A Phase 1 interventional study of transcutaneous auricular vagus nerve stimulation and Sham condition in Healthy Participants, sponsored by University of Electronic Science and Technology of China. Recruiting at 1 site in China. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by University of Electronic Science and Technology of China · Phase 1, Interventional, and Treatment
During the fear rating task, 70 participants viewed a 600-second horror movie while continuously rating their subjective fear intensity (0-100 scale) every 0.51 seconds (1,170 total ratings). Functional near-infrared spectroscopy (fNIRS) data were simultaneously recorded using the NIRSIT LITE system to monitor cortical hemodynamic responses.
In a sham-controlled, participant-blinded, between-subjects design, 70 participants were randomly assigned to either active transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation. The taVNS group received stimulation via a modified transcutaneous electrical acupoint stimulation device, with ear clip electrodes attached to the left cymba conchae to target vagus nerve branches. The sham group received identical electrode placement on the left earlobe, a non-vagus-innervated site. Stimulation intensity was individually calibrated to a perceptible but non-painful level to ensure vagal activation while maintaining participant comfort.
Upon arrival, all participants completed standardized mood and trait questionnaires. To assess emotional and physiological changes, two administrations of the Positive and Negative Affect Schedule (PANAS) and blood pressure/pulse measurements (pre- and post-intervention) were conducted. During the fear rating task, participants viewed a 600-second horror movie while continuously rating their subjective fear intensity (0-100 scale) every 0.51 seconds (1,170 total ratings). Functional near-infrared spectroscopy (fNIRS) data were simultaneously recorded using the NIRSIT LITE system to monitor cortical hemodynamic responses. Additionally, skin conductance responses were measured vy BIOPAC MP150 system.
University of Electronic Science and Technology of China is the lead sponsor of 109 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy participants without color blindness, current or regular substance or medication use, any current or history of medical or psychiatric disorders and contraindications for MRI.
Exclusion Criteria:
Eear clip electrodes were attached to the left cymba conchae to target vagus nerve branches.
Device: transcutaneous auricular vagus nerve stimulation
Electrode placements were attached on the left earlobe
Device: Sham condition
Ear clip electrodes attached to the left cymba conchae to target vagus nerve branches.
Electrode placement attached on the left earlobe.
Neural activity changes between groups
The differences in the activity of frontal regions between groups using fNIRS
Time frame: 10 minutes
Fear ratings between groups
The differences in the fear ratings (0-100, from neutral to extremely fearful) between groups
Time frame: 10 minutes
Functional connectivity witnin frontal regions between groups
The differences in the functional connectivity within frontal regions using fNIRS between groups
Time frame: 10 minutes
The correlation between brain activity and behavioral ratings across groups
The correlation between brain activity and behavioral ratings across groups
Time frame: 10 minutes
Skin conductance response between groups
The differences in the skin conductance response during watching video between groups
Time frame: 10 minutes
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University of Electronic Science and Technology of China