Actively Recruiting
Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery
Led by Alexander T. Yahanda · Updated on 2026-02-20
50
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of non-invasive auricular vagal nerve stimulation (VNS) on inflammatory markers, blood sugar control, postoperative pain, and inflammation-related outcomes after long-segment spinal fusion surgeries. This randomized controlled trial compares the use of auricular VNS plus accepted perioperative care against accepted care plus a sham stimulus. The study aims to address the significant postoperative inflammation and complications common in these extensive spine surgeries, which currently lack effective non-drug treatments. Participants will be randomly assigned to receive either real auricular VNS or a sham device. The VNS device is applied to the left ear and delivers stimulation twice on the surgery day (once before surgery) and then twice daily during the hospital stay. Each stimulation session lasts 20 minutes with specific parameters for frequency and intensity, which can be adjusted for comfort. The sham group will have the device applied but will not receive active stimulation. During the 5 to 10 days of hospital admission, researchers will collect blood samples to measure inflammatory cytokines and other markers, monitor pain scores, blood glucose, heart rate, blood pressure, opioid use, and insulin needs. They will also track postoperative complications, hospital stay length, discharge disposition, and readmissions up to 60 days after surgery. These assessments aim to understand how VNS affects inflammation and recovery in patients undergoing these complex spinal procedures.
CONDITIONS
Brief Title
Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Undergoing long-segment spinal fusion surgery spanning at least L2 to pelvis for thoracolumbar fusions or C2 to T2 for cervical fusions
- Able to undergo reliable neurologic examination and pain assessments
You will not qualify if you...
- Patients younger than 18 years
- Spinal fusions shorter than the defined long-segment criteria
- Currently receiving active cancer therapy
- Under treatment with immunosuppressive drugs
- Additional spinal surgery within the past 6 months
- Sustained bradycardia or presence of pacemaker
- History of substance abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 10 days (depending on hospital admission length)
Participants undergo long-segment spinal fusion surgery and receive auricular vagus nerve stimulation or sham stimulation during their hospital stay to reduce postoperative inflammation.
Twice on the day of surgery and twice daily during hospitalization
Duration - 60 days postoperatively
Participants are monitored for hospital readmissions and delayed adverse outcomes after discharge.
Visits as needed to assess readmission and recovery
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
A
Alexander T Yahanda, MD, MPHS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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