RecruitingNot ApplicableNCT04437498

Vagal Nerve Stimulation in mTBI

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


Sponsor

VA Office of Research and Development

Enrollment

100 participants

Start Date

Feb 25, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether non-invasive vagus nerve stimulation (a device placed on the neck) can improve symptoms of PTSD and mild traumatic brain injury (mTBI) in veterans. **You may be eligible if...** - You are a veteran - You have both a mild traumatic brain injury (mTBI) and PTSD **You may NOT be eligible if...** - You lost consciousness for more than 30 minutes during the injury - You had memory loss for more than 24 hours after the injury - Your consciousness level (GCS score) was below 13 after 30 minutes - You have a pacemaker or other implanted electronic device in your neck or chest - You are pregnant - You have meningitis or other active neurological conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEsham stimulation

non invasive vagal nerve stimulation

DEVICEnVNS

active vns stimulation


Locations(1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

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NCT04437498


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