Recruiting

taVNS

Sponsor:

Baylor College of Medicine

Code:

NCT06723743

Conditions

Traumatic Brain Injury (TBI) Patients

Eligibility Criteria

Sex: All

Age: 25 - 64

Healthy Volunteers: Not accepted

Interventions

Transcutaneous vagus nerve stimulation for attention in veterans with TBI

Soterix Medical Vagus Nerve Stimulation mini-CT

Study Details

Brief 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.

Conditions

Traumatic Brain Injury (TBI) Patients

Study ID

NCT06723743

Start date

Aug, 2026

Status verified date

May, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 64

Healthy Volunteers: Not 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: taVNS active stimulation

Participants will receive transcutaneous auricular vagus nerve stimulation (taVNS) using electrodes placed on the left ear. A low-level electrical current will be delivered to stimulate the vagus nerve. This stimulation is designed to activate brain areas involved in attention and memory.

sham comparator: Sham (Placebo) taVNS

Participants will undergo sham stimulation, where electrodes are placed on the left ear to mimic the experience of active taVNS. However, no electrical current will be delivered to the vagus nerve. This sham condition enables a direct comparison with active taVNS, ensuring that any observed changes in working memory and attention can be attributed to the taVNS intervention.

Interventions

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.

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 outcome measure

  • Attention and working memory [ Time Frame: One day, one visit ]

Central Contacts and Locations

Central contacts

Lane Witkowski Research Coordinator

206-419-1261Lane.Witkowski@va.gov

Locations

Michael E. DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ricardo Jorge, MD

(713) 791-1414ricardo.jorge@bcm.edu

Principal Investigator:

Principal Investigator

Michael E. DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Lane Witkowski

206-419-1261lane.witkowski@bcm.edu

Audri Villalon

audriv@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • vagus nerve stimulation
  • attention
  • brain stimulation
  • PTSD
  • depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-05-07.