Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Veterans with mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD)
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
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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
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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