NCT04437498 (VNS mTBI) is a NA clinical trial of sham stimulation in PTSD, sponsored by VA Office of Research and Development.

Who is sponsoring NCT04437498?

NCT04437498 is sponsored by VA Office of Research and Development.

What drugs are being tested in NCT04437498?

Interventions in NCT04437498: sham stimulation, nVNS.

What condition does NCT04437498 study?

NCT04437498 studies PTSD, mTBI.

Is NCT04437498 still recruiting?

NCT04437498 is currently recruiting now. Last updated 24 October 2025.

Last reviewed 2025-10-24 · How we verify

NCT04437498: VNS mTBI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Vagal Nerve Stimulation in mTBI

Recruiting now NA Last updated 24 October 2025

What this trial tests

NA trial testing sham stimulation in PTSD in 100 participants. Currently enrolling.

Timeline

25 February 2021

Primary endpoint
21 May 2026

9 July 2026

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	25 February 2021
Primary completion	21 May 2026
Estimated completion	9 July 2026
Sites	1 location across United States

Drugs / interventions tested

sham stimulation
nVNS

Conditions studied

PTSD — all drugs for PTSD →
mTBI — all drugs for mTBI →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 55, any sex, with PTSD or mTBI. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Traumatic brain injury and immunological outcomes: the double-edged killer.
Datta S, Lin F, Jones LD, Pingle SC, et al · · 2023 · cited 10× · PMID 37228857 · DOI 10.2144/fsoa-2023-0037

Verify or expand the search:

Other trials of sham stimulation

Trials testing the same drug.

NCT07230158 — Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease II (TRANSFORM-AD II) · NA · not yet recruiting
NCT07285525 — Accelerating Motor Recovery in Glioma Patients Using Postoperative nrTMS · NA · active not recruiting
NCT06641193 — Clinical Trail of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Upper Limb Bradykinesia in Par · NA · enrolling by invitation
NCT06147167 — Effects of Individualized iTBS on Upper Limb Function After Stroke · NA · not yet recruiting
NCT05817786 — Treatment of Upper Limb Chronic Neuropathic Pain by Electrical Stimulation of the Brachial Plexus Nerve Roots · NA · recruiting

Other recruiting trials for PTSD

Currently open trials in the same condition.

NCT07473505 — Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospect · recruiting
NCT07010757 — Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial · NA · recruiting
NCT07372586 — Behavioral Health Collaborative Care Model in an ICU Recovery Clinic · NA · recruiting
NCT07390786 — Behavioral Health Collaborative Care Model in Post-ICU Clinic Family Pilot · NA · recruiting
NCT07469098 — Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events · Phase 2 · recruiting

Other VA Office of Research and Development trials

Trials by the same sponsor.

NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04437498 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 24 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04437498.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing