taVNS Effects on Fear Ratings in Naturalistic Context

NCT06975124 | Recruiting Phase 1

• 1 other identifier: UESTC-neuSCAN-100
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• Neural activity changes between groups

  The differences in the activity of frontal regions between groups using fNIRS

  10 minutes

• Fear ratings between groups

  The differences in the fear ratings (0-100, from neutral to extremely fearful) between groups

  10 minutes

• Functional connectivity witnin frontal regions between groups

  The differences in the functional connectivity within frontal regions using fNIRS between groups

  10 minutes

• The correlation between brain activity and behavioral ratings across groups

  The correlation between brain activity and behavioral ratings across groups

  10 minutes

Secondary Outcomes (1)

• Skin conductance response between groups

  10 minutes

Study Arms (2)

taVNS group

ACTIVE COMPARATOR

Eear clip electrodes were attached to the left cymba conchae to target vagus nerve branches.

Device: transcutaneous auricular vagus nerve stimulation

Sham group

SHAM COMPARATOR

Electrode placements were attached on the left earlobe

Device: Sham condition

Interventions

transcutaneous auricular vagus nerve stimulation DEVICE

Ear clip electrodes attached to the left cymba conchae to target vagus nerve branches.

taVNS group

Sham condition DEVICE

Electrode placement attached on the left earlobe.

Sham group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Color blindness,
• Current or regular substance or medication use
• any current or history of medical or psychiatric disorders and contraindications for MRI

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

Nirsit Lite

Chengdu, Sichuan, 611731, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 16, 2025
• Study Start: March 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: July 31, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

CN (1)