Ear (auricular) vagus nerve stimulation to lower inflammation after long spinal fusion
Official title: Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery
Run by Washington University School of Medicine · NCT07218133 · Data updated 2026-11-12
This trial will test whether non-invasive ear-based vagus nerve stimulation can lower inflammation, improve blood sugar control, and reduce pain after long-segment spinal fusion surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | October 8, 2025 |
| Main results expected | January 2027 |
| Study ends | June 2027 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT07218133 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults having long-segment spinal fusions (constructs spanning at least L2-pelvis for thoracolumbar or C2-T2 for cervical) who can undergo reliable neurologic exams and pain assessments are ideal candidates.
✕Probably not a fit
Patients with shorter-segment fusions, age under 18, active cancer therapy, immunosuppressive treatment, recent additional spinal surgery, pacemaker or sustained bradycardia, or a history of substance abuse are unlikely to be eligible or receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, controlled trial comparing non-invasive trans-auricular vagus nerve stimulation versus a sham procedure in patients undergoing long-segment spinal fusion. Participants will receive perioperative auricular stimulation and researchers will monitor inflammatory markers (including cytokines), glycemic control, pain scores, and inflammation-related clinical outcomes such as wound complications and readmissions. The study focuses on extensive open fusion constructs (L2-pelvis or C2-T2) that generate large systemic inflammatory responses. Outcomes will be collected in the immediate postoperative period to determine whether this non-pharmacologic approach reduces physiologic stress and clinical complications.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative inflammation, lower hyperglycemia and pain, and potentially decrease complications and hospital readmissions after long spinal fusions.
How similar studies have gone: Vagal nerve stimulation has shown promising anti-inflammatory and pain-modulating effects in prior pilot and non-surgical studies, but its use specifically to improve outcomes after long-segment spinal fusion is novel and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Washington University School of Medicine
St Louis, Missouri, United States Recruiting
Study contacts
- Study coordinator: Alexander T Yahanda, MD, MPHS
- Email: ayahanda@wustl.edu
- Phone: 3143690198
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.