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NCT03858985 · ClinicalTrials.gov registry record · Phase 1
Vagal Nerve Stimulation to Probe Inflammation and Brain in Post-traumatic Stress
A Phase 1 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
NCT03858985: Completed Phase 1 study, sponsored by VA Office of Research and Development.
NCT03858985 is a Phase 1 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 88 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03858985, a Phase 1 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
Study Summary
The proposal aims to determine if non-invasive vagus nerve stimulation(nVNS) will alter: 1) the peripheral inflammatory biomarker profile, 2) the neural correlates of change in pain stimuli and 3) PTSD symptom severity and 4) life quality and function in Veterans with PTSD. The planned inflammatory biomarker and neuroimaging results can 1) promote knowledge of inflammatory and neurobiological mechanisms that contribute to pain in PTSD, and 2) advance the ability to provide targeted neuromodulation based interventions that support improved life quality and function for Veterans. These goals are consistent with the VA's mission to sponsor research examining variables related to pathogenesis, diagnosis, and(ultimately) treatment of neuropsychiatric disorders.
Primary Outcome
Examining fMRI derived hemodynamic response curve during rest and pain challenge carried out at baseline to week 1 of 1x daily treatment.
Interventions
- DEVICE Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator)
- DEVICE Cervical Transcutaneous Vagus Nerve Stimulation (Sham Comparator)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2019-02-04 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 1 |
What the finished NCT03858985 record still lists
NCT03858985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 2 interventions - of which Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator) is the first listed.
NCT03858985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03858985 about?
NCT03858985 is a clinical study titled "Vagal Nerve Stimulation to Probe Inflammation and Brain in Post-traumatic Stress". The proposal aims to determine if non-invasive vagus nerve stimulation(nVNS) will alter: 1) the peripheral inflammatory biomarker profile, 2) the neural correlates of change in pain stimuli and 3) PTSD symptom severity and 4) life quality and function in Veterans with PTSD. The planned inflammatory ...
What is the current status of trial NCT03858985?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2019-02-04. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT03858985?
The interventions under investigation include: Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator) (DEVICE), Cervical Transcutaneous Vagus Nerve Stimulation (Sham Comparator) (DEVICE).
Who is sponsoring clinical trial NCT03858985?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03858985's enrollment target sits among peer trials
88 650th of 2000 higher than 1,350 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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