Li Minying, Wang Lin, Xu Nenggui, Tang Xiaorong, Xu Mindong, Liu Jianhua, Huang Jianpeng, Schlaeger Judith M
South China Research Center for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, 510006, China.
Traditional Chinese Medicine Hospital of Guangdong Province, Guangzhou, 510000, China.
Trials. 2019 Mar 21;20(1):180. doi: 10.1186/s13063-019-3267-x.
Numerous randomized controlled trials on the effects of electro-acupuncture have been conducted to treat dysphagia as a sequela of stroke. However, the normal physiological mechanisms of swallowing and the pathological mechanisms of dysphagia are not fully understood. The purpose of this study is to investigate whether lateralization of the human swallowing motor cortex excitability in healthy subjects will be influenced by electro-acupuncture to Lianquan (CV 23) and Fengfu (GV 16), which may provide insight into the pathological mechanisms of dysphagia after stroke.
We designed a single-blind, randomized, sham-controlled trial in which 40 healthy subjects will be recruited. Subjects will be randomized 1:1 into two groups: the electro-acupuncture group and the sham-control electro-acupuncture group. The swallowing motor cortex will be located in both groups using a neuroimaging navigation system. Then left and right cortical stimulation will be measured by transcranial magnetic stimulation (TMS) before and after electro-acupuncture or sham electro-acupuncture. The electro-acupuncture or sham electro-acupuncture interventions will last for 15 min. The primary outcome measure will be percent change in the resting motor threshold (RMT) of the mylohyoid. The secondary outcome measures will be the amplitude (μV) and latency (ms) of the motor evoked potential (MEP) of the mylohyoid as a proxy for the TMS evoked potential. All outcomes will be measured at baseline and after the electro-acupuncture or sham electro-acupuncture treatment.
The aim of this trial is to explore whether lateralization of the human swallowing motor cortex excitability in healthy subjects is present, and to determine if electro-acupuncture to acupuncture points Lianquan (CV 23) and Fengfu (GV 16) will exert an effect on it under normal physiological conditions.
Chinese Clinical Trial Registry, ChiCTR-IOR-17011359 . Registered on 11 May 2017.
已经开展了许多关于电针治疗中风后遗症吞咽困难效果的随机对照试验。然而，吞咽的正常生理机制和吞咽困难的病理机制尚未完全明确。本研究的目的是调查电针廉泉（CV 23）和风府（GV 16）是否会影响健康受试者吞咽运动皮层兴奋性的偏侧化，这可能有助于深入了解中风后吞咽困难的病理机制。
我们设计了一项单盲、随机、假对照试验，将招募40名健康受试者。受试者将按1:1随机分为两组：电针组和假对照电针组。两组均使用神经影像导航系统定位吞咽运动皮层。然后在电针或假电针前后，通过经颅磁刺激（TMS）测量左右皮质刺激。电针或假电针干预将持续15分钟。主要结局指标将是下颌舌骨肌静息运动阈值（RMT）的变化百分比。次要结局指标将是下颌舌骨肌运动诱发电位（MEP）的波幅（μV）和潜伏期（ms），作为TMS诱发电位的替代指标。所有结局指标将在基线以及电针或假电针治疗后进行测量。
本试验的目的是探讨健康受试者是否存在吞咽运动皮层兴奋性的偏侧化，并确定在正常生理条件下，电针廉泉穴（CV 23）和风府穴（GV 16）是否会对其产生影响。
中国临床试验注册中心，ChiCTR-IOR-17011359。于2017年5月11日注册。
