Auricular Vagal Nerve Stimulation for Spinal Fusion Surgery

NCT ID: NCT07218133

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-08
• Study Completion Date: 2026-12-31

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.

Detailed Description

Long-segment spinal fusions are effective interventions to relieve pain, neurological compromise, or disability related to a variety of causes of advanced spinal degeneration or spinal deformity. Despite advancements in minimally invasive spine surgery, revision of prior instrumentation, correction of coronal or sagittal imbalance, bony decompression, and multilevel arthrodesis often must be performed via open surgery. While these procedures can produce excellent results with regards to postoperative alignment, neural decompression, and functional improvement, they are long and invasive cases requiring large incisions and extensive soft tissue dissection and osseous manipulation. As such, postoperative adverse events or complications are common (e.g., DVT/PE, wound healing problems, infection, nerve stretch injury, etc.). These patients almost universally experience significant postoperative pain, require postoperative rehabilitation, and are at high-risk for hospital readmissions. Moreover, the sterile trauma from long-segment spinal surgeries is a tremendous systemic inflammatory stimulus that yields downstream sequelae such as hyperglycemia, elevated inflammatory markers (e.g. cytokines), signs of microvascular ischemia, and other stress-related outcomes. Attempts to control this inflammation and reduce the adverse effects of these surgeries are lacking, particularly with respect to non-pharmacologic options.

Vagal nerve stimulation (VNS) is a promising emerging modality by which the body's systemic inflammatory response may be attenuated. Importantly, VNS may be successfully applied via noninvasive auricular stimulation. This technique has been trialed as non-pharmacologic pain control adjunct after multiple types of surgeries or painful medical events, but none as traumatic as long-segment spinal fusion. It also has been shown to yield substantial anti-inflammatory effects in numerous animal models. Furthermore, auricular VNS has been extensively studied at Washington University School of Medicine in multiple neurological conditions, including aneurysmal subarachnoid hemorrhage, acute ischemic stroke, and intraparenchymal hemorrhage. The use of noninvasive VNS devices has been shown to be an intervention that is safely administered and does not cause undue distress to patients. Given these promising aspects of VNS, Washington University's particular interest in this treatment modality, and the unmet postoperative care needs for long-segment spinal fusion patients, the investigators propose prospectively studying the effects of auricular VNS in a population of patients at Barnes-Jewish Hospital who have undergone long-segment fusion surgeries. The investigators hypothesize that perioperative VNS will mitigate the systemic inflammatory reaction in these patients as demonstrated by reduced inflammatory markers (both direct and indirect) and improved inflammatory-mediated clinical outcomes.

This study will be a randomized controlled trial assessing differences between accepted perioperative care plus auricular VNS (the intervention) as compared to accepted perioperative care plus a sham stimulus. The VNS device will be a noninvasive stimulator applied to the left ear to stimulate the auricular branch of the vagus nerve. All patients will be fitted with the device, and the sham stimulus will not receive the required therapeutic stimulation through the device. Patients will receive stimulation twice on the day of surgery followed by twice daily during the duration of their postoperative hospital admission. Relevant inflammatory cytokines, laboratory tests, pain scores, clinical outcomes, and imaging studies will be obtained for each patient. Post-hospital disposition, delayed adverse outcomes, and hospital readmissions will also be tracked after discharge.

Conditions

Spinal Fusion; Hyperglycemia; Postoperative Pain Management; Postoperative Care; Spine Disease; Neurologic Deficits; Neurological Disorder; Inflammation; Spine Condition; Spinal (Fusion) Surgery; Cytokine Levels; Spine Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Auricular vagus nerve stimulation

Intervention Type: DEVICE

Transcutaneous auricular vagal nerve stimulation

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.

Group Type: SHAM_COMPARATOR

Sham Auricular Vagus nerve Stimulation

Intervention Type: DEVICE

Transcutaneous auricular vagal nerve stimulator applied without utilizing stimulating current.

Interventions

Auricular vagus nerve stimulation

Transcutaneous auricular vagal nerve stimulation

Intervention Type: DEVICE

Sham Auricular Vagus nerve Stimulation

Transcutaneous auricular vagal nerve stimulator applied without utilizing stimulating current.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexander T. Yahanda

OTHER

Sponsor Role: lead

Responsible Party

Alexander T. Yahanda

Neurosurgery Resident

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexander T Yahanda, MD, MPHS

Role: CONTACT

ayahanda@wustl.edu

2604946828

Facility Contacts

Alexander T Yahanda, MD, MPHS

Role: primary

ayahanda@wustl.edu

2604946828

Other Identifiers

202407057SpineVNS

Identifier Type: -

Identifier Source: org_study_id