taVNS Effects on Fear Ratings in Naturalistic Context
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcutaneous auricular vagus nerve stimulation, Sham condition.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: 18 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Device transcutaneous auricular vagus nerve stimulation
Ear clip electrodes attached to the left cymba conchae to target vagus nerve branches. - Device Sham condition
Electrode placement attached on the left earlobe.
Primary outcome measures
- Neural activity changes between groups [Time frame: 10 minutes]
- Fear ratings between groups [Time frame: 10 minutes]
- Functional connectivity witnin frontal regions between groups [Time frame: 10 minutes]
- The correlation between brain activity and behavioral ratings across groups [Time frame: 10 minutes]
Secondary outcome measures (1)
- Skin conductance response between groups [Time frame: 10 minutes]
Eligibility criteria
Inclusion criteria
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
- Color blindness,
- Current or regular substance or medication use
- any current or history of medical or psychiatric disorders and contraindications for MRI
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Nirsit Lite — Chengdu
Identifiers
NCT: NCT06975124 · UESTC-neuSCAN-100