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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 64
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
Michael E. DeBakey VA Medical Center
RECRUITING
Houston
Michael E. DeBakey VA Medical Center
NOT_YET_RECRUITING
Houston
Contact Information
Primary
Lane Witkowski Research Coordinator
Lane.Witkowski@va.gov
206-419-1261
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Michael E. DeBakey VA Medical Center
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov