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).
Who can participate
Age range12 Years – 80 Years
SexALL
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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)
What they're measuring
1
Days free of invasive mechanical ventilation
Timeframe: 30 days from baseline
2
Days free of death
Timeframe: 30 days from baseline
Trial details
NCT IDNCT04935697
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
. 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