Transcutaneous Vagus Nerve Stimulation for Attention and Memory

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-64
SponsorBaylor College of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

History of neurological, cardiovascular, or pulmonary disease

Cardiac arrhythmia (all types)

Active suicidal ideation

Visible wounds on skin of the left ear

Trial design

Treatments tested in this trial

  • Transcutaneous vagus nerve stimulation for attention in veterans with TBI
  • Soterix Medical Vagus Nerve Stimulation mini-CT

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Baylor College of Medicine

Lead sponsor

Michael E. DeBakey VA Medical Center

Collaborator