Non-surgical ear nerve stimulation to help attention and memory in veterans with TBI
Transcutaneous Auricular Vagus Nerve Stimulation Effects on Attention and Working Memory: A Pilot Study
This study will test whether gentle electrical stimulation of the ear (taVNS) can help post-9/11 veterans with mild traumatic brain injury and PTSD or depression improve attention and memory.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 25 Years to 64 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT06723743 on ClinicalTrials.gov |
What this trial studies
Participants receive non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) delivered through electrodes on the ear to target brain areas involved in attention and memory. The study uses a randomized crossover design in a single 2.5–3 hour visit where each participant experiences one active taVNS session and one sham (placebo-like) session so researchers can directly compare effects. Cognitive tasks measuring attention and memory are completed after each session, and heart rate variability (HRV) is recorded to track autonomic changes. Screening includes medical and psychiatric questionnaires, vital signs, and confirmation of eligibility before stimulation.
Who should consider this trial
Good fit: Ideal candidates are right-handed, post-9/11 veterans aged 25–64 with a history of military-related mild TBI and current PTSD and/or depression who are medically stable on any psychotropic medications.
Not a fit: Patients with major cognitive disorder, active moderate-to-severe alcohol or substance use disorder, significant cardiac or implanted electrical devices, visible wounds on the left ear, pregnancy, or uncontrolled medical conditions are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, taVNS could provide a non-surgical, low-risk option to improve attention and memory in veterans with mild TBI and co-occurring PTSD or depression.
How similar studies have performed: Small pilot studies of taVNS have shown promising but mixed effects on cognition and HRV, so the approach is supported by preliminary data but not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas and 1 other locations
- Michael E. DeBakey VA Medical Center — Houston, Texas, United States (Recruiting)
- Michael E. DeBakey VA Medical Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Lane Witkowski Research Coordinator
- Email: Lane.Witkowski@va.gov
- Phone: 206-419-1261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.