The purpose of this research is to test if Auricular Vagal Nerve Stimulation (aVNS) is safe in persons with spinal cord injury (SCI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
The Spark Sparrow system stimulates the auricular branch of the Vagus nerve using a low-voltage electrical signal comprising a 1 Hz - 150 Hz biphasic square wave with a pulse width of 50s - 750s. Stimulation current is controlled with a maximum voltage of 95 V and 1-5 milliamperes (mA) output current. The device is positioned at the auricular branch of the Vagus nerve on the ear with the outer electrode in front of the ear and the inner electrode into the hollow area of the ear, just above the ear canal. Stimulation will occur for 30 minutes. Participation will last up to 2 weeks and requires 2 separate in-person visits. Each visit will be up to 3 hours.
The Spark Sparrow system device will be positioned at the auricular branch of the Vagus nerve on the ear with the outer electrode in front of the ear and the inner electrode into the hollow area of the ear, just above the ear canal. Subjects will wear the device for 30 minutes during which no stimulation will be emitted. Participation will last up to 2 weeks and requires 2 separate in-person visits. Each visit will be up to 3 hours.
University of Miami
Miami, Florida, United States
RECRUITINGNumber of Treatment-related Adverse Events (AEs)
Safety will be reported as the number of treatment-related AEs assessed by study PI or physician
Time frame: Up to 2 weeks
Number of subjects that complete the study
Safety will be determined by number of subjects that complete the two study, visits (in total, two weeks).
Time frame: Up to 2 weeks
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