Recruiting

Auricular Vagal Nerve Stimulation

Sponsor:

Alexander T. Yahanda

Code:

NCT07218133

Conditions

Spinal Fusion

Hyperglycemia

Postoperative Pain Management

Postoperative Care

Spine Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Auricular vagus nerve stimulation

Sham Auricular Vagus nerve Stimulation

Study Details

Brief 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.

Conditions

Spinal Fusion

Hyperglycemia

Postoperative Pain Management

Postoperative Care

Spine Disease

Study ID

NCT07218133

Start date

Oct 8, 2025

Status verified date

Sep, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Auricular vagal nerve stimulation

Participants will receive vagal nerve stimulation twice on the day of surgery (once preoperatively) and twice daily postoperatively for duration of hospitalization.

All patients will be fitted with the device via adhesive contacts to the left ear. Stimulation will occur for 20 minutes per session. The intervention will provide stimulation according to the following parameters: frequency 20 Hz, pulse width 250 µm, and fixed intensity of 0.5 milliampere. The amplitude of stimulation may be reduced if a patient complains of discomfort at the site of stimulation

sham comparator: Sham vagal nerve stimulation

Participants will have an auricular vagal nerve stimulator device applied in the same manner as the experimental arm, but they will not receive the actual stimulation.

Interventions

Auricular vagus nerve stimulation

Transcutaneous auricular vagal nerve stimulation

Sham Auricular Vagus nerve Stimulation

Transcutaneous auricular vagal nerve stimulator applied without utilizing stimulating current.

Primary outcome measure

  • Inflammatory cytokine levels [ Time Frame: 5-10 days (depending on hospital admission length) ]

Central Contacts and Locations

Central contacts

Alexander T Yahanda, MD, MPHS

3143690198ayahanda@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Alexander T Yahanda, MD, MPHS

2604946828ayahanda@wustl.edu

Principal Investigator:

Eric C Leuthardt, MD

More Information

Sponsor

Alexander T. Yahanda

Last update posted

Aug 18, 2026

Last verified

Sep, 2025

Keywords

  • spinal fusion
  • postoperative pain
  • glycemic control
  • inflammation
  • vagal nerve stimulation
  • postoperative complications
  • cytokine
  • spine surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alexander T. Yahanda on 2026-08-18.