Austelle Christopher W, Cox Stewart S, Connolly Dillon J, Baker Vogel Brenna, Peng Xiaolong, Wills Kristin, Sutton Falon, Tucker Katherine B, Ashley Ethan, Manett Andrew, Cortese Bernadette, Short Edward Baron, Badran Bashar W
Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA; Mental Illness Research, Education, and Clinical Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA.
Department of Psychiatry and Behavioral Sciences, Neuro-X Lab, Medical University of South Carolina, Charleston, SC, USA.
Neuromodulation. 2025 Jun;28(4):672-681. doi: 10.1016/j.neurom.2025.02.003. Epub 2025 Mar 19.
INTRODUCTION: Brain stimulation is not a common inpatient psychiatric treatment; however, there are an increasing number of neuromodulation treatments approved for psychiatric indications. Noninvasive techniques, such as transcutaneous auricular vagus nerve stimulation (taVNS), are promising and should be investigated in this novel setting. This study evaluates the safety and feasibility of taVNS on the inpatient psychiatric unit and preliminarily explores efficacy for comorbid depression and anxiety. MATERIALS AND METHODS: Ten adult patients (five women, mean age ± SD, 35.60 ± 19.14 years) admitted to the inpatient psychiatric unit with comorbid depression and anxiety participated in this open-label safety and feasibility trial. Patients were randomized to receive one of two taVNS dosing approaches: 1) three taVNS sessions on three consecutive days (nine sessions total) (n = 5) or 2) nine taVNS sessions in one day (n = 5). Each day, we assessed depression, using the Patient Health Questionnaire (PHQ-9) and Beck Depression Inventory (BDI), and anxiety, using the Generalized Anxiety Disorder-7 (GAD-7) and Beck Anxiety Inventory (BAI). RESULTS: Both taVNS dosing approaches were safe and feasible in this novel setting. There were no serious adverse events, and we observed a low rate of minor adverse effects, which was similar across treatment conditions. Regardless of condition, stimulation significantly reduced GAD-7 (mean reduction ± SD, -5.90 to 6.87, p < 0.05), BAI (-9.40 ± 10.52, p < 0.05), PHQ-9 (-6.00 ± 7.57, p < 0.05), and BDI (-11.00 ± 11.59, p < 0.05) final scores compared with baseline. There was not a significant difference in clinical response between treatment conditions. DISCUSSION: In this open label study, taVNS significantly decreased depression and anxiety symptoms in patients admitted to the inpatient unit. The small sample size in this trial limited our ability to characterize patient characteristics that may drive response. However, our results suggest taVNS may be an effective adjunct to inpatient psychiatric treatment and should continue to be studied in this setting. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT05791383.
引言：脑刺激并非常见的住院精神科治疗方法；然而，目前有越来越多的神经调节治疗方法被批准用于精神科适应症。非侵入性技术，如经皮耳迷走神经刺激（taVNS），前景广阔，应在这种新环境中进行研究。本研究评估了taVNS在住院精神科病房的安全性和可行性，并初步探讨其对共病抑郁和焦虑的疗效。 材料与方法：十名因共病抑郁和焦虑而入住住院精神科病房的成年患者（五名女性，平均年龄±标准差，35.60±19.14岁）参与了这项开放标签的安全性和可行性试验。患者被随机分配接受两种taVNS给药方式之一：1）连续三天进行三次taVNS治疗（共九次治疗）（n = 5）或2）一天进行九次taVNS治疗（n = 5）。每天，我们使用患者健康问卷（PHQ - 9）和贝克抑郁量表（BDI）评估抑郁情况，使用广泛性焦虑障碍量表（GAD - 7）和贝克焦虑量表（BAI）评估焦虑情况。 结果：在这种新环境中，两种taVNS给药方式均安全可行。未出现严重不良事件，我们观察到轻微不良反应发生率较低，且在不同治疗条件下相似。无论治疗条件如何，与基线相比，刺激均显著降低了GAD - 7（平均降低值±标准差，-5.90至6.87，p < 0.05）、BAI（-9.40±10.52，p < 0.05）、PHQ - 9（-6.00±7.57，p < 0.05）和BDI（-11.00±11.59，p < 0.05）的最终得分。不同治疗条件之间的临床反应无显著差异。 讨论：在这项开放标签研究中，taVNS显著降低了住院患者的抑郁和焦虑症状。本试验样本量较小，限制了我们描述可能影响反应的患者特征的能力。然而，我们的结果表明taVNS可能是住院精神科治疗的一种有效辅助手段，应继续在这种环境中进行研究。 临床试验注册：该研究在Clinicaltrials.gov上的注册号为NCT05791383。
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