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临床试验/NCT06975124
NCT06975124招募中1 期

taVNS Effects on Fear Ratings in Naturalistic Context

University of Electronic Science and Technology of China1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
Neural activity changes between groups

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Neural activity changes between groups

时间窗: 10 minutes

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

Fear ratings between groups

时间窗: 10 minutes

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

Functional connectivity witnin frontal regions between groups

时间窗: 10 minutes

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

The correlation between brain activity and behavioral ratings across groups

时间窗: 10 minutes

The correlation between brain activity and behavioral ratings across groups

次要结局

  • Skin conductance response between groups(10 minutes)

研究者

发起方
University of Electronic Science and Technology of China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weihua Zhao

Associate Professor

University of Electronic Science and Technology of China

研究点 (1)

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