A Pilot Study of Auricular Vagus Nerve Stimulation on Cardiovascular Biomarkers and Glycemic Homeostasis in Persons With Chronic Spinal Cord Injuries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Number of Treatment-related Adverse Events (AEs)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males and females
- •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
- •Pregnant or breastfeeding
- •Failure to satisfy inclusion criteria
- •Previous bariatric surgery
- •Active implantable devices (such as pacemakers)
- •Skin irritation or damage at the site (ear)
Arms & Interventions
aVNS followed by no aVNS in subjects with SCI
Auricular vagal nerve stimulation (aVNS) will be provided by a device that is placed around the ear. A low-voltage electrical signal will be given for 30 minutes. In the following visit, subjects will complete all study assessments without the aVNS. Participation will be up to 2 weeks.
Intervention: auricular nerve stimulation (aVNS) (Device)
aVNS followed by no aVNS in subjects with SCI
Auricular vagal nerve stimulation (aVNS) will be provided by a device that is placed around the ear. A low-voltage electrical signal will be given for 30 minutes. In the following visit, subjects will complete all study assessments without the aVNS. Participation will be up to 2 weeks.
Intervention: sham aVNS (Device)
no aVNS followed by aVNS in subjects with SCI
Subjects will complete all study assessments without the aVNS. In the following visit, Auricular vagal nerve stimulation (aVNS) will be provided by a device that is placed around the ear. A low-voltage electrical signal will be given for 30 minutes. Participation will be up to 2 weeks.
Intervention: auricular nerve stimulation (aVNS) (Device)
no aVNS followed by aVNS in subjects with SCI
Subjects will complete all study assessments without the aVNS. In the following visit, Auricular vagal nerve stimulation (aVNS) will be provided by a device that is placed around the ear. A low-voltage electrical signal will be given for 30 minutes. Participation will be up to 2 weeks.
Intervention: sham aVNS (Device)
Outcomes
Primary Outcomes
Number of Treatment-related Adverse Events (AEs)
Time Frame: 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
Time Frame: Up to 2 weeks
Safety will be determined by number of subjects that complete the two study, visits (in total, two weeks).
Secondary Outcomes
No secondary outcomes reported
Investigators
Patrick Daniel Ganzer
Assistant Professor
University of Miami