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Transcutaneous Vagus Nerve Stimulation for Attention and Memory

RECRUITINGN/ASponsored by Baylor College of Medicine
Actively Recruiting
PhaseN/A
SponsorBaylor College of Medicine
Started2025-11
Est. completion2026-02
Eligibility
Age25 Years – 64 Years
Healthy vol.Accepted
Locations2 sites

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

Age: 25 Years – 64 YearsHealthy volunteers accepted
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

Conditions2

DepressionTraumatic Brain Injury (TBI) Patients

Locations2 sites

Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Ricardo Jorge, MD(713) 791-1414ricardo.jorge@bcm.edu
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Audri8323419697audrih@aol.com

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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