Vagus Nerve Stimulation to Treat Moderate Traumatic Brain Injury

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

June 30, 2020

Study Completion Date

November 30, 2020

Conditions
Traumatic Brain InjuryAcute Brain Injuries
Interventions
DEVICE

gammaCore active device

The nVNS therapy will be performed using the gammaCore-R (electroCore LLC, NJ), which is an external hand-held vagal nerve stimulator. The gammaCore-R produces a low voltage electric signal consisting of five 5000 Hz pulses that are repeated at a rate of 25 Hz. It allows for a 120 second stimulation session. The stimulation will occur twice daily, one time in the morning and one time in the evening. This should be done as close to 12 hours apart as possible and should occur twice daily for the entire 12 week study period.

DEVICE

gammaCore sham device

The sham device appears identical to the gammaCore but does not provide a frequency of stimulation powerful enough to stimulate either efferent or afferent fibers of the vagus nerve. However, it does supply a low frequency current which will cause a tingling of this skin to improve blinding of the patients.

Trial Locations (1)

55415

Hennepin County Medical Center, Minneapolis

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

ElectroCore INC

INDUSTRY

lead

CentraCare

OTHER

NCT02974959 - Vagus Nerve Stimulation to Treat Moderate Traumatic Brain Injury | Biotech Hunter | Biotech Hunter