Spinal Cord Injuries
Conditions
Brief summary
The purpose of this research is to test if Auricular Vagal Nerve Stimulation (aVNS) is safe in persons with spinal cord injury (SCI).
Interventions
DEVICEauricular 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.
DEVICEsham 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.
Sponsors
University of Miami
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females 2. Chronic (equal or greater to 1 year) motor-complete and incomplete SCI Abbreviated Injury Scale (AIS) of A or B at the C5-T10 levels
Exclusion criteria
1. Pregnant or breastfeeding 2. Prisoner 3. Failure to satisfy inclusion criteria 4. Previous bariatric surgery 5. Active implantable devices (such as pacemakers) 6. Skin irritation or damage at the site (ear)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-related Adverse Events (AEs) | Up to 2 weeks | Safety will be reported as the number of treatment-related AEs assessed by study PI or physician |
| Number of subjects that complete the study | Up to 2 weeks | Safety will be determined by number of subjects that complete the two study, visits (in total, two weeks). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPatrick D Ganzer, PhD
University of Miami
Outcome results
None listed