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静息态fMRI显示taVNS通过重构“感觉中继-突显-默认”跨网络有效连接改善轻度认知障碍的认知与情绪功能:随机双盲假对照试验

Rs-fMRI reveals that taVNS improves cognitive and emotional function in mild cognitive impairment by reconfiguration of "sensory relay-salience-default" cross-network effective connectivity: a randomized, double-blind, sham-controlled trial

Front Neurol · 2026 年 8 月 12 日 · Tianjiao Xu, Chunlei Guo, Lei Zhang 等 9 人

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耳迷走神经刺激改善轻度认知障碍并重塑脑网络连接

轻度认知障碍是痴呆前阶段,经皮耳迷走神经刺激(taVNS,通过耳部电极刺激迷走神经分支的无创方法)被视为有前景的干预,但其疗效和脑网络机制不清。本随机双盲假对照试验纳入60名患者,1:1接受12周真或假taVNS,主要终点为MoCA-B(蒙特利尔认知评估基础版)评分变化。结果显示真刺激组认知与多项次要指标改善,组间MoCA-B差值2.91分(95% CI 0.79–5.03),效应量中等偏大,且有效连接在以岛叶、前扣带等为核心的网络内被选择性重构,无严重不良事件。该研究为taVNS改善认知提供了网络层面的机制证据。

为什么推荐给您:设计严谨的随机双盲试验,首次用有效连接刻画taVNS改善轻度认知障碍的网络机制

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摘要Abstract

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BACKGROUND: Transcutaneous auricular vagus nerve stimulation (taVNS) is a promising noninvasive intervention for mild cognitive impairment (MCI), but its clinical efficacy and network-level mechanisms remain unclear.

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METHODS: In this prospective, randomized, sham-controlled, parallel-group trial, 60 patients with MCI were assigned 1:1 to 12-week taVNS or sham taVNS. The primary outcome was the between-group difference in change from baseline to week 12 on the Montreal Cognitive Assessment-Basic (MoCA-B). Secondary outcomes included AVLT-H, STT-A/B, AFT, BNT, HAMD-17, and HAMA scores. Twenty-eight healthy controls underwent baseline rs-fMRI as a non-randomized reference cohort. Functional connectivity (FC) identified MCI-related abnormal regions, which together with theory-driven regions served as seeds for Granger causality analysis (GCA) to characterize intervention-related effective connectivity changes. Imaging-behavior associations were examined using Pearson correlations. The final per-protocol analysis included 52 randomized patients with complete clinical and imaging data.

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RESULTS: After 12 weeks, the taVNS group showed significant within-group improvements in global cognition and multiple secondary outcomes, whereas the sham group did not. The between-group difference in MoCA-B change was significant (mean difference = 2.91, 95% CI: 0.79 to 5.03, Cohen's d = 0.59), indicating a moderate-to-large effect. Baseline FC abnormalities in MCI mainly involved the insula, medial frontal cortex, precuneus, temporal cortex, thalamus, cingulate cortex, and parieto-occipital regions. Following taVNS, effective connectivity was selectively reconfigured within a distributed network centered on the insula, anterior cingulate cortex, temporal cortex, and precuneus. Changes in directed connectivity correlated with changes in MoCA-B, AFT, and HAMA scores. No serious adverse events occurred.

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CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/showproj.html?proj=131823, identifier (ChiCTR2100049940).

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