What is the mechanism of action of this treatment?

Non-invasive vagus nerve stimulation (nVNS) works by delivering electrical impulses to the vagus nerve, which can modulate neural activity and reduce inflammation. This is particularly important for TBI patients as it may help prevent the progression of systemic inflammatory response syndrome (SIRS) and other complications such as severe respiratory distress. By targeting the vagus nerve, nVNS can potentially stabilize autonomic functions and improve overall outcomes in TBI patients. Other common treatments for TBI include pharmacologic interventions to manage symptoms and prevent secondary injury, as well as physical and cognitive rehabilitation to support recovery.

What side effects are associated with this type of intervention?

Non-invasive vagus nerve stimulation (nVNS) for traumatic brain injury (TBI) is generally well-tolerated with mild side effects. Common side effects include a warm sensation, redness, itching, tingling, and muscle spasms. More serious adverse events are rare. Other treatments for TBI, such as medications and physical rehabilitation, may have side effects like dizziness, fatigue, and headaches, but these vary widely depending on the specific treatment used.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of Traumatic Brain Injury (TBI) using non-invasive vagus nerve stimulation (nVNS) like the gammaCore Sapphire S device. However, nVNS has been explored in other neurological conditions, and its potential benefits in TBI are currently being investigated. Broadly, treatments for TBI have included various pharmacological and non-pharmacological approaches aimed at managing symptoms and preventing complications.

What other types of research exist?

Promising novel alternatives to gammaCore Sapphire S for TBI patients include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain and has shown potential in treating various neurological conditions. 2) Deep Brain Stimulation (DBS), which involves implanting electrodes in specific brain areas to modulate neural activity and has been explored for severe cases of TBI. 3) High-Frequency Spinal Cord Stimulation (SCS), which has been used for pain management and may offer benefits for TBI-related symptoms. These alternatives are being actively researched and may provide new options for TBI treatment in 2024.

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Vagus Nerve Stimulator

nVNS for Traumatic Brain Injury-Induced Acute Respiratory Distress

N/A

Recruiting

Led By Boyle Cheng, PhD

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 been admitted to the hospital for mild-to-moderate TBI that is restricted to the head and/or neck region

Must not have

Patient is receiving extracorporeal membrane oxygenation, high-frequency oscillatory ventilation (HFOV) or any form of extracorporeal lung support

Patient is receiving renal dialysis therapy for chronic renal failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30 from baseline, day 60, day 90

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, nVNS devices can typically cause discomfort at the site of application, headache, dizziness or changes in blood pressure. Standard care side effects depend on treatments used but may include medication reactions or complications from hospital interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I was hospitalized for a mild or moderate head or neck injury.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on a special lung support machine.

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I am undergoing dialysis for chronic kidney failure.

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I need long-term oxygen or mechanical help to breathe due to severe COPD.

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I have been diagnosed with congestive heart failure.

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I have burns covering 15% or more of my body.

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I am not pregnant, breastfeeding, or have a positive pregnancy test.

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I have moderate to severe difficulty breathing according to a specific medical standard.

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I have severe liver failure.

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I have been diagnosed with acute failure of the left side of my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30 from baseline, day 60, day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 30 from baseline, day 60, day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 from baseline, day 60, day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Days free of death

Days free of invasive mechanical ventilation

Secondary study objectives

Adverse Events/Serious Adverse Events (AEs/SAEs)

All-cause mortality

Days free of organ failure

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Receiving Standard of CareExperimental Treatment1 Intervention

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

Group II: Receiving Non-invasive vagus neurostimulationExperimental Treatment2 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.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Non-invasive vagus nerve stimulation (nVNS) works by delivering electrical impulses to the vagus nerve, which can modulate neural activity and reduce inflammation. This is particularly important for TBI patients as it may help prevent the progression of systemic inflammatory response syndrome (SIRS) and other complications such as severe respiratory distress. By targeting the vagus nerve, nVNS can potentially stabilize autonomic functions and improve overall outcomes in TBI patients. Other common treatments for TBI include pharmacologic interventions to manage symptoms and prevent secondary injury, as well as physical and cognitive rehabilitation to support recovery.

Evaluation of current post-concussion protocols.