Status:
RECRUITING
Vagal Nerve Stimulation in mTBI
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Atlanta VA Medical Center
Conditions:
PTSD
mTBI
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
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 con...
Detailed Description
This projects will assess the effects of non-invasive Vagal Nerve Stimulation (nVNS) on neurobiology and cognition in combat Veterans with mild Traumatic Brain Injury (mTBI) and co-morbid posttraumati...
Eligibility Criteria
Inclusion
- Veterans with mTBI and PTSD
Exclusion
- 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 abuse use disorder based on the SCID within the past 12 months
- current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, anorexia nervosa or bulimia, based on the SCID
- active suicidal ideation based on criteria outlined below
- a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
- active neuroleptic, opiate, or benzodiazepine treatment
- structural abnormality on brain MRI or CT
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 9 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04437498
Start Date
February 25 2021
End Date
July 9 2026
Last Update
October 24 2025
Active Locations (1)
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1
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004