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NCT04437498 · ClinicalTrials.gov registry record · NA
Vagal Nerve Stimulation in mTBI
A NA study of PTSD and mTBI, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04437498: Recruiting NA study of PTSD and mTBI, sponsored by VA Office of Research and Development.
NCT04437498 is a NA study of PTSD and mTBI that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 100 participants, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04437498, a NA study of PTSD and mTBI, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) is a measure of PTSD symptoms with a range of 0-80 and higher score indicating more severe PTSD symptoms. The investigators will compare change from baseline to post treatment with active vagal nerve stimulation (VNS) or sham stimulation twice daily.
Interventions
- DEVICE sham stimulation
- DEVICE nVNS
Study Locations (1)
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-02-25 |
| Est. Completion | 2026-07-09 |
| Phase | NA |
What NCT04437498 shows while recruiting
NCT04437498 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which sham stimulation is the first listed.
NCT04437498 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04437498 about?
NCT04437498 is a clinical study titled "Vagal Nerve Stimulation in mTBI". 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 o...
What is the current status of trial NCT04437498?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-02-25. Estimated completion is 2026-07-09.
What conditions does trial NCT04437498 study?
This clinical trial studies the following conditions: PTSD, mTBI.
What interventions are being tested in trial NCT04437498?
The interventions under investigation include: sham stimulation (DEVICE), nVNS (DEVICE).
Who is sponsoring clinical trial NCT04437498?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04437498 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PTSD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04437498's enrollment target sits among peer trials
100 62nd of 154 higher than 89 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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