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<p>Negative symptoms in treatment-resistant schizophrenia (TRS) are notably persistent and minimally affected by antipsychotics, the transcutaneous auricular vagus nerve stimulation (taVNS) is a promising treatment approach. However, clinical trials are scarce, and further efficacy data are needed. We conducted a double-blind, sham-controlled, randomized clinical trial to determine the efficacy and safety of taVNS as an add-on treatment for patients with TRS with predominantly negative symptoms and to investigate potential biomarkers of efficacy. A total of 50 patients underwent a two-week intervention of active taVNS (n = 25) or sham taVNS (n = 25), followed by a two-week follow-up. Primary outcome was the change in the PANSS-factor score for negative symptoms (PANSS-FSNS) assessed after the intervention. In the intention-to-treat analysis, patients receiving active taVNS showed a significantly greater improvement in negative symptoms compared with those receiving the sham procedure (PANSS-FSNS difference, −1.36; effect size, −0.62; 95% CI, −1.20 to −0.04; <i>p</i> = 0.033), with effects sustained at follow-up and good tolerability. Inflammatory cytokines and EEG coherence showed that in the active group, the change in PANSS-FSNS scores after treatment was significantly correlated with changes in tumour necrosis factor (TNF)-α (<i>r</i> = 0.56, corrected <i>p</i> = 0.017) and beta-band coherence between the left frontal and parietal regions (<i>r</i> = −0.56, <i>p</i> = 0.004), but not in the sham group. This study suggests that taVNS may effectively and safely ameliorate negative symptoms in TRS, with TNF-α and beta-band coherence between the left frontal and parietal regions as potential sensitivity efficacy biomarkers. Chinese Clinical Trial Registry (<a href="http://www.chictr.org.cn">http://www.chictr.org.cn</a>.), ChiCTR2400085198.</p>

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Efficacy and safety of transcutaneous auricular vagus nerve stimulation for patients with treatment-resistant schizophrenia with predominantly negative symptoms: a randomized clinical trial and efficacy sensitivity biomarkers

  • 期刊论文

  • 发表日期：

    2025年8月26日

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  • Yapeng Cui,
  • Jinbo Sun,
  • Bingkui Zhang,
  • Taipin Guo,
  • Shumin Zhang,
  • Zhiqin Li,
  • Ying Chen,
  • Mingbing Su,
  • Dongniya Wu,
  • Jingxia Wu,
  • Qian Wang,
  • Yangyang Yuan,
  • Jianan Wang,
  • Qianqian Tian,
  • Fang He,
  • Lei Wu,
  • Xinghua Li,
  • Yi Gong,
  • Wei Qin

摘要

Negative symptoms in treatment-resistant schizophrenia (TRS) are notably persistent and minimally affected by antipsychotics, the transcutaneous auricular vagus nerve stimulation (taVNS) is a promising treatment approach. However, clinical trials are scarce, and further efficacy data are needed. We conducted a double-blind, sham-controlled, randomized clinical trial to determine the efficacy and safety of taVNS as an add-on treatment for patients with TRS with predominantly negative symptoms and to investigate potential biomarkers of efficacy. A total of 50 patients underwent a two-week intervention of active taVNS (n = 25) or sham taVNS (n = 25), followed by a two-week follow-up. Primary outcome was the change in the PANSS-factor score for negative symptoms (PANSS-FSNS) assessed after the intervention. In the intention-to-treat analysis, patients receiving active taVNS showed a significantly greater improvement in negative symptoms compared with those receiving the sham procedure (PANSS-FSNS difference, −1.36; effect size, −0.62; 95% CI, −1.20 to −0.04; p = 0.033), with effects sustained at follow-up and good tolerability. Inflammatory cytokines and EEG coherence showed that in the active group, the change in PANSS-FSNS scores after treatment was significantly correlated with changes in tumour necrosis factor (TNF)-α (r = 0.56, corrected p = 0.017) and beta-band coherence between the left frontal and parietal regions (r = −0.56, p = 0.004), but not in the sham group. This study suggests that taVNS may effectively and safely ameliorate negative symptoms in TRS, with TNF-α and beta-band coherence between the left frontal and parietal regions as potential sensitivity efficacy biomarkers. Chinese Clinical Trial Registry (http://www.chictr.org.cn.), ChiCTR2400085198.