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NCT04935697 · ClinicalTrials.gov registry record · NA
Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress
A NA study, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- Completed
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT04935697: Completed NA study, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
NCT04935697 is a NA study that has completed, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04935697, a NA study, has completed, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- COMPLETED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a prospective, randomized, two-arm, controlled 30-day investigational pilot trial using the gammaCore Sapphire S non-invasive vagus nerve stimulation (nVNS) device + standard of care (SOC) in newly-hospitalized patients with mild-to-moderate traumatic brain injury (TBI) to prevent the progression towards immunokine storms, systemic inflammatory response syndrome (SIRS), severe respiratory distress, and requirement for invasive mechanical ventilation, and death, when compared to SOC alone (the control arm).
Primary Outcome
A composite endpoint of 90-day presentation to any emergency department and/or 90-day admission to any hospital.
Interventions
- OTHER SOC
- DEVICE nVNS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-08-04 |
| Est. Completion | 2025-03-01 |
| Phase | NA |
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)34 total trials
What the finished NCT04935697 record still lists
NCT04935697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which SOC is the first listed.
NCT04935697 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04935697 about?
NCT04935697 is a clinical study titled "Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress". This is a prospective, randomized, two-arm, controlled 30-day investigational pilot trial using the gammaCore Sapphire S non-invasive vagus nerve stimulation (nVNS) device + standard of care (SOC) in newly-hospitalized patients with mild-to-moderate traumatic brain injury (TBI) to prevent the progre...
What is the current status of trial NCT04935697?
This trial is currently completed. It is a NA study. The enrollment target is 3 participants. The study started on 2021-08-04. Estimated completion is 2025-03-01.
What interventions are being tested in trial NCT04935697?
The interventions under investigation include: SOC (OTHER), nVNS (DEVICE).
Who is sponsoring clinical trial NCT04935697?
This trial is sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04935697's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 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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