RecruitingNot ApplicableNCT06723743

Transcutaneous Vagus Nerve Stimulation for Attention and Memory

Transcutaneous Auricular Vagus Nerve Stimulation Effects on Attention and Working Memory: A Pilot Study

Sponsor

Baylor College of Medicine

Enrollment

30 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Traumatic Brain Injury (TBI) Patients

Summary

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.

Eligibility

Min Age: 25 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether transcutaneous vagus nerve stimulation (tVNS) — a non-invasive device worn on the ear — can improve attention and memory in military veterans who experienced PTSD, depression, or mild traumatic brain injury (TBI) during deployment. **You may be eligible if...** - Age 25–64 - Right-handed - A veteran who deployed during Operation Iraqi Freedom, Operation Enduring Freedom, Operation New Dawn, or other post-9/11 conflicts - Have a history of PTSD and/or depression - Have a history of mild traumatic brain injury related to military service **You may NOT be eligible if...** - Have an implanted metal device (e.g., pacemaker, cochlear implant) that could be affected by electrical stimulation - Have active suicidal ideation or severe psychiatric instability - Have certain neurological conditions that would confound the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTranscutaneous vagus nerve stimulation for attention in veterans with TBI

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.

DEVICESoterix Medical Vagus Nerve Stimulation mini-CT

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.