Abstract
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. Discussion. 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.
Highlights
Stroke is the second leading cause of death, and Kim et al reported that stroke remained the third-leading cause of yearsof-potential-life lost worldwide [1]. e stroke incidence ranged from 76 per 100,000 population per year up to 119 per 100,000 population per year in different countries [2], and it is expected that the incidence of stroke will continue to increase as the population ages [3]. ere are about two million new patients of stroke annually in China [4]
Most of the stroke survivors are Evidence-Based Complementary and Alternative Medicine associated with functional disabilities in China [5], and motor dysfunction is the most significant symptom, which results in different levels of dysfunction and disability in daily life. e stroke impact in China is more severe compared to the worldwide average levels
A total of 20 age, gender, and education-matched healthy subjects will be recruited into the healthy control group. e purpose of healthy control recruitment is to establish a baseline normal magnetic resonance imaging (MRI) data set to facilitate comparison with the MRI data of the patients’ groups. e healthy control group will receive baseline MRI scans without any intervention
Summary
Stroke is the second leading cause of death, and Kim et al reported that stroke remained the third-leading cause of yearsof-potential-life lost worldwide [1]. e stroke incidence ranged from 76 per 100,000 population per year up to 119 per 100,000 population per year in different countries [2], and it is expected that the incidence of stroke will continue to increase as the population ages [3]. ere are about two million new patients of stroke annually in China [4]. On the basis of body acupuncture, temporal three-needle therapy is superior to acupuncture at MS6 with respect to daily life activities [22], motor function [22], and motorrelated sensory disturbances [19]. Rs-fMRI reflects intrinsic functional patterns and the spontaneous activity of the brain’s cortex [23], which is a useful technique for studying the mechanism of acupuncture [24] In this trial, we plan to apply rs-fMRI to explore the central mechanism of temporal three-needle treatment. We hypothesize that the underlying neuroimaging mechanism on neuromodulatory effects in temporal threeneedle acupuncture may be related to sensorimotor network functional connectivity. Our second objective is to explore the relationship between alterations in functional connectivity at the sensorimotor network level and changes in behavioral performances to demonstrate the underlying neuroimaging mechanism of temporal three-needle treatment
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