Auricular Vagus Nerve Stimulation (aVNS) in Chronic Spinal Cord Injuries (SCI)

NARecruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

February 4, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Spinal Cord Injuries
Interventions
DEVICE

auricular nerve stimulation (aVNS)

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.

DEVICE

sham aVNS

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.

Trial Locations (1)

33136

RECRUITING

University of Miami, Miami

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

University of Miami

OTHER