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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30 from baseline, day 60, day 90
Awards & highlights
Study Summary
This trial will test whether a device that stimulates the vagus nerve can help prevent worsening symptoms and death in patients with mild-to-moderate traumatic brain injury, when compared to standard care alone.
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.Check my eligibility
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.See study design
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 belowSelect...
I had a mild-to-moderate brain injury with a GCS score of 12 or more.
Select...
I was hospitalized for a mild or moderate head or neck injury.
Select...
I am between 18 and 80 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Days free of death
Secondary outcome measures
Adverse Events/Serious Adverse Events (AEs/SAEs)
All-cause mortality
Days free of invasive mechanical ventilation
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: nVNSExperimental 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.
Group II: SOC onlyExperimental Treatment1 Intervention
Patients will be managed according to the institutional best practices and SOC for TBI.
Find a Location
Who is running the clinical trial?
Chuck Noll FoundationUNKNOWN
ElectroCore INCIndustry Sponsor
30 Previous Clinical Trials
2,204 Total Patients Enrolled
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor
47 Previous Clinical Trials
13,033 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I am undergoing dialysis for chronic kidney failure.I need long-term oxygen or mechanical help to breathe due to severe COPD.Your Lung Injury Prediction Score (LIPS) is 2 or higher.I have been diagnosed with congestive heart failure.The patient is not expected to live for another day.I have burns covering 15% or more of my body.I am not pregnant, breastfeeding, or have a positive pregnancy test.My first nVNS treatment is scheduled within 24 hours of starting.I have moderate to severe difficulty breathing according to a specific medical standard.I had a mild-to-moderate brain injury with a GCS score of 12 or more.I was hospitalized for a mild or moderate head or neck injury.I was on a ventilator for more than 48 hours before my lung distress diagnosis.I have severe liver failure.I have been diagnosed with acute failure of the left side of my heart.I am between 18 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: nVNS
- Group 2: SOC only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial allow for participants under the age of twenty?
"This clinical trial is looking for participants aged 18 to 80. Those younger than 18 and older than 65 will find 568 studies and 1788 studies respectively that may suit their needs."
Answered by AI
What is the upper limit of individuals involved in this research endeavor?
"That is correct. According to clinicaltrials.gov, this medical trial started recruiting participants on August 4th 2021 and was most recently updated on February 21st 2022. A total of 46 candidates need to be recruited from a single center."
Answered by AI
Is there an opportunity to join this medical experiment?
"This clinical trial is seeking 46 individuals between 18 and 80 years old who are affected by acute lung injury, provided they satisfy the following criteria: Patient age must be within the range of 18-80; patient has experienced mild to moderate traumatic brain injury; not on mechanical ventilation; GCS sum score no less than 12; LIPS rating higher or equal 2; nVNS treatment administered in 24 hours after intake. Additionally, a written informed consent form needs to be signed off by either the participant themselves or their legal representative."
Answered by AI
Is this research initiative currently recruiting new participants?
"Affirmative. Clinicaltrials.gov reveals that, since its inception on August 4th 2021, this clinical trial is actively recruiting for 46 patients from a single medical centre. Its most recent update was on February 21st 2022."
Answered by AI
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