Effects of Transcutaneous Vagus Nerve Stimulation on Pain and Brain Activity in Healthy Adults
2026年9月14日 更新者：David A. Purger
The Effects of Transcutaneous Vagus Nerve Stimulation (tVNS) on Acute Pain Perception and Brain Activity in Healthy Adults
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.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Caliel Hines
- 电话号码：317-963-7010
- 邮箱：calhines@iu.edu
研究联系人备份
- 姓名：Marissa Lowe
- 邮箱：lowemj@iu.edu
学习地点
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Indiana
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Indianapolis、Indiana、美国、46202
- IU Health Neuroscience Center
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接触：
- Department of Neurological Surgery
- 电话号码：317-963-1300
- 邮箱：dpurger@iu.edu
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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Stimulation applied over the cervical branch of the vagus nerve, anterior to the sternocleidomastoid along the carotid sheath.
Pulse width 200 microseconds, frequency 30 Hz, rectangular monophasic waveform, intensity titrated between 17.8 and 39.5 volts to a mild tingling sensation below the threshold of discomfort.
Stimulation is maintained for 20 minutes before the cold pressor test and continues throughout it.
Identical device, parameters, and duration as the active condition, differing only in placement.
The device is positioned slightly posterior on the neck, away from the cervical branch of the vagus nerve.
Immersion of both hands up to the wrist in water maintained at 4 degrees Celsius with ice for up to two minutes or as long as tolerated.
Performed three times per participant: once with no stimulation, once during active stimulation, and once during sham stimulation.
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实验性的：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.
|
Stimulation applied over the cervical branch of the vagus nerve, anterior to the sternocleidomastoid along the carotid sheath.
Pulse width 200 microseconds, frequency 30 Hz, rectangular monophasic waveform, intensity titrated between 17.8 and 39.5 volts to a mild tingling sensation below the threshold of discomfort.
Stimulation is maintained for 20 minutes before the cold pressor test and continues throughout it.
Identical device, parameters, and duration as the active condition, differing only in placement.
The device is positioned slightly posterior on the neck, away from the cervical branch of the vagus nerve.
Immersion of both hands up to the wrist in water maintained at 4 degrees Celsius with ice for up to two minutes or as long as tolerated.
Performed three times per participant: once with no stimulation, once during active stimulation, and once during sham stimulation.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain intensity measured by the Numerical Pain Rating Scale
大体时间：Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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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.
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Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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Pain intensity measured by the Visual Analogue Scale
大体时间：Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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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.
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Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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Pain threshold during cold pressor test
大体时间：During each of the three cold pressor tests within a single visit, approximately 90 minutes.
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Time in seconds from hand immersion to the participant's first verbalized sensation of pain, recorded separately for each hand.
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During each of the three cold pressor tests within a single visit, approximately 90 minutes.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in EEG spectral power
大体时间：Continuously throughout a single visit, approximately 90 minutes.
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Change in spectral power within canonical frequency bands (delta 1 to 4 Hz, theta 4 to 8 Hz, alpha 8 to 12 Hz, beta 13 to 30 Hz, gamma above 30 Hz), measured by continuous 16-channel electroencephalography, compared across resting baseline, stimulation without noxious stimulus, and stimulation during cold pressor test.
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Continuously throughout a single visit, approximately 90 minutes.
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Change in EEG functional connectivity
大体时间：Continuously throughout a single visit, approximately 90 minutes.
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Change in functional connectivity between brain regions, derived from continuous 16-channel electroencephalography.
Phase locking values are computed for each pair of EEG channels within canonical frequency bands, and connectivity metrics are derived from those values.
Coherence is assessed in the frequency domain.
Analyses are restricted to predefined, theory-driven regions and frequency bands.
Compared across resting baseline, stimulation without noxious stimulus, and stimulation during the cold pressor test.
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Continuously throughout a single visit, approximately 90 minutes.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：David A Purger, MD, PhD、Indiana University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2028年1月1日
研究完成 (估计的)
2028年1月1日
研究注册日期
首次提交
2026年9月14日
首先提交符合 QC 标准的
2026年9月14日
首次发布 (实际的)
2026年9月18日
研究记录更新
最后更新发布 (实际的)
2026年9月18日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 27960
- SNEU-IIR-TVNS-ADULTS (其他标识符：Indiana University IRB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
This is a small exploratory pilot study in healthy volunteers, designed to generate preliminary effect size estimates rather than definitive findings.
With a target enrollment of 20 participants at a single site, the dataset is small enough that a decision about sharing individual participant data has been deferred.
The current informed consent form does not specifically address sharing de-identified individual participant data with researchers outside the study team.
Any future data sharing would require review of participant consent and approval by the Indiana University Institutional Review Board.
The study team will revisit this decision before study completion.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.