跳至主要内容
临床试验/NCT04455295
NCT04455295Unknown不适用

Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation

Arkansas Tech University2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
55
试验地点
2
主要终点
Pupil Diameter

研究概览

简要总结

This study investigates the capacity of non-invasive vagus nerve stimulation, applied at the ear, to alter to measures of locus coeruleus output pupil diameter and EEG alpha power. Non-invasive alteration in locus coeruleus output is of interest in regard to basic science and has potential clinical implications in a number of conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Healthy, 18 years of age or older.

排除标准

  • self-report of mood disorders, prescription and non-prescription drug use which includes stimulants including caffeine and nicotine

研究组 & 干预措施

Active Stimulation 0.5

Experimental

0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles.

干预措施: Transdermal Vagus Nerve Stimulation (tVNS) (Device)

Lobe Control

Placebo Comparator

0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the earlobe. Stimulation 30 second on/30 seconds off for five cycles.

干预措施: Transdermal Vagus Nerve Stimulation (tVNS) (Device)

Sham Stimulation

Placebo Comparator

0.5mA, 5Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles.

干预措施: Transdermal Vagus Nerve Stimulation (tVNS) (Device)

Nonstimulation

Placebo Comparator

Placement of electrode without any stimulation.

干预措施: Transdermal Vagus Nerve Stimulation (tVNS) (Device)

结局指标

主要结局

Pupil Diameter

时间窗: Within single one hour session

Pupil diameter is measured via camera.

EEG Alpha power.

时间窗: Within single one hour session

Alpha power will be determined from EEG.

次要结局

未报告次要终点

研究者

发起方
Arkansas Tech University
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验