Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03858985
The ClinicalTrials.gov registry entry for NCT03858985 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator) is the first listed.
NCT03858985 reports 0 study locations.
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.