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Transcutaneous Vagus Nerve Stimulation for Attention and Memory

Sponsored by Baylor College of Medicine

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.

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…

Where this study is enrolling

Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.