching, Wu Ching-Yi, Lin Keh-Chung, Chang Tzu-Ling

机构信息

Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital, Linkou, 5, Fushing Street, Kuei-Shan District, Taoyuan City, 33305, Taiwan.

Neuroscience Research Center and Department of Neurology, Chang Gung Memorial Hospital, Linkou, Taiwan.

出版信息

BMC Neurol. 2019 Apr 25;19(1):69. doi: 10.1186/s12883-019-1302-x.

Abstract

BACKGROUND

Intermittent theta burst stimulation (iTBS) is a form of repetitive transcranial stimulation that has been used to enhance upper limb (UL) motor recovery. However, only limited studies have examined its efficacy in patients with chronic stroke and therefore it remains controversial.

METHODS

This was a randomized controlled trial that enrolled patients from a rehabilitation department. Twenty-two patients with first-ever chronic and unilateral cerebral stroke, aged 30-70 years, were randomly assigned to the iTBS or control group. All patients received 1 session per day for 10 days of either iTBS or sham stimulation over the ipsilesional primary motor cortex in addition to conventional neurorehabilitation. Outcome measures were assessed before and immediately after the intervention period: Modified Ashworth Scale (MAS), Fugl-Meyer Assessment Upper Extremity (FMA-UE), Action Research Arm Test (ARAT), Box and Block test (BBT), and Motor Activity Log (MAL). Analysis of covariance was adopted to compare the treatment effects between groups.

RESULTS

The iTBS group had greater improvement in the MAS and FMA than the control group (η = 0.151-0.233; p < 0.05), as well as in the ARAT and BBT (η = 0.161-0.460; p < 0.05) with large effect size. Both groups showed an improvement in the BBT, and there were no significant between-group differences in MAL changes.

CONCLUSIONS

The iTBS induced greater gains in spasticity decrease and UL function improvement, especially in fine motor function, than sham TBS. This is a promising finding because patients with chronic stroke have a relatively low potential for fine motor function recovery. Overall, iTBS may be a beneficial adjunct therapy to neurorehabilitation for enhancing UL function. Further larger-scale study is warranted to confirm the findings and its long-term effect.

TRIAL REGISTRATION

This trial was registered under ClinicalTrials.gov ID No. NCT01947413 on September 20, 2013.

摘要

背景

间歇性θ波爆发刺激(iTBS)是一种重复经颅刺激形式,已被用于促进上肢(UL)运动功能恢复。然而,仅有有限的研究考察了其对慢性卒中患者的疗效,因此其疗效仍存在争议。

方法

这是一项随机对照试验,研究对象来自康复科。22例首次发生慢性单侧脑卒中年龄在30至70岁之间的患者被随机分配至iTBS组或对照组。所有患者除接受常规神经康复治疗外,在患侧初级运动皮层接受iTBS或假刺激,每天1次,共10天。在干预期前后评估结果指标:改良Ashworth量表(MAS)、Fugl-Meyer上肢评估量表(FMA-UE)、动作研究臂测试(ARAT)、箱块测试(BBT)和运动活动日志(MAL)。采用协方差分析比较组间治疗效果。

结果

iTBS组在MAS和FMA方面的改善程度大于对照组(η=0.151-0.233;p<0.05),在ARAT和BBT方面也是如此(η=0.161-0.460;p<0.05),效应量较大。两组在BBT方面均有改善,且在MAL变化方面组间无显著差异。

结论

与假刺激相比,iTBS在降低痉挛和改善上肢功能,尤其是精细运动功能方面取得了更大进展。这是一个有前景的发现,因为慢性卒中患者精细运动功能恢复潜力相对较低。总体而言,iTBS可能是神经康复治疗中增强上肢功能的有益辅助治疗方法。需要进一步开展更大规模的研究来证实这些发现及其长期效果。

试验注册

本试验于2013年9月20日在ClinicalTrials.gov注册,注册号为NCT01947413。

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