Testing auricular nerve stimulation for spinal cord injuries
A Pilot Study of Auricular Vagus Nerve Stimulation on Cardiovascular Biomarkers and Glycemic Homeostasis in Persons With Chronic Spinal Cord Injuries
This study is testing whether auricular nerve stimulation can help people with chronic spinal cord injuries feel better and improve their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06588608 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the safety of Auricular Vagal Nerve Stimulation (aVNS) in individuals with chronic spinal cord injuries. Participants will receive either active aVNS or a sham treatment to assess the effects on their condition. The study focuses on individuals with motor-complete and incomplete spinal cord injuries at specific levels of the spine. The goal is to determine if this intervention can provide therapeutic benefits for these patients.
Who should consider this trial
Good fit: Ideal candidates are males and females with chronic spinal cord injuries classified as motor-complete or incomplete at the C5-T10 levels.
Not a fit: Patients who are pregnant, breastfeeding, or have active implantable devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the quality of life for patients with spinal cord injuries by providing a new therapeutic option.
How similar studies have performed: While the specific application of aVNS in spinal cord injuries is novel, similar approaches in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Patrick D Ganzer, PhD — University of Miami
- Study coordinator: Patricia Graham, MS, CCRC
- Email: pgraham1@med.miami.edu
- Phone: 3052435110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.