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Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID05517304

Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

Led by VA Office of Research and Development · Updated on 2026-03-03

80

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of transcutaneous cervical vagal nerve stimulation tcVNS compared to a sham control on brain function, physiological responses, and PTSD symptoms in Veterans diagnosed with posttraumatic stress disorder PTSD. The study uses brain imaging and physiological measures during exposure to traumatic scripts to understand how tcVNS might influence these factors. Participants are randomly assigned to receive either active tcVNS or sham stimulation using the GammaCore device. They will apply the stimulation twice daily at home for three months. The study includes an initial brain imaging session using High Resolution Positron Emission Tomography HR-PET during exposure to stressful scripts, followed by repeated measures after the treatment period. The device and data handling are securely managed under strict supervision. During the study, participants undergo brain scans, physiological assessments, and blood tests to measure inflammatory biomarkers and sympathetic nervous system function. Researchers track changes in PTSD symptoms from baseline to three months. Safety and adherence are monitored throughout the trial. The total participation period includes baseline evaluation and three months of twice daily home treatment with follow-up assessments.

CONDITIONS

Brief Title

Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Veterans aged 18 to 75 years
  • Diagnosis of posttraumatic stress disorder (PTSD) based on DSM-5 criteria
Not Eligible

You will not qualify if you...

  • History of mild traumatic brain injury (mTBI) based on VA Criteria
  • Moderate or greater traumatic brain injury
  • Positive pregnancy test
  • Meningitis or other neurological disorders
  • Alcohol or substance abuse disorder within the past 12 months
  • Current or lifetime history of schizophrenia, schizoaffective disorder, bipolar I disorder, anorexia nervosa, or bulimia
  • Active suicidal ideation with a plan
  • Serious medical or neurological illnesses that preclude participation
  • Active treatment with opiates or benzodiazepines
  • History of structural brain abnormalities on MRI or CT if performed previously

Research Team

D

Doug J Bremner, MD

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