Recruiting

Vagal Nerve Stimulation

Sponsor:

VA Office of Research and Development

Code:

NCT04437498

Conditions

PTSD

mTBI

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

sham stimulation

nVNS

Study Details

Brief 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.

Conditions

PTSD

mTBI

Study ID

NCT04437498

Start date

Feb 25, 2021

Status verified date

Jul, 2026

Completion date

Dec 10, 2026

Anticipated

Primary completion date

Dec 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Veterans with mTBI and PTSD

Exclusion Criteria:

  • amnesia for the inciting event lasted longer than 24 hours
  • Glasgow Coma Scale Score after 30 minutes was less than 13
  • loss of consciousness more than 30 minutes
  • positive pregnancy test
  • meningitis or other neurological disorder other than mTBI
  • alcohol or substance abuse use disorder based on the SCID within the past 12 months
  • current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, anorexia nervosa or bulimia, based on the SCID
  • active suicidal ideation based on criteria outlined below
  • a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
  • active neuroleptic, opiate, or benzodiazepine treatment
  • structural abnormality on brain MRI or CT

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: nVNS

non invasive vagal nerve stimulation

sham comparator: sham

sham stimulation

Interventions

sham stimulation

non invasive vagal nerve stimulation

nVNS

active vns stimulation

Primary outcome measure

  • CAPS [ Time Frame: three months ]
  • insula [ Time Frame: 10 minutes ]
  • HVLT-R % retention [ Time Frame: baseline versus three months ]
  • Change in IL6 Concentration in Blood with Stress [ Time Frame: Baseline to 120 minutes after stress ]
  • hippocampal activation [ Time Frame: 10 minutes ]

Central Contacts and Locations

Central contacts

Doug J Bremner, MD

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

Anna Woodbury, MD

(404) 321-6111Anna.Woodbury@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

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • vagus nerve
  • stress disorders, posttraumatic
  • traumatic brain injury
  • memory
  • hippocampus
  • emission tomography

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 2026-07-20.