Recruiting

Transcutaneous Vagus Nerve Stimulation for Attention and Memory

ClinicalTrials.gov IDNCT06723743

PhaseNA

Enrollment30

SponsorBaylor College of Medicine

Age25 Years

SexALL

I'm interested View official listing

Conditions studied

Traumatic Brain Injury (TBI) Patients

About this study

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.

Interventions

Other: Transcutaneous 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.
Device: Soterix 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.

Primary outcomes

Attention and working memory (One day, one visit)

Eligibility information

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

Study locations

Michael E. DeBakey VA Medical Center, Houston, Texas 77030 United States
Michael E. DeBakey VA Medical Center, Houston, Texas 77030 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.