Transcutaneous Vagus Nerve Stimulation for Attention and Memory
Recruiting · NCT06723743 · Interventional (participants receive a specific treatment) · Lead sponsor: Baylor College of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
2 locations listed across 1 US state.
- Michael E. DeBakey VA Medical Center - Houston, Texas, United States
- Michael E. DeBakey VA Medical Center - Houston, Texas, United States