14
Participants
Start Date
October 31, 2016
Primary Completion Date
June 30, 2020
Study Completion Date
November 30, 2020
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.
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.
Hennepin County Medical Center, Minneapolis
Lead Sponsor
Collaborators (1)
ElectroCore INC
INDUSTRY
CentraCare
OTHER