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Transcutaneous Vagus Nerve Stimulation for Attention and Memory

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 64 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Screening (40 minutes): Participants will begin by completing questionnaires about their medical history, memory concerns, alcohol and substance use, mood, and demographics."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether gentle electrical pulses through the ear can improve attention and memory in veterans with a mild brain injury from military service and depression, PTSD, or both. In one visit, each person gets both real and sham (placebo) stimulation. Researchers also measure changes in the time between heartbeats.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 25–64 years old.
  • You are right-handed.
  • You are a veteran who deployed for Operation Iraqi Freedom, Operation Enduring Freedom, Operation New Dawn, or another post-9/11 war on terrorism.
  • You have a history of depression, PTSD (posttraumatic stress disorder), or both.
  • You have had a mild traumatic brain injury from military service.
  • If you take medicine for mental health, your medicine use has been stable for 3 months.
  • If you take stimulant medicine, you must go without it for 12 hours.

Who can't join

  • You have a history of brain or nerve, heart or blood vessel, or lung disease, or any type of irregular heartbeat.
  • You are currently having thoughts of suicide.
  • You have visible skin wounds on your left ear.
  • You have an implanted medical device, such as a heart defibrillator, pacemaker, or deep brain stimulator.
  • You are pregnant.
  • You have had this type of ear nerve stimulation in the past 4 weeks.
  • You currently have a substance use disorder, though mild cannabis use disorder is allowed, or moderate or severe alcohol use disorder.
  • You have a major cognitive disorder—a condition that causes serious problems with memory or thinking.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

TX