Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
NCT04437498

Vagal Nerve Stimulation in mTBI

Led by VA Office of Research and Development · Updated on 2025-10-24

100

Participants Needed

1

Research Sites

280 weeks

Total Duration

On this page

Sponsors

V

VA Office of Research and Development

Lead Sponsor

A

Atlanta VA Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Vagal Nerve Stimulation in mTBI

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Veterans with mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD)
Not Eligible

You will not qualify if you...

  • Amnesia for the inciting event lasted longer than 24 hours
  • Glasgow Coma Scale Score after 30 minutes was less than 13
  • Loss of consciousness more than 30 minutes
  • Positive pregnancy test
  • Meningitis or other neurological disorder other than mTBI
  • Alcohol or substance use disorder based on SCID within the past 12 months
  • Current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, anorexia nervosa or bulimia based on SCID
  • Active suicidal ideation
  • History of serious medical or neurological illness such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
  • Active treatment with neuroleptic, opiate, or benzodiazepine medications
  • Structural abnormality on brain MRI or CT

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States, 30033-4004

Actively Recruiting

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Research Team

D

Doug J Bremner, MD

CONTACT

A

Anna Woodbury, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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