Non-invasive vagus nerve stimulation for patients with traumatic brain injury and respiratory distress
Non-invasive Vagal Neurostimulation (nVNS) to Mitigate Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress and Acute Lung Injury
This study is testing a non-invasive device to see if it can help people with mild-to-moderate traumatic brain injury avoid serious breathing problems while they are in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 12 Years to 80 Years |
| Sex | All |
| Sponsor | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04935697 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the use of a non-invasive vagus nerve stimulation device, gammaCore Sapphire S, in combination with standard care for newly hospitalized patients suffering from mild-to-moderate traumatic brain injury (TBI). The study aims to prevent the progression to severe respiratory distress and the need for mechanical ventilation over a 30-day monitoring period. A total of 46 participants aged 12 to 80 will be enrolled, with outcomes measured based on respiratory distress progression, mechanical ventilation requirements, and mortality. Participants will receive up to five in-trial assessments and one follow-up visit post-discharge.
Who should consider this trial
Good fit: Ideal candidates are hospitalized individuals aged 12 to 80 with mild-to-moderate TBI and a Lung Injury Prediction Score of 2 or higher.
Not a fit: Patients with moderate or greater respiratory distress or ARDS, as well as pregnant or lactating women, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for invasive mechanical ventilation and improve survival rates in patients with TBI-induced respiratory distress.
How similar studies have performed: While the use of vagus nerve stimulation is gaining interest, this specific application for TBI-induced respiratory distress is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient is between 12-80 years, inclusive 2. Patient has been admitted to the hospital for mild-to-moderate TBI that is restricted to the head and/or neck region. 3. Patient is not on invasive mechanical ventilation 4. Patient has a mild-to-moderate TBI based on a non-resuscitated or post-resuscitated Glasgow Coma Scale (GCS) sum score of =\>12 5. Patient has a Lung Injury Prediction Score (LIPS) of =\>2 6. Administration of the first nVNS treatment must be planned to take place within 24 h of intake 7. A signed, written informed consent form from the patient or legally authorized representative Exclusion Criteria: 1. 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) 2. Woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test 3. Patient simultaneously taking part in another clinical trial 4. Patient is not expected to survive for 24 hours 5. 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) 6. 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 7. Patient has congestive heart failure 8. Patient has acute left ventricular failure 9. Patient has liver failure (Child-Pugh grade C) 10. Patient is receiving renal dialysis therapy for chronic renal failure 11. Patient is receiving extracorporeal membrane oxygenation, high-frequency oscillatory ventilation (HFOV) or any form of extracorporeal lung support 12. 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 13. Patient has burns to ≥ 15% of their total body surface area
Where this trial is running
Pittsburgh, Pennsylvania
- AHN Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Mary Fetter
- Email: mary.fetter@ahn.org
- Phone: 412-359-8292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.