RECRUITING

Transcutaneous Vagus Nerve Stimulation for Attention and Memory

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-10
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06723743

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 25-64
  2. * Right-handedness
  3. * 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
  4. * History of PTSD and/or depression
  5. * Military related mild traumatic brain injury
  6. * If taking psychotropic medication, demonstrate stability for 3 months
  7. * If taking stimulants, washout period of 12 hours
  1. * History of neurological, cardiovascular, or pulmonary disease
  2. * Cardiac arrhythmia (all types)
  3. * Active suicidal ideation
  4. * Visible wounds on skin of the left ear
  5. * Medical implants such as cardiac defibrillators, pacemakers, or deep brain stimulators
  6. * Pregnancy
  7. * Completed taVNS in the past 4 weeks
  8. * Current substance use disorder (exception: mild cannabis use disorder allowed)
  9. * Current moderate or severe alcohol use disorder
  10. * Major cognitive disorder

Contacts and Locations

Study Contact

Lane Witkowski Research Coordinator
CONTACT
206-419-1261
Lane.Witkowski@va.gov

Study Locations (Sites)

Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
United States
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-10
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Traumatic Brain Injury (TBI) Patients