ArticleBrain sciences2025
Auricular Ultrasonic Vagus Nerve Stimulation: Effectiveness of Blinding and Occurrence of Adverse Effects in Healthy Volunteers.
Article in Brain sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Transcutaneous auricular vagus nerve stimulation in drug-resistant epilepsy: A randomized, sham-controlled crossover trial with exploratory EEG and MRI response phenotyping.Epilepsia open · 2026Article
- Auricular Ultrasonic Vagus Nerve Stimulation: Effectiveness of Blinding and the Occurrence of Adverse Effects in People with Tinnitus.Brain sciences · 2026Article
- Transauricular Vagus Nerve Stimulation for Postoperative Analgesia following Arthroscopic Shoulder Surgery: A Double-Blind, Randomized, Placebo-Controlled Trial.Pain and therapy · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
objectivesBoth invasive and non-invasive electrical stimulation of the vagus nerve have been studied as potential treatments for neurological conditions, with mixed results. Ultrasonic Vagus Nerve Stimulation (U-VNS), which non-invasively stimulates the auricular branch of the vagus nerve using ultrasound, may offer a more targeted and effective approach than electric currents. To facilitate future clinical trials of U-VNS, this study aimed to (1) investigate the effectiveness of blinding of a U-VNS device versus a sham device and (2) record the type, onset, and duration of any adverse effects resulting from U-VNS.
methodsIn this single-blind randomised controlled study, twenty healthy volunteers were randomly assigned to receive either a 30 min session of true U-VNS and a 30 min session of sham stimulation 1 week later, or vice versa. The effectiveness of blinding and the occurrence of adverse effects were measured using self-report questionnaires.
resultsJames' Blinding Index showed that blinding using the sham device was highly effective in both the real U-VNS condition, BI = 0.9 (95% CI: 0.7-1.0), and the sham condition, BI = 1.0 (95% CI: 1.0-1.0). The adverse effects reported were mild, transient, and mostly related to sensations on the skin immediately under the transducer of the device.
conclusionsA high level of blinding effectiveness can be achieved for U-VNS by using a sham device. Adverse effects are generally mild and transient. These findings will inform the design of future clinical trials of U-VNS.
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Registered trials
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