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

NCT ID: NCT04935697

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-04
• Study Completion Date: 2025-03-01

Brief 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).

Detailed Description

A pilot population of 46 individuals between 18-80 years of age inclusive, will be enrolled, with an in-trial monitoring period of up to 30 days following baseline measurements. Study subjects will remain in-trial until one of the following occurs: a) 30 days without any progression to respiratory distress requiring mechanical ventilation; b) requirement for mechanical ventilation prior to 30 days; or c) death prior to 30 days. In addition to the screening, a total of up to 5 additional in-trial events (depending on the time at discharge from hospitalization) plus one additional clinical site visit at the end of the follow-up period will comprise the study events schedule of this trial.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Receiving Non-invasive vagus neurostimulation

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.

Group Type: EXPERIMENTAL

nVNS

Intervention Type: DEVICE

3x daily treatment of nVNS + SOC

SOC

Intervention Type: OTHER

Standard of care patient management.

Receiving Standard of Care

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

Group Type: OTHER

SOC

Intervention Type: OTHER

Standard of care patient management.

Interventions

nVNS

3x daily treatment of nVNS + SOC

Intervention Type: DEVICE

SOC

Standard of care patient management.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ElectroCore INC

INDUSTRY

Sponsor Role: collaborator

Chuck Noll Foundation

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Edward Snell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Kimutis

Role: STUDY_DIRECTOR

Allegheny Health Network

Locations

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

nVNS for TBI-ALI/ARDS

Identifier Type: -

Identifier Source: org_study_id