nVNS for Traumatic Brain Injury-Induced Acute Respiratory Distress

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Disqualifiers: Pregnancy, COPD, Heart failure, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a device that stimulates a nerve in the neck, along with usual medical care, to help patients with mild-to-moderate brain injuries. The goal is to prevent serious complications like severe inflammation and breathing problems.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the nVNS treatment differ from other treatments for traumatic brain injury-induced acute respiratory distress?

The nVNS treatment is unique because it is a non-invasive therapy that uses a device to stimulate the vagus nerve, which may help reduce inflammation and improve breathing. Unlike traditional mechanical ventilation, which requires a mask or helmet, nVNS is administered through a handheld device applied to the neck, offering a novel approach for managing respiratory distress without the need for invasive procedures. ^{1 2 3 4 5}

Research Team

Sarah Kimutis

Principal Investigator

Allegheny Health Network

Eligibility Criteria

This trial is for hospitalized patients aged 18-80 with mild-to-moderate traumatic brain injury (TBI) not on mechanical ventilation. They must have a Glasgow Coma Scale score of at least 12 and a Lung Injury Prediction Score of at least 2, indicating potential respiratory issues. Exclusions include severe lung or heart conditions, pregnancy, burns over a large body area, participation in another trial, and certain critical health statuses.

Inclusion Criteria

Your Lung Injury Prediction Score (LIPS) is 2 or higher.

My first nVNS treatment is scheduled within 24 hours of starting.

I had a mild-to-moderate brain injury with a GCS score of 12 or more.

Exclusion Criteria

Patient simultaneously taking part in another clinical trial

You have a medical condition that makes it very likely you will need a breathing machine within 48 hours, or have a condition that might require immediate use of a breathing machine.

I am on a special lung support machine.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive non-invasive vagus nerve stimulation (nVNS) three times daily along with standard of care for TBI

Up to 30 days

Daily in-hospital monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at Day 30, Day 60, and Day 90

Up to 95 days

1 visit (in-person) at the end of follow-up period

Treatment Details

Interventions

• nVNS (Vagus Nerve Stimulator)

Trial Overview The study tests non-invasive vagus nerve stimulation (nVNS) using the gammaCore Sapphire S device plus standard care against standard care alone to prevent worsening of TBI-induced respiratory distress. The goal is to avoid progression towards severe inflammation and the need for invasive breathing support within the first month after injury.

Participant Groups

Group I: Receiving Standard of Care Experimental Treatment 1 Intervention

Patients will be managed according to the institutional best practices and SOC for TBI.

Group II: Receiving Non-invasive vagus neurostimulation Experimental Treatment 2 Interventions

nVNS treatment will be applied three times daily. One treatment is defined as 2 consecutive stimulations: one, 2-minute stimulation on the side of the neck followed by a second, 2-minute stimulation on the same side of the neck. The treatment will be done 3 times per day (morning, mid-day and 1 hour before bed at night), every day, until patient is discharged from the hospital or requires mechanical ventilation. Patient will record the time they administered these treatments. If the patient is unable to do this, a research staff member who has been trained on the device can assist. Will also receive SOC for TBI.

Who Is Running the Clinical Trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Lead Sponsor

Trials

52

Recruited

13,000+

Chuck Noll Foundation

Collaborator

Trials

1

Recruited

50+

ElectroCore INC

Industry Sponsor

Trials

31

Recruited

2,200+

Findings from Research

In a study involving 10 immunocompromised patients with acute respiratory failure, the newly developed helmet for non-invasive ventilation (NIV) was well tolerated and led to improved oxygenation within the first 24 hours.

The helmet may provide a safer and more comfortable alternative to traditional endotracheal intubation and standard face masks, as 8 out of 10 patients were successfully weaned from NIV, despite two patients requiring intubation due to septic shock.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of non-invasive ventilation delivered via a newly developed helmet in immunosuppressed patients with acute respiratory failure. Rabitsch, W., Schellongowski, P., Köstler, WJ., et al.[2020]

Neurally adjusted ventilatory assist (NAVA) with neurally controlled pressure support (PSN) significantly improved patient comfort during noninvasive ventilation (NIV) compared to both pneumatically-triggered pressure support (PSP) and NAVA itself, as shown in a study involving 14 patients post-extubation.

PSN also enhanced patient-ventilator interaction and synchrony, with a lower rate of asynchrony compared to PSP, indicating that PSN may be a more effective option for delivering NIV through a facial mask.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New setting of neurally adjusted ventilatory assist for noninvasive ventilation by facial mask: a physiologic study. Longhini, F., Pan, C., Xie, J., et al.[2022]

Non-invasive mechanical ventilation (NIV) using a helmet may be a safer and more tolerable alternative to face masks for patients with acute respiratory failure, as indicated by better tolerance in six studies and lower intubation rates in three studies.

While NIV with a helmet showed similar oxygenation levels compared to face masks, it also presented potential issues such as CO₂ rebreathing and increased ventilator asynchrony, highlighting the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review: Helmet and non-invasive mechanical ventilation in critically ill patients. Esquinas Rodriguez, AM., Papadakos, PJ., Carron, M., et al.[2021]

The study found that 30% of patients with isolated severe traumatic brain injury (TBI) developed acute respiratory distress syndrome (ARDS) within the first 8 days, indicating a significant risk associated with this condition.

Factors such as the severity of head injury, male sex, and early transfusion of platelets were linked to a higher risk of ARDS, suggesting that early platelet transfusion could be a modifiable risk factor worth further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The acute respiratory distress syndrome following isolated severe traumatic brain injury. Hendrickson, CM., Howard, BM., Kornblith, LZ., et al.[2022]

Mechanical ventilation is crucial for patients with traumatic brain injuries exhibiting severe symptoms like high intracranial pressure and coma, as it can help manage life-threatening conditions.

In cases of acute respiratory distress syndrome (ARDS), mechanical ventilation is indicated when patients show significant hypoxia and reduced lung capacity, ensuring better oxygenation and respiratory support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Indications and diagnostic criteria for early ventilation of trauma patients]. Riemenschneider, VT., Junginger, W.[2020]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of non-invasive ventilation delivered via a newly developed helmet in immunosuppressed patients with acute respiratory failure. [2020]

2. England pubmed.ncbi.nlm.nih.gov

New setting of neurally adjusted ventilatory assist for noninvasive ventilation by facial mask: a physiologic study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Clinical review: Helmet and non-invasive mechanical ventilation in critically ill patients. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The acute respiratory distress syndrome following isolated severe traumatic brain injury. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Indications and diagnostic criteria for early ventilation of trauma patients]. [2020]