Zhao Ning, Zhang Hong, Liu Tongyan, Liu Jiao, Xiang Yun, Shu Guojian, Li Chunzhen, Xie Jingwen, Chen Lidian
Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China.
The 6th Affiliated Hospital of Shenzhen University Health Science Center, Shenzhen Nanshan District People's Hospital, Shenzhen 518052, China.
Evid Based Complement Alternat Med. 2021 Jan 4;2021:8820324. doi: 10.1155/2021/8820324. eCollection 2021.
BACKGROUND: The clinical efficacy of temporal three-needle therapy for stroke dysfunction has been previously demonstrated in China. However, the central mechanism of temporal three-needle therapy remains unclear. Temporal three-needle projects the sensory cortex and the motor cortex, which may impact the cortex function. Current studies seldom focus on it. Hence, according to the "scalp-cortex corresponding theory," the underlying mechanism of temporal three-needle remains a domain for further research. METHODS: This trial is designed to provide objective and visual evidence for the neuromodulatory effect and neuroimaging mechanism of temporal three-needle therapy for stroke patients. This ongoing study is a prospective, randomized, controlled, patient-assessor blind, single-center, neuroimaging trial involving two-parallel patient groups and a healthy control group. Forty eligible patients will be recruited from Shenzhen Nanshan District People's Hospital and randomized into either the experimental group or the control group. Twenty healthy volunteers will be recruited in the healthy control group and undergo baseline magnetic resonance imaging scans without any intervention. Patients in the control group will receive acupuncture at Dingnieqianxiexian (MS6), in addition to basic medicine and rehabilitative treatments. Patients in the experimental group will receive temporal three-needle therapy plus basic medicine and rehabilitative treatments 5 days per week, 10 sessions over two consecutive weeks. The primary outcome is resting-state functional connectivity, and the secondary outcomes are regional homogeneity, amplitude of low-frequency fluctuations, Fugl-Meyer assessment of the upper limb, and modified Barthel Index. All outcome measures will be assessed at baseline and after 2 weeks of intervention. . The results will explore the neuromodulatory effects and illustrate the central mechanism of temporal three-needle treatment from the network-level viewpoint of sensorimotor network functional plasticity and promote widespread application in real-world practice. This trial was registered at Chinese Clinical Trial Registry on 14 March 2018 with ChiCTR1800015209.
背景:颞三针疗法治疗中风功能障碍的临床疗效此前已在中国得到证实。然而,颞三针疗法的中枢机制仍不清楚。颞三针投射至感觉皮层和运动皮层,这可能会影响皮层功能。目前的研究很少关注这一点。因此,根据“头皮-皮层对应理论”,颞三针的潜在机制仍是一个有待进一步研究的领域。 方法:本试验旨在为颞三针疗法对中风患者的神经调节作用和神经影像学机制提供客观、可视化的证据。这项正在进行的研究是一项前瞻性、随机、对照、患者-评估者双盲、单中心、神经影像学试验,涉及两个平行的患者组和一个健康对照组。将从深圳市南山区人民医院招募40名符合条件的患者,并随机分为试验组或对照组。健康对照组将招募20名健康志愿者,在不进行任何干预的情况下接受基线磁共振成像扫描。对照组患者除接受基础药物治疗和康复治疗外,还将针刺定颞前线(MS6)。试验组患者将接受颞三针疗法,每周5天,连续两周共10次,同时接受基础药物治疗和康复治疗。主要结局是静息态功能连接,次要结局是局部一致性、低频振幅、上肢Fugl-Meyer评估和改良Barthel指数。所有结局指标将在基线和干预2周后进行评估。结果将探索神经调节作用,并从感觉运动网络功能可塑性的网络层面观点阐明颞三针治疗的中枢机制,促进其在实际临床中的广泛应用。本试验于2018年3月14日在中国临床试验注册中心注册,注册号为ChiCTR1800015209。
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