An interventional study of Transcutaneous vagus nerve stimulation for attention in veterans with TBI and Soterix Medical Vagus Nerve Stimulation mini-CT in Traumatic Brain Injury (TBI) Patients, sponsored by Baylor College of Medicine. Not yet recruiting at 2 sites in United States. Open to participants aged 25 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
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:
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:
The findings will help determine whether taVNS could be an effective treatment for improving attention and memory in veterans with TBI.
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:
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.
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.
Break:
Participants will have a short break between sessions, during which they can rest or engage in light activities.
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.
1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.
This study's planned enrollment of 30 is below the median of 56 across 1,133 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
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Exclusion Criteria:
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.
Other: Transcutaneous vagus nerve stimulation for attention in veterans with TBI · Device: Soterix Medical Vagus Nerve Stimulation mini-CT
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.
Other: Transcutaneous vagus nerve stimulation for attention in veterans with TBI · Device: Soterix Medical Vagus Nerve Stimulation mini-CT
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.
Attention and working memory
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).
Time frame: One day, one visit
Heart-rate variability
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.
Time frame: One day, one visit
Plan to share: No — 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Baylor College of Medicine