RecruitingNot ApplicableNCT05517304

Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder


Sponsor

VA Office of Research and Development

Enrollment

80 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study effects the effects of transcutaneous cervical vagal nerve stimulation (tcVNS) or a sham control on brain, physiology, and PTSD symptoms in Veterans with posttraumatic stress disorder (PTSD). Veterans undergo brain imaging and physiological measures in conjunction with traumatic scripts before and after three months of twice daily treatment with tcVNS or sham stimulation at home.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a small device worn behind the ear that gently stimulates a nerve (transcutaneous vagal nerve stimulation, or tVNS) can reduce PTSD symptoms in veterans without using medication. **You may be eligible if...** - You are a veteran between 18 and 75 years old - You have been diagnosed with PTSD (based on DSM-5 criteria) **You may NOT be eligible if...** - You have a history of mild, moderate, or severe traumatic brain injury (TBI) - You are pregnant - You have a history of meningitis or other neurological conditions - You have a current alcohol or substance use disorder (within the past 12 months) - You have a history of schizophrenia, bipolar disorder, or an eating disorder - You have active suicidal thoughts with a plan - You are currently taking opiates or benzodiazepines (like Valium) - You have a serious heart, liver, kidney, or neurological illness 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

DEVICEtcVNS

Active stimulation with transcutaneous Vagal Nerve Stimulation (tcVNS)

DEVICESham

Sham stimulation


Locations(1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

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NCT05517304


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