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外耳刺激对痛觉和情绪的影响

Background:

The vagus nerve runs from the brain to many organs. Stimulating it can affect the experience of pain. The nerve can be stimulated on the surface of the left ear. Researchers want to study how this stimulation affects the perception of pain. They also want to study how mood affects the experience of pain.

Objective:

To study the effects of mood and vagus nerve stimulation on the experience of pain.

Eligibility:

Healthy people ages 18 and older who are fluent in English

Design:

Participants will be pre-screened with a 15-minute phone call.

Participants will have three 2-hour visits.

At the screening visit, participants will be screened with:

Medical and psychiatric history

Physical and psychological exams

Questionnaires about physical and psychiatric health and mood

Urine tests

A heat probe on the forearm. The temperature will be increased until it is painful

but tolerable.

Participants will have 2 testing sessions within 7 days. Before the testing, they cannot do the following:

Eat, use nicotine, or exercise for at least 2 hours

Drink alcohol for 24 hours

Take certain medicines for 3 days

Testing includes:

Urine drug screening

Left ear stimulation: In one session, the vagus nerve will be stimulated. In the other, an area

of the ear away from the vagus nerve will be stimulated. This will be done with mild electric

shocks that cause a tingling, pricking, or itchy feeling.

Heat applied to the forearm until it is painful but tolerable

Completing several forms on a computer or on paper about how they are feeling

Monitors on the chest and a finger clip to monitor heart, breathing, and blood pressure

研究概览

详细说明

This double-blind, randomized, controlled, cross-over study on healthy participants will evaluate the perceptual differences of pain and changes in mood in response to peripheral nerve stimulation over two regions of the left external ear. A series of short and long duration heat stimuli will be applied to the participants forearms and they will be asked to rate their current mood state, the intensity of the pain, and whether it was pleasant or unpleasant. The series of heat stimuli will be applied before, during, and after mild electrical stimulation of the left external ear using a commercially available TENS unit. There are two study sessions. Session 1 involves eligibility screening, a brief practice session, followed by the testing session. In Session 2 (no more than 7 days later), the testing session will be repeated with the exception of the location of ear stimulation. Up to 76 people, ages 18-50 years old, will be enrolled in the study.

研究类型

介入性

注册 (实际的)

70

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。

学习地点

    • Maryland
      • Bethesda、Maryland、美国、20892
        • National Institutes of Health Clinical Center

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

18年 至 50年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

  • INCLUSION CRITERIA:

All subjects must be:

  1. between 18 and 50 years old.
  2. fluent in English.
  3. able to provide written informed consent.

EXCLUSION CRITERIA:

Overall exclusion criteria for the study

  1. Unable to comply with study procedures or visits (including inability to schedule the second session within 10 business days of the first session).
  2. Is pregnant or breastfeeding.
  3. Has ears with indiscernible structures (e.g., cymba conchae, earlobe) due to congenital malformations, accidents, or physical alterations (e.g., "gauge", cartilage piercing).
  4. Has a dermatological condition such as scars or burns, or has had a tattoo in the testing region within the previous four weeks that might influence cutaneous sensibility.
  5. Women who consume more than 7 alcoholic beverages per week, and men who consume more than 14 drinks per week.
  6. Has a current chronic pain condition or has had chronic pain in the past year (painful condition lasting more than six months).
  7. Has a major medical condition, such as kidney, liver, cardiovascular, autonomic, pulmonary, or neurological problems (e.g., epilepsy) or a chronic systemic disease (e.g., diabetes).
  8. Has or had psychiatric disorders such as major depression, major anxiety-related problems, post-traumatic stress syndrome, bipolar disorder, psychosis, or alcohol or substance abuse disorders as identified by the MINI International Neuropsychiatric Interview questionnaire, which will be administered as part of the screening procedure.
  9. Has a medical condition potentially affecting cardiac functioning (e.g. arrhythmias, bradycardia [<60 beats per min; determined during screening]) or Raynaud s Disease or other medical condition affecting peripheral vascular sensitivity.
  10. Is actively taking medications that are known to interfere with current measurements of pain or autonomic function. These include but are not limited to: opioids, antidepressants (such as tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors), anticonvulsants (including gabapentin and pregabalin), and blood pressure medications (including beta-blockers, calcium channel blockers, and ACE inhibitors). Participants who have used such medications in the last three months must have ceased taking them for at least one month or three medication half-lives (whichever is longer) in order to be included.
  11. Baseline heat pain threshold exceeds 46 degrees C (to be determined after consent).
  12. Has ever had acupuncture in or around any area of the ears.
  13. NIH employees are subordinates, relatives, or co-workers of the investigators, or NCCIH DIR employees.

Exclusion criteria for individual study session*

  1. Has consumed alcohol within 24 hours, shows signs of alcohol withdrawal syndrome, or has behavioral signs of intoxication.

  2. Has exercised or eaten within two hours of testing session.

  3. Used nicotinic substances (e.g., tobacco, gum, "e-cigarette") within 2 hours of testing.

  4. Used topical pain-relieving creams in the testing area (e.g. methylsalicylate, capsaicin) within 24 hours of testing.

  5. Used non-steroidal anti-inflammatory drugs (NSAIDS, e.g. aspirin, ibuprofen), acetaminophen, naproxen, sumatriptan within 3 days of testing.

    • To be determined during the pre-session screening. Participants that cannot refrain from these activities may have their session rescheduled up to two times. If the participant is found non-compliant during the second rescheduled appointment, he or she will be excluded from 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:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Cymba Conchae

Mild electrical stimulation is applied to the cymba conchae of the left ear, and thermal stimulation is applied to the arms.

Mild transcutaneous electrical stimulation will be applied to the cymba conchae of the left ear on day 1 and the left earlobe on day 2 (or vice versa) using a commercially available TENS unit (transcutaneous electrical nerve stimulator) attached to a pair of silver electrodes.

Device used to apply Thermal stimulation to both arms.

有源比较器:Ear Lobe

Mild electrical stimulation is applied to the earlobe of the left ear, and thermal stimulation is applied to the arms.

Mild transcutaneous electrical stimulation will be applied to the cymba conchae of the left ear on day 1 and the left earlobe on day 2 (or vice versa) using a commercially available TENS unit (transcutaneous electrical nerve stimulator) attached to a pair of silver electrodes.

Device used to apply Thermal stimulation to both arms.

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
The difference in pain ratings collected for each subject during the two types of left ear stimulation (cymba conchae and earlobe).
大体时间:End of study

See measures

End of study

次要结果测量

结果测量
措施说明
大体时间
The effect of tVNS on pain threshold, pain unpleasantness, and mood as measured by visual analogue scales (VAS).
大体时间:End of Study

See measures

End of Study
Mood and anxiety, as measured by questionnaires taken at the beginning and end of both study sessions.
大体时间:End of study

See measures

End of study
Autonomic measures will be analyzed to determine whether tVNS has an effect on heart rate variability.
大体时间:End of study

See measures

End of study

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:Alisa J Johnson、National Center for Complementary and Integrative Health (NCCIH)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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 (实际的)

2016年10月18日

初级完成 (实际的)

2026年9月16日

研究完成 (实际的)

2026年9月16日

研究注册日期

首次提交

2016年6月29日

首先提交符合 QC 标准的

2016年7月1日

首次发布 (估计的)

2016年7月4日

研究记录更新

最后更新发布 (实际的)

2026年9月22日

上次提交的符合 QC 标准的更新

2026年9月19日

最后验证

2026年9月16日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 160136
  • 16-AT-0136

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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

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.

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