N/A N=3 Randomized Treatment

Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress

Acute Respiratory Distress Syndrome · Acute Lung Injury · Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) · Traumatic Brain Injury

Bottom Line

View on ClinicalTrials.gov: NCT04935697 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: All-Cause 90-Day Admission to Any Hospital or ED Encounter — 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: nVNS (Device); SOC (Other)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Primary completion: Mar 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY All-Cause 90-Day Admission to Any Hospital or ED Encounter	0; 0	—
SECONDARY Number of Participants With AEs/SAEs Up to 30 Days From Baseline	0; 0; 0; 0	—
SECONDARY Number of Participants With Abnormal Physical Examination by Day 30	0; 1	—
SECONDARY Number of Participants With Abnormal Vital Signs by Day 30	0; 1; 0	—
SECONDARY Number of Participants With Abnormal Laboratory Results by Day 30	1; 1; 1; 2; 0; 0	—

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).

Eligibility Criteria

Inclusion Criteria

Patient is between 12-80 years, inclusive
Patient has been admitted to the hospital for mild-to-moderate TBI that is restricted to the head and/or neck region.
Patient is not on invasive mechanical ventilation
Patient has a mild-to-moderate TBI based on a non-resuscitated or post-resuscitated Glasgow Coma Scale (GCS) sum score of =>12
Patient has a Lung Injury Prediction Score (LIPS) of =>2
Administration of the first nVNS treatment must be planned to take place within 24 h of intake
A signed, written informed consent form from the patient or legally authorized representative

Exclusion Criteria

Patient has a diagnosis of moderate or greater grade of respiratory distress/ARDS according to the Berlin definition of ARDS: Partial pressure of oxygen (PaO2) /Fraction of Inspired Oxygen (FiO2) > 100 mmHg (>13.3 kPa) to ≤ 200 mmHg (≤ 26.6 kPa) with positive end-expiratory pressure (PEEP) ≥ 5 cmH2O)
Woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test
Patient simultaneously taking part in another clinical trial
Patient is not expected to survive for 24 hours
Patient has an underlying clinical condition where, in the opinion of the study physicians and the institutional health provider physician, it would be extremely unlikely that the patient would not progress to invasive mechanical ventilation within 48 hours or any other condition that might require immediate invasive mechanical ventilation (e.g. motor neuron disease, Duchenne muscular dystrophy, or rapidly-progressive interstitial pulmonary fibrosis)
Patient has severe chronic obstructive pulmonary disease (COPD) requiring long-term home oxygen therapy or mechanical ventilation (non-invasive ventilation or via tracheotomy) except for continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BIPAP) used solely for sleep-disorder breathing
Patient has congestive heart failure
Patient has acute left ventricular failure
Patient has liver failure (Child-Pugh grade C)
Patient is receiving renal dialysis therapy for chronic renal failure
Patient is receiving extracorporeal membrane oxygenation, high-frequency oscillatory ventilation (HFOV) or any form of extracorporeal lung support
Patient has had any form of mechanical ventilation (invasive or non-invasive, excluding CPAP alone) for longer than 48 h prior to the diagnosis of mild-to-moderate respiratory distress/ARDS
Patient has burns to ≥ 15% of their total body surface area

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04935697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.