Actively Recruiting

Phase Not Applicable
Age: 25Years - 64Years
All Genders
ID06723743

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

Led by Baylor College of Medicine · Updated on 2026-05-07

30

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

Sponsors

B

Baylor College of Medicine

Lead Sponsor

M

Michael E. DeBakey VA Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to determine if transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive brain stimulation method, can improve attention and memory in veterans who have traumatic brain injury (TBI) along with depression and/or posttraumatic stress disorder (PTSD). The study also investigates whether taVNS affects heart rate variability, which reflects the body's response to stimulation. This pilot study uses a single-visit crossover design to compare active taVNS against a sham (placebo) stimulation. Participants will receive two sessions during one visit lasting approximately 2.5 to 3 hours. In one session, active taVNS is delivered through electrodes placed on the left ear, sending a gentle electrical current to stimulate the vagus nerve and target brain areas involved in attention and memory. In the other session, sham stimulation mimics the sensation of taVNS without delivering electrical current. The order of sessions is randomly assigned, and participants will complete attention tasks before and after each session. Heart rate variability is monitored throughout using a lightweight chest device. During the visit, participants undergo screening including questionnaires about medical history, mood, and substance use, plus vital signs measurement. They complete computer-based attention tasks and receive both active and sham stimulations with a break in between. Researchers measure changes in attention and working memory as the primary outcome, and heart rate variability as a secondary outcome. This study helps assess the potential of taVNS as a treatment to improve cognitive function in veterans with TBI and related conditions.

CONDITIONS

Brief Title

Transcutaneous Vagus Nerve Stimulation for Attention and Memory

Who Can Participate

Age: 25Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 25 to 64 years
  • Right-handed individuals
  • Veterans with deployment history in Operation Iraqi Freedom, Operation Enduring Freedom, Operation New Dawn, or other post-9/11 military service
  • History of PTSD and/or depression
  • Military-related mild traumatic brain injury
  • Stable psychotropic medication use for at least 3 months if applicable
  • If taking stimulants, a washout period of 12 hours is required
Not Eligible

You will not qualify if you...

  • History of neurological, cardiovascular, or pulmonary disease
  • Any type of cardiac arrhythmia
  • Active suicidal thoughts
  • Visible wounds on the skin of the left ear
  • Presence of medical implants such as cardiac defibrillators, pacemakers, or deep brain stimulators
  • Pregnancy
  • Completed taVNS treatment in the past 4 weeks
  • Current substance use disorder, except mild cannabis use disorder
  • Current moderate or severe alcohol use disorder
  • Major cognitive disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single visit lasting 2.5 to 3 hours

Participants complete a single study visit involving two sessions of transcutaneous auricular vagus nerve stimulation (taVNS), one active and one sham, to evaluate effects on attention and working memory.

1 visit (in-person) including two stimulation sessions

Trial Site Locations

Total: 2 locations

1

Michael E. DeBakey VA Medical Center

Houston, Texas, United States, 77030

Actively Recruiting

2

Michael E. DeBakey VA Medical Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

L

Lane Witkowski Research Coordinator

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Auricular Transcutaneous Vagus Nerve Stimulation Diminishes Alpha-Band-Related Inhibitory Gating Processes During Conflict Monitoring in Frontal Cortices.

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https://pubmed.ncbi.nlm.nih.gov/35137108