Transcutaneous Vagal Nerve Stimulation for PTSD in Veterans

This study is looking at how transcutaneous Vagal Nerve Stimulation (tcVNS) affects symptoms of Post-Traumatic Stress Disorder (PTSD) in Veterans. tcVNS is a device that delivers gentle electrical pulses to a nerve in your neck. You would receive either the active tcVNS device or a sham device (which looks and feels similar but doesn't deliver active treatment). Researchers will measure changes in your PTSD symptoms and brain activity over three months. To join, you must be a Veteran between 18 and 75 years old with a PTSD diagnosis. You cannot have a history of moderate or severe traumatic brain injury, certain neurological conditions, or substance abuse. The study's current status is unclear.

Study design
This interventional study plans to enroll 80 participants who will be randomly assigned to receive either active tcVNS or sham stimulation. It is a blinded study, meaning neither you nor the researchers will know which treatment you are receiving.
What's involved
You would undergo brain imaging and physiological tests before and after three months of using the tcVNS or sham device twice daily at home. You will also be exposed to stressful traumatic scripts during some assessments.
Compensation
Not stated in the trial record.
Follow-up
Your PTSD symptoms will be measured from the start of the study up to three months later.

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NCT05517304

Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

Recruiting
NAAges 18–75InterventionalTreatment
VA Office of Research and Development
~80 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:tcVNSSham

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in PTSD symptoms
Measured over Baseline to three months
+1 more outcome measured
Stress Disorders, Post-Traumatic
1 sites across 1 states
Georgia1
  • Doug J Bremner, MD · PRINCIPAL_INVESTIGATOR · Atlanta VA Medical and Rehab Center, Decatur, GA

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Eligibility criteria

Inclusion

Veterans between the ages of 18 and 75 will be included with a diagnosis of PTSD based on DSM-5 criteria

Exclusion

a history of mild traumatic brain injury (mTBI) based on VA Criteria
moderate or greater TBI
positive pregnancy test
meningitis or other neurological disorder
alcohol or substance abuse use disorder based on DSM-5 criteria within the past 12 months
current or lifetime history of schizophrenia, schizoaffective disorder, bipolar I disorder, anorexia nervosa or bulimia, based on DSM-5
active suicidal ideation with a plan
a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness that would preclude participation based on clinical judgment of the PI
active opiate or benzodiazepine treatment
history of structural abnormality on brain MRI or CT if one has been performed in the past
  • Change in PTSD symptomsBaseline to three months

    Change in PTSD symptoms measured with the Clinician Administered PTSD Scale (CAPS) and PTSD Checklist (PCL) in tcVNS versus sham conditions

  • Brain ActivationBaseline

    Change in brain activation in insula measured with PET in response to trauma scripts with VNS compared to sham