RecruitingNot ApplicableNCT07218133
Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery
Sponsor
Alexander T. Yahanda
Enrollment
50 participants
Start Date
Oct 8, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study is a randomized controlled trial that will evaluate the effect of non-invasive auricular vagal nerve stimulation on inflammatory markers, glycemic control, postoperative pain, and inflammation-related clinical outcomes after long-segment spinal fusion surgeries when compared to current accepted management.
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- Long-segment spinal fusions (defined as constructs spanning at least L2-pelvis for thoracolumbar fusions or C2-T2 for cervical fusions)
- Ability to undergo a reliable neurologic examination and pain assessments
Exclusion Criteria7
- Patients \<18 years of age
- Shorter-segment spinal fusions than those described above
- Undergoing current active cancer therapy
- Undergoing treatment with immunosuppressive drugs
- Additional spinal surgery within past 6 months
- Sustained bradycardia or presence of pacemaker
- History of substance abuse
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Interventions
DEVICEAuricular vagus nerve stimulation
Transcutaneous auricular vagal nerve stimulation
DEVICESham Auricular Vagus nerve Stimulation
Transcutaneous auricular vagal nerve stimulator applied without utilizing stimulating current.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07218133
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