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NCT05390580 · ClinicalTrials.gov registry record · NA
Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT05390580: Completed NA study, sponsored by Washington University School of Medicine.
NCT05390580 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05390580, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a randomized open-label, with blinded outcome pilot study to evaluate the effect on inflammatory laboratory values and explore clinical outcomes in patients who present with ischemic strokes due to large vessel occlusions and are treated with either current accepted management, or accepted management in addition to transcutaneous auricular vagal nerve stimulation.
Primary Outcome
The primary endpoint was change in inflammatory biomarkers from baseline to day 5, with samples obtained every 1.5 days. Interleukin-1β was the main analyte. Repeated measures were analyzed longitudinally using mixed-effects models (FDA guidance), specifying subject as a random effect to account for multiple observations. This approach accommodated irregular timing, missing data, and time-varying covariates. Models included treatment, time since last known normal, and their interaction to test g
Interventions
- DEVICE transcutaneous auricular vagal nerve stimulation
- DEVICE Sham transcutaneous vagal nerve stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-09-26 |
| Est. Completion | 2024-08-23 |
| Phase | NA |
What the finished NCT05390580 record still lists
NCT05390580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which transcutaneous auricular vagal nerve stimulation is the first listed.
NCT05390580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05390580 about?
NCT05390580 is a clinical study titled "Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct". This is a randomized open-label, with blinded outcome pilot study to evaluate the effect on inflammatory laboratory values and explore clinical outcomes in patients who present with ischemic strokes due to large vessel occlusions and are treated with either current accepted management, or accepted m...
What is the current status of trial NCT05390580?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2022-09-26. Estimated completion is 2024-08-23.
What interventions are being tested in trial NCT05390580?
The interventions under investigation include: transcutaneous auricular vagal nerve stimulation (DEVICE), Sham transcutaneous vagal nerve stimulation (DEVICE).
Who is sponsoring clinical trial NCT05390580?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05390580's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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