taVNS Effects on Fear Ratings in Naturalistic Context

NCT ID: NCT06975124

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-07-31

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.

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

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

taVNS group

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

Group Type: ACTIVE_COMPARATOR

transcutaneous auricular vagus nerve stimulation

Intervention Type: DEVICE

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

Sham group

Electrode placements were attached on the left earlobe

Group Type: SHAM_COMPARATOR

Sham condition

Intervention Type: DEVICE

Electrode placement attached on the left earlobe.

Interventions

transcutaneous auricular vagus nerve stimulation

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

Intervention Type: DEVICE

Sham condition

Electrode placement attached on the left earlobe.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Electronic Science and Technology of China

OTHER

Sponsor Role: lead

Responsible Party

Weihua Zhao

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nirsit Lite

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Weihua Zhao, Phd

Role: primary

zarazhao@uestc.edu.cn

+86 18780247797

Other Identifiers

UESTC-neuSCAN-100

Identifier Type: -

Identifier Source: org_study_id