The Effects of Transcutaneous Vagus Nerve Stimulation (tVNS) on Acute Pain Perception and Brain Activity in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain intensity measured by the Numerical Pain Rating Scale
研究概览
简要总结
The goal of this clinical trial is to learn whether stimulating a nerve in the neck changes how much pain people feel. It also looks at whether this stimulation changes brain activity. The study is being done in healthy adults ages 18 to 70.
The nerve being studied is called the vagus nerve. It runs through the neck and connects to parts of the brain that handle pain. In this study, the nerve is stimulated from outside the body using a small device placed on the skin. There is no surgery, and nothing is implanted.
The main questions it aims to answer are: (1) Does stimulating the vagus nerve lower the pain people feel during a cold water test? (2) Does stimulating the vagus nerve change the electrical activity in the brain?
Researchers will compare pain ratings and brain activity under three conditions in the same person: no stimulation, real stimulation over the vagus nerve, and sham stimulation placed nearby on the neck. Sham stimulation feels similar but is not aimed at the nerve.
Participants will: (1) Come to one visit that lasts about 90 minutes, with no follow-up visits, (2) Wear a cap that records the brain's natural electrical signals for the whole visit, (3) Place both hands in cold water, about 39 degrees Fahrenheit, up to three times for up to 2 minutes each time, (4) Rate their pain after each cold water test, (5) Wear a stimulation device on the neck during two of the three cold water tests, (6) Not be told which of those two is the real stimulation until the visit is over.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 70 years
- •Healthy, defined as having no history of chronic medical, neurological, or psychiatric conditions
- •Not currently experiencing acute illness or chronic pain
- •Not currently taking medications that influence the nervous system or pain sensitivity
- •Willing and able to provide written informed consent in English
排除标准
- •History of vagal or vasovagal symptoms
- •Respiratory distress
- •Cardiac arrhythmia
- •Sleep apnea
- •Pregnancy
- •Substance abuse
- •Primary psychiatric disorder
- •Prior vagus nerve stimulation or any implanted medical device
- •Significant acute or chronic neurologic illness that, in the judgment of the Principal Investigator, could compromise participant safety, limit the ability to complete the study, or compromise the objectives of the study
研究组 & 干预措施
Active Stimulation First, Then Sham
Participants complete a cold pressor test with no stimulation, then a second cold pressor test during active transcutaneous vagus nerve stimulation, then a third during sham stimulation.
干预措施: Active transcutaneous vagus nerve stimulation (Device)
Active Stimulation First, Then Sham
Participants complete a cold pressor test with no stimulation, then a second cold pressor test during active transcutaneous vagus nerve stimulation, then a third during sham stimulation.
干预措施: Sham transcutaneous vagus nerve stimulation (Device)
Active Stimulation First, Then Sham
Participants complete a cold pressor test with no stimulation, then a second cold pressor test during active transcutaneous vagus nerve stimulation, then a third during sham stimulation.
干预措施: Cold pressor test (Other)
Sham Stimulation First, Then Active
Participants complete a cold pressor test with no stimulation, then a second cold pressor test during sham stimulation, then a third during active transcutaneous vagus nerve stimulation.
干预措施: Active transcutaneous vagus nerve stimulation (Device)
Sham Stimulation First, Then Active
Participants complete a cold pressor test with no stimulation, then a second cold pressor test during sham stimulation, then a third during active transcutaneous vagus nerve stimulation.
干预措施: Sham transcutaneous vagus nerve stimulation (Device)
Sham Stimulation First, Then Active
Participants complete a cold pressor test with no stimulation, then a second cold pressor test during sham stimulation, then a third during active transcutaneous vagus nerve stimulation.
干预措施: Cold pressor test (Other)
结局指标
主要结局
Pain intensity measured by the Numerical Pain Rating Scale
时间窗: Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
Participant-reported pain intensity on an 11-point scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. Higher scores indicate greater pain. Rated immediately after each cold pressor test.
Pain intensity measured by the Visual Analogue Scale
时间窗: Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
Participant-reported pain intensity is marked on a 100 mm line anchored at 0 mm for no pain and 100 mm for the worst imaginable pain. The distance in millimeters from the left anchor is recorded as the score. Higher scores indicate greater pain. Rated immediately after each cold pressor test.
Pain threshold during cold pressor test
时间窗: During each of the three cold pressor tests within a single visit, approximately 90 minutes.
Time in seconds from hand immersion to the participant's first verbalized sensation of pain, recorded separately for each hand.
次要结局
- Change in EEG spectral power(Continuously throughout a single visit, approximately 90 minutes.)
- Change in EEG functional connectivity(Continuously throughout a single visit, approximately 90 minutes.)
研究者
David A. Purger
Assistant Professor of Neurological Surgery, Adjunct Assistant Professor of Psychiatry Indiana University School of Medicine
Indiana University