RECRUITING

Vagal Nerve Stimulation in mTBI

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

Mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) are important conditions for the Veterans Administration (VA) that frequently occur together in combat Veterans from the conflicts in Afghanistan and Iraq. In many Veterans these become chronic, raising the risk the burden of neurotrauma can worsen over time. This study will examine a new intervention called non-invasive Vagal Nerve Stimulation (nVNS) and its effects on memory and symptoms of PTSD and mTBI as well as brain and physiology in Veterans with mTBI and PTSD.

Official Title

Non-Invasive Vagal Nerve Stimulation in Veterans With Mild Traumatic Brain Injury (mTBI)

Quick Facts

Study Start:2021-02-25
Study Completion:2026-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04437498

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:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veterans with mTBI and PTSD
  1. * amnesia for the inciting event lasted longer than 24 hours
  2. * Glasgow Coma Scale Score after 30 minutes was less than 13
  3. * loss of consciousness more than 30 minutes
  4. * positive pregnancy test
  5. * meningitis or other neurological disorder other than mTBI
  6. * alcohol or substance abuse use disorder based on the SCID within the past 12 months
  7. * current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, anorexia nervosa or bulimia, based on the SCID
  8. * active suicidal ideation based on criteria outlined below
  9. * a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
  10. * active neuroleptic, opiate, or benzodiazepine treatment
  11. * structural abnormality on brain MRI or CT

Contacts and Locations

Study Contact

Doug J Bremner, MD
CONTACT
(404) 712-9569
James.Bremner@va.gov
Anna Woodbury, MD
CONTACT
(404) 321-6111
Anna.Woodbury@va.gov

Principal Investigator

Doug J Bremner, MD
PRINCIPAL_INVESTIGATOR
Atlanta VA Medical and Rehab Center, Decatur, GA

Study Locations (Sites)

Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Doug J Bremner, MD, PRINCIPAL_INVESTIGATOR, Atlanta VA Medical and Rehab Center, Decatur, GA

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 Date2021-02-25
Study Completion Date2026-01-15

Study Record Updates

Study Start Date2021-02-25
Study Completion Date2026-01-15

Terms related to this study

Keywords Provided by Researchers

  • vagus nerve
  • stress disorders, posttraumatic
  • traumatic brain injury
  • memory
  • hippocampus
  • emission tomography

Additional Relevant MeSH Terms

  • PTSD
  • mTBI