Recruiting

Transcutaneous Vagal Nerve Stimulation

Sponsor:

VA Office of Research and Development

Code:

NCT05517304

Conditions

Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

tcVNS

Sham

Study Details

Brief 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.

Conditions

Stress Disorders, Post-Traumatic

Study ID

NCT05517304

Start date

Oct 1, 2022

Status verified date

Feb, 2026

Completion date

Nov 10, 2027

Anticipated

Primary completion date

Jul 8, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

Subjects will be excluded with:

  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: tcVNS

Stimulation twice daily with transcutaneous Vagal Nerve Stimulation (tcVNS)

active comparator: Sham

Stimulation with sham

Interventions

tcVNS

Active stimulation with transcutaneous Vagal Nerve Stimulation (tcVNS)

Sham

Sham stimulation

Primary outcome measure

  • Change in PTSD symptoms [ Time Frame: Baseline to three months ]
  • Brain Activation [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Doug J Bremner, MD

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

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Doug J Bremner, MD

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

Principal Investigator:

Doug J Bremner, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Keywords

  • Stress Disorders, Post-Traumatic
  • PTSD
  • Vagus Nerve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-03-03.