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RecruitingNCT06975124

taVNS Effects on Fear Ratings in Naturalistic Context

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
70 (estimated)
Sponsor
University of Electronic Science and Technology of China · Academic / Other
Sex
All
Age
18 Years – 30 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEtranscutaneous auricular vagus nerve stimulationEar clip electrodes attached to the left cymba conchae to target vagus nerve branches.
DEVICESham conditionElectrode placement attached on the left earlobe.

Timeline

Start date
2025-03-01
Primary completion
2025-06-01
Completion
2025-07-31
First posted
2025-05-16
Last updated
2025-05-16

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06975124. Inclusion in this directory is not an endorsement.

taVNS Effects on Fear Ratings in Naturalistic Context (NCT06975124) · Clinical Trials Directory