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 range
12 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a non-invasive vagal nerve stimulation device for people who had both a traumatic brain injury and acute respiratory distress — does my specific situation match those two conditions closely enough that the results of this study might be relevant to my care?
2Since this trial has already been completed and was measuring whether patients needed to come back to the hospital or emergency department within 90 days, has the data been published yet, and what did it show about whether nVNS made a difference compared to standard treatment?
3Because this was listed as 'Phase NA,' meaning it wasn't a standard drug-testing phase trial, what does that tell us about how much is still unknown about the safety and effectiveness of this type of nerve stimulation for TBI-related breathing problems?
4Given that this study focused on a very specific combination of traumatic brain injury and acute respiratory distress, would you consider nVNS a realistic option for me right now, or is there a standard treatment path I should try first before looking into this kind of approach?
5Are there other ongoing or recently completed trials studying nVNS or similar nerve stimulation approaches for ARDS or TBI that might be worth exploring, since this one is already done and I may have missed the enrollment window?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
All-Cause 90-Day Admission to Any Hospital or ED Encounter
Timeframe: 90 days
Trial details
NCT IDNCT04935697
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
. 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