此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Parametric Testing of Direct Physiological Effects of Transcutaneous Vagus Nerve Stimulation (tVNS) in Healthy Controls

2016年7月15日 更新者：Medical University of South Carolina

The purpose of this study is to determine the feasibility and safety of Transcutaneous Vagus Nerve Stimulation (tVNS) in healthy controls. Tested in healthy subjects (HS) the physiological effects of tVNS at different stimulation parameters. The electrical stimulation variables will be pulse width, frequency, and current. This will be tested in a laboratory setting and will measure tVNS effects on heart rate, respiration rate, blood pressure, and perceived pain. This is a feasibility and small safety study.

Hypothesis: tVNS is feasible and safe

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

15

阶段

  • 阶段1

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 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Meets none of the Exclusion Criteria

Exclusion Criteria:

  • History of seizures, depression, or pain conditions
  • Taking any prescription medications (excluding contraceptives and statins)
  • History of any ear trauma
  • History of heart conditions
  • Has a heart pacemaker or artificial valve
  • Has a metal implant above the waste
  • Is pregnant
  • Alcohol Dependence
  • Illicit drug use in past 6 months
  • History of brain surgery or lesions
  • History of loss of consciousness (>15 min)
  • Faint at the sight of blood
  • Hospitalization or surgeries in past 6 months

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

  • 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
实验性的：Active tVNS Stimulation
Stimulating electrode will be placed on left tragus of subject. Current will be held constant (200% perceptual threshold) while pulse width and frequency are varied.The intervention used to keep current constant is Digitmer High Voltage Stimulator model DS7A TENS unit. Each stimulation period (9 randomized stimulation parameters varying in pulse width and frequency) will last 1 minute with a 3 minute break between each parameter. Physiological data (O2 saturation, blood pressure, breathing rate, and Electrocardiogram (EKG) to measure heart rate ) will be collected continuously.
设备：Digitmer High Voltage Stimulator model DS7A TENS unit
假比较器：Sham tVNS Stimulation
Stimulating electrode will be placed on left ear lobe of subject for sham tVNS stimulation condition. Current will be held constant (200% perceptual threshold) while pulse width and frequency are varied. The intervention used to keep current constant is Digitmer High Voltage Stimulator model DS7A TENS unit. Each stimulation period (9 randomized stimulation parameters varying in pulse width and frequency) will last 1 minute with a 3 minute break between each parameter. Physiological data (O2 saturation, blood pressure, breathing rate, and Electrocardiogram (EKG) to measure heart rate ) will be collected continuously.
设备：Digitmer High Voltage Stimulator model DS7A TENS unit

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
Change from Baseline Heart Rate Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 1
大体时间：Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)

There are nine stimulation periods, each with own stimulation parameters that consist of a constant current, pulse width and frequency. Each stimulation period has 1 minute of stimulation (active or sham), followed by 3 minutes of post stimulation baseline recording Each of the stimulation period last 4 minutes with an additional 90 seconds between each Stimulation period. Current will be 200% of the subject's perceptual threshold for each stimulation parameter. The pulse width will be either 100 microseconds (µs), 200 µs, or 500µs. Frequency will be either 1 Hertz (Hz), 10 Hz, or 25 Hz.

Baseline physiological data,Electrocardiogram (EKG) to measure heart rate in beats/sec will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter.
Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
Change from Baseline Heart Rate Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 2
大体时间：Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)

There are nine stimulation periods, each with own stimulation parameters that consist of a constant current, pulse width and frequency. Each stimulation period has 1 minute of stimulation (active or sham), followed by 3 minutes of post stimulation baseline recording Each of the stimulation period last 4 minutes with an additional 90 seconds between each Stimulation period. Current will be 200% of the subject's perceptual threshold for each stimulation parameter. The pulse width will be either 100 microseconds (µs), 200 µs, or 500µs. Frequency will be either 1 Hertz (Hz), 10 Hz, or 25 Hz.

Baseline physiological data,Electrocardiogram (EKG) to measure heart rate in beats/sec will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter.
Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
Change from Baseline O2 Saturation Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 1
大体时间：Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)

There are nine stimulation periods, each with own stimulation parameters that consist of a constant current, pulse width and frequency. Each stimulation period has 1 minute of stimulation (active or sham), followed by 3 minutes of post stimulation baseline recording Each of the stimulation period last 4 minutes with an additional 90 seconds between each Stimulation period. Current will be 200% of the subject's perceptual threshold for each stimulation parameter. The pulse width will be either 100 microseconds (µs), 200 µs, or 500µs. Frequency will be either 1 Hertz (Hz), 10 Hz, or 25 Hz.

Baseline physiological data O2 saturation (% oxygen) will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter.
Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
Change from Baseline O2 Saturation Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 2
大体时间：Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)

There are nine stimulation periods, each with own stimulation parameters that consist of a constant current, pulse width and frequency. Each stimulation period has 1 minute of stimulation (active or sham), followed by 3 minutes of post stimulation baseline recording Each of the stimulation period last 4 minutes with an additional 90 seconds between each Stimulation period. Current will be 200% of the subject's perceptual threshold for each stimulation parameter. The pulse width will be either 100 microseconds (µs), 200 µs, or 500µs. Frequency will be either 1 Hertz (Hz), 10 Hz, or 25 Hz.

Baseline physiological data O2 saturation (%oxygen) will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter.
Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline Blood Pressure Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 1
大体时间：Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)

There are nine stimulation periods, each with own stimulation parameters that consist of a constant current, pulse width and frequency. Each stimulation period has 1 minute of stimulation (active or sham), followed by 3 minutes of post stimulation baseline recording Each of the stimulation period last 4 minutes with an additional 90 seconds between each Stimulation period. Current will be 200% of the subject's perceptual threshold for each stimulation parameter. The pulse width will be either 100 microseconds (µs), 200 µs, or 500µs. Frequency will be either 1 Hertz (Hz), 10 Hz, or 25 Hz.

Baseline physiological data Blood Pressure (mmHg) will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter.
Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
Change from Baseline Blood Pressure Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 2
大体时间：Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)

There are nine stimulation periods, each with own stimulation parameters that consist of a constant current, pulse width and frequency. Each stimulation period has 1 minute of stimulation (active or sham), followed by 3 minutes of post stimulation baseline recording Each of the stimulation period last 4 minutes with an additional 90 seconds between each Stimulation period. Current will be 200% of the subject's perceptual threshold for each stimulation parameter. The pulse width will be either 100 microseconds (µs), 200 µs, or 500µs. Frequency will be either 1 Hertz (Hz), 10 Hz, or 25 Hz.

Baseline physiological data Blood Pressure (mmHg) will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter.
Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
Change from Baseline Breathing Rate Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 1
大体时间：Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)

There are nine stimulation periods, each with own stimulation parameters that consist of a constant current, pulse width and frequency. Each stimulation period has 1 minute of stimulation (active or sham), followed by 3 minutes of post stimulation baseline recording Each of the stimulation period last 4 minutes with an additional 90 seconds between each Stimulation period. Current will be 200% of the subject's perceptual threshold for each stimulation parameter. The pulse width will be either 100 microseconds (µs), 200 µs, or 500µs. Frequency will be either 1 Hertz (Hz), 10 Hz, or 25 Hz.

Baseline physiological data breathing rate (%CO2) will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter.
Total time for Visit 1 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)
Change from Baseline Breathing Rate Before Each Stimulation Period (1-9) to Post Stimulation Period (1-9) Visit 2
大体时间：Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)

There are nine stimulation periods, each with own stimulation parameters that consist of a constant current, pulse width and frequency. Each stimulation period has 1 minute of stimulation (active or sham), followed by 3 minutes of post stimulation baseline recording Each of the stimulation period last 4 minutes with an additional 90 seconds between each Stimulation period. Current will be 200% of the subject's perceptual threshold for each stimulation parameter. The pulse width will be either 100 microseconds (µs), 200 µs, or 500µs. Frequency will be either 1 Hertz (Hz), 10 Hz, or 25 Hz.

Baseline physiological data breathing rate (%CO2) will be collected before each stimulation parameter, during stimulation parameter, and post each stimulation parameter.
Total time for Visit 2 (either active or sham condition) is 50 minutes - 9 Stimulation Periods (each 4 minutes long with 90 seconds between)

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。

赞助

Medical University of South Carolina

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

2014年11月1日

初级完成 (实际的)

2015年8月1日

研究注册日期

首次提交

2016年7月6日

首先提交符合 QC 标准的

2016年7月15日

首次发布 (估计)

2016年7月18日

研究记录更新

最后更新发布 (估计)

2016年7月18日

上次提交的符合 QC 标准的更新

2016年7月15日

最后验证

2016年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • Pro00038301

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

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.

订阅