RecruitingNot Applicable

Vagal Nerve Stimulation in mTBI

United States100 participantsStarted 2021-02-25

Plain-language 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 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Veterans with mTBI and PTSD Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

CAPS

Timeframe: three months

insula

Timeframe: 10 minutes

HVLT-R % retention

Timeframe: baseline versus three months

Change in IL6 Concentration in Blood with Stress

Timeframe: Baseline to 120 minutes after stress

hippocampal activation

Timeframe: 10 minutes

Trial details

NCT IDNCT04437498

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-12-10

Contact for this trial

Doug J Bremner, MD

(404) 712-9569 James.Bremner@va.gov

View on ClinicalTrials.gov More PTSD trials