Accelerated Transcutaneous Auricular Vagus Nerve Stimulation for Inpatient Depression and Anxiety: The iWAVE Open Label Pilot Trial

Neuromodulation. 2025 Mar 19:S1094-7159(25)00032-7. doi: 10.1016/j.neurom.2025.02.003. Online ahead of print.

ABSTRACT

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.

PMID:40117415 | DOI:10.1016/j.neurom.2025.02.003