Trial Outcomes & Findings for Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress (NCT NCT04935697)
NCT ID: NCT04935697
Last Updated: 2026-05-29
Results Overview
A composite endpoint of 90-day presentation to any emergency department and/or 90-day admission to any hospital.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
90 days
Results posted on
2026-05-29
Participant Flow
Participant milestones
| Measure |
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.
nVNS: 3x daily treatment of nVNS + SOC
SOC: Standard of care patient management.
|
Receiving Standard of Care
Patients will be managed according to the institutional best practices and SOC for TBI.
SOC: Standard of care patient management.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress
Baseline characteristics by cohort
| Measure |
Receiving Standard of Care
n=2 Participants
Patients will be managed according to the institutional best practices and SOC for TBI.
SOC: Standard of care patient management.
|
Total
n=3 Participants
Total of all reporting groups
|
Receiving Non-invasive Vagus Neurostimulation
n=1 Participants
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.
nVNS: 3x daily treatment of nVNS + SOC
SOC: Standard of care patient management.
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=51 Participants
|
|
Age, Continuous
|
29 years
n=14 Participants
|
41 years
n=65 Participants
|
41 years
n=51 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
0 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
1 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
1 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
1 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=51 Participants
|
|
Smoking Status
Smoker
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=51 Participants
|
|
Smoking Status
Non-smoker
|
2 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
1 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: 90 daysA composite endpoint of 90-day presentation to any emergency department and/or 90-day admission to any hospital.
Outcome measures
| Measure |
Receiving Non-invasive Vagus Neurostimulation
n=1 Participants
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.
nVNS: 3x daily treatment of nVNS + SOC
SOC: Standard of care patient management.
|
Receiving Standard of Care
n=2 Participants
Patients will be managed according to the institutional best practices and SOC for TBI.
SOC: Standard of care patient management.
|
|---|---|---|
|
All-Cause 90-Day Admission to Any Hospital or ED Encounter
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days from baselineOutcome measures
| Measure |
Receiving Non-invasive Vagus Neurostimulation
n=1 Participants
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.
nVNS: 3x daily treatment of nVNS + SOC
SOC: Standard of care patient management.
|
Receiving Standard of Care
n=2 Participants
Patients will be managed according to the institutional best practices and SOC for TBI.
SOC: Standard of care patient management.
|
|---|---|---|
|
Number of Participants With AEs/SAEs Up to 30 Days From Baseline
Adverse Event (AE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With AEs/SAEs Up to 30 Days From Baseline
Serious Adverse Event
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days from baselineOutcome measures
| Measure |
Receiving Non-invasive Vagus Neurostimulation
n=1 Participants
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.
nVNS: 3x daily treatment of nVNS + SOC
SOC: Standard of care patient management.
|
Receiving Standard of Care
n=2 Participants
Patients will be managed according to the institutional best practices and SOC for TBI.
SOC: Standard of care patient management.
|
|---|---|---|
|
Number of Participants With Abnormal Physical Examination by Day 30
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days from baselinePopulation: Not all outcomes could be analyzed. PaO2/FiO2 ratio data were not available for any patients. Temperature data were only available for a single patient in the arm treated according to standard of care. Blood pressure was assessed for all patients (at additional timepoints for patients who entered the study while hospitalized as compared to those who participated in an outpatient fashion).
Outcome measures
| Measure |
Receiving Non-invasive Vagus Neurostimulation
n=1 Participants
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.
nVNS: 3x daily treatment of nVNS + SOC
SOC: Standard of care patient management.
|
Receiving Standard of Care
n=2 Participants
Patients will be managed according to the institutional best practices and SOC for TBI.
SOC: Standard of care patient management.
|
|---|---|---|
|
Number of Participants With Abnormal Vital Signs by Day 30
Blood Pressure (Systolic / Diastolic; mmHg)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs by Day 30
Temperature (degrees F)
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days from baselinePopulation: Certain visits (during which the standard of care labs were done) were only held for the subgroup of patients that were hospitalized (n=1) at time of enrollment/randomization or for patients not hospitalized at enrollment/randomization but who presented for Visits 2 and 3 (which depended on the date of injury and date of consent). Note that hospitalization at the time of enrollment (and thus inpatient study participation) is unrelated to the primary study outcome of all-cause hospital admission.
Outcome measures
| Measure |
Receiving Non-invasive Vagus Neurostimulation
n=1 Participants
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.
nVNS: 3x daily treatment of nVNS + SOC
SOC: Standard of care patient management.
|
Receiving Standard of Care
n=2 Participants
Patients will be managed according to the institutional best practices and SOC for TBI.
SOC: Standard of care patient management.
|
|---|---|---|
|
Number of Participants With Abnormal Laboratory Results by Day 30
Ferritin
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Laboratory Results by Day 30
D-dimer
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Laboratory Results by Day 30
Hepatic Function Panel
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Results by Day 30
Complete Blood Count with Differential
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Results by Day 30
Comprehensive Metabolic Panel
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Laboratory Results by Day 30
C-reactive Protein
|
0 Participants
|
—
|
Adverse Events
Receiving Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Receiving Non-invasive Vagus Neurostimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Health Outcomes Researcher
Orthopaedic Institute, Allegheny Health Network
Phone: 412-359-4042
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place