Effect of Transcutaneous Electrical Auricular Stimulation of the Vagus Nerve in Kidney Transplant Recipients

NATerminatedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

January 13, 2020

Primary Completion Date

January 7, 2021

Study Completion Date

January 7, 2021

Conditions
Vagus Nerve Stimulation
Interventions
DEVICE

Transcutaneous electrical auricular vagus nerve stimulation (VNS)

Electrical auricular stimulation is accomplished using a Roscoe Medical TENS 7000 that delivers a programmable electrical current density, frequency, and pulse width. The TENS 7000 will be connected to ear clip (or hand held) electrodes to transcutaneously stimulate the cymba conchae of the ear to activate the auricular branch of the vagus nerve (diagram above), also known as Arnold's nerve, which provides sensory innervation to the skin surrounding the ear canal. Through a neural reflex arc, activation of this sensory nerve sends a neural signal to the brainstem that then activates the efferent vagus nerve through the nucleus of the solitary tract (NTS). This is a well-described and clinically accepted neuromodulatory pathway, as transcutaneous electrical auricular stimulation has been studied to treat seizures, similarly to how invasive electrical vagus nerve stimulation has been approved by the FDA for the past two decades for the same indication.

Trial Locations (1)

11030

Northwell Health, Manhasset

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Northwell Health

OTHER