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经皮迷走神经刺激注意力和记忆力 (taVNS)

2026年10月1日 更新者:Ricardo Jorge, MD、Baylor College of Medicine

经皮耳迷走神经刺激对注意力和工作记忆的影响:一项试点研究

This clinical trial aims to evaluate whether transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive brain stimulation method, can improve attention and memory in veterans with traumatic brain injury (TBI) and depression and/or posttraumatic stress disorder (PTSD). The study seeks to answer two main questions:

  1. Can active taVNS improve attention and memory compared to sham (placebo) stimulation?
  2. Does taVNS affect heart rate variability (HRV)?

taVNS delivers a gentle electrical current to the vagus nerve through electrodes placed on the ear, targeting brain areas involved in attention and memory without requiring surgery.

This study uses a crossover design, meaning all participants will experience two sessions: one with active taVNS and one with sham stimulation. The sham session feels similar but does not deliver actual stimulation, allowing researchers to compare the two and understand taVNS's effects on the brain.

In a single visit, participants will:

  • Complete eligibility screening (questionnaires and vital signs).
  • Undergo two sessions (one active and one sham), randomly assigned.
  • Perform attention tasks before and after each session.
  • Have their heart rate monitored during the sessions.

The findings will help determine whether taVNS could be an effective treatment for improving attention and memory in veterans with TBI.

研究概览

详细说明

Attention and memory problems are common in veterans with traumatic brain injuries (TBI), particularly when accompanied by depression and/or posttraumatic stress disorder (PTSD). Current treatments for these issues often have limited effectiveness or unwanted side effects. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive technique that uses gentle electrical impulses delivered through electrodes placed on the ear. This stimulation targets the vagus nerve, which plays a key role in regulating brain areas involved in attention and memory. By enhancing the activity of these brain regions, taVNS shows potential as a novel treatment option for improving cognitive functions like attention and memory.

In this study, researchers aim to determine whether taVNS can enhance attention and memory in veterans with TBI. Participants will complete a single study visit lasting 2.5 to 3 hours. The visit includes two taVNS sessions, one active and one sham (placebo), to compare their effects. Sham stimulation mimics the sensation of taVNS but does not deliver electrical current to the vagus nerve. This design allows researchers to isolate the specific effects of taVNS.

Procedures:

  1. Screening (40 minutes):

    Participants will begin by completing questionnaires about their medical history, memory concerns, alcohol and substance use, mood, and demographics. Vital signs (heart rate, blood pressure, and temperature) will also be measured to confirm eligibility.

  2. Session 1 (approximately 40 minutes):

    Participants will complete a computer-based attention task that involves responding to specific visual cues on a screen. This task takes about 10 minutes. taVNS will then be delivered using electrodes placed on the left ear. For this session, participants will either receive active stimulation or sham stimulation, randomly assigned. The stimulation lasts 20 minutes. After the stimulation, participants will repeat the attention task to assess changes in performance.

  3. Break:

    Participants will have a short break between sessions, during which they can rest or engage in light activities.

  4. Session 2 (approximately 40 minutes):

The same sequence of procedures will be repeated, but participants will receive the alternate type of stimulation (active or sham) in this session. The order of active and sham stimulation is randomly assigned, and participants will not know which session is delivered first.

Throughout both sessions, participants' heart rate variability (HRV) will be monitored using a lightweight chest device. HRV provides insights into how the body responds to stimulation and helps evaluate taVNS's physiological effects.

研究类型

介入性

注册 (估计的)

30

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:Lane Witkowski Research Coordinator
  • 电话号码:206-419-1261
  • 邮箱:Lane.Witkowski@va.gov

学习地点

    • Texas
      • Houston、Texas、美国、77030
        • Michael E. DeBakey VA Medical Center
        • 首席研究员:
          • Ricardo Jorge, MD
        • 首席研究员:
          • Principal Investigator
        • 接触:
        • 接触:
        • 接触:

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

25年 至 64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:

  • Ages 25-64
  • Right-handedness
  • Veterans with a history of deployment to Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), Operation New Dawn (OND) or other post 9/11 war on terrorism
  • History of PTSD and/or depression
  • Military related mild traumatic brain injury
  • If taking psychotropic medication, demonstrate stability for 3 months
  • If taking stimulants, washout period of 12 hours

Exclusion Criteria:

  • History of neurological, cardiovascular, or pulmonary disease
  • Cardiac arrhythmia (all types)
  • Active suicidal ideation
  • Visible wounds on skin of the left ear
  • Medical implants such as cardiac defibrillators, pacemakers, or deep brain stimulators
  • Pregnancy
  • Completed taVNS in the past 4 weeks
  • Current substance use disorder (exception: mild cannabis use disorder allowed)
  • Current moderate or severe alcohol use disorder
  • Major cognitive disorder

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:治疗
  • 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
有源比较器:taVNS active stimulation

Participants will receive transcutaneous auricular vagus nerve stimulation (taVNS) using electrodes placed on the left ear. A low-level electrical current will be delivered to stimulate the vagus nerve. This stimulation is designed to activate brain areas involved in attention and memory.

taVNS does not require surgery or medication, offering a safe and accessible treatment option. Each participant undergoes both an active taVNS session and a sham (placebo) session. Sham stimulation mimics the sensory experience of taVNS but does not deliver electrical currents to the vagus nerve, ensuring blinding and providing robust comparisons. The study is completed in a single visit lasting 2.5 to 3 hours, minimizing participant burden.

Soterix Medical min-CT VNS device is used for non-invasive stimulation procedures and trials. It has blinding features such as single-blind for this study in which patients will either receive active or shame taVNS.

假比较器:Sham (Placebo) taVNS

Participants will undergo sham stimulation, where electrodes are placed on the left ear to mimic the experience of active taVNS. However, no electrical current will be delivered to the vagus nerve. This sham condition enables a direct comparison with active taVNS, ensuring that any observed changes in working memory and attention can be attributed to the taVNS intervention.

taVNS does not require surgery or medication, offering a safe and accessible treatment option. Each participant undergoes both an active taVNS session and a sham (placebo) session. Sham stimulation mimics the sensory experience of taVNS but does not deliver electrical currents to the vagus nerve, ensuring blinding and providing robust comparisons. The study is completed in a single visit lasting 2.5 to 3 hours, minimizing participant burden.

Soterix Medical min-CT VNS device is used for non-invasive stimulation procedures and trials. It has blinding features such as single-blind for this study in which patients will either receive active or shame taVNS.

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
Attention and working memory
大体时间:One day, one visit

Aim 1:

To evaluate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on sustained attention and working memory. Attention and memory performance will be assessed using the Gradual Onset Continuous Performance Task (gradCPT), a validated computerized test that measures the ability to sustain attention and respond selectively to relevant stimuli. This cognitive test measures sustained attention and inhibitory control. During the test, subjects view a continuous stream of gradually fading images of cities and mountains on a computer screen. They are instructed to press the space bar when they see a city (target stimulus) and withhold responses when they see a mountain (non-target stimulus). Key performance metrics which collectively assess attention and working memory in this test include mean reaction time (response speed), omission errors (failure to respond to targets), and commission errors (responses to non-targets).

One day, one visit

次要结果测量

结果测量
措施说明
大体时间
Heart-rate variability
大体时间:One day, one visit

Aim 2: To investigate the effects of taVNS on heart rate variability (HRV), an indicator of autonomic nervous system activity. HRV will be measured in milliseconds using a lightweight, wearable chest device capable of capturing continuous heart rate data. Key HRV metrics, including standard deviation of NN intervals (SDNN) and root mean square of successive differences (RMSSD), will be analyzed before, during, and after active and sham taVNS sessions to assess physiological responses to stimulation.

One day, one visit

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。

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。

一般刊物

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12月1日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2024年12月4日

首先提交符合 QC 标准的

2024年12月4日

首次发布 (实际的)

2024年12月9日

研究记录更新

最后更新发布 (实际的)

2026年10月5日

上次提交的符合 QC 标准的更新

2026年10月1日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

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

Individual participant data (IPD) will not be shared because this is an exploratory, feasibility trial designed to assess the potential effects of transcutaneous auricular vagus nerve stimulation (taVNS). As a pilot study, the primary goal is to evaluate the intervention's feasibility and gather preliminary data, rather than generate findings intended for broader generalization. To protect participant privacy and confidentiality, all data will be reported in aggregate form without identifying individual participants, in accordance with ethical guidelines and institutional policies.

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.

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