Vagus Nerve Stimulation for Myelopathy

June 15, 2026 updated by: Wilson Z. Ray, Washington University School of Medicine

Vagus Nerve Stimulation to Improve Post-operative Outcomes of Degenerative Cervical Myelopathy

The objective of this study is to generate preliminary data to establish the feasibility and effectiveness of transauricular vagus nerve stimulation (taVNS) to improve post-operative outcomes of moderate to severe degenerative cervical myelopathy (DCM)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Principal Investigator:
          • Wilson Z. Ray, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years of age or older
  • Moderate or severe degenerative cervical myelopathy according to the mJOA
  • Decompression surgery planned

Exclusion Criteria:

  • • Pregnancy

    • Electrically active implants (e.g. pacemaker)
    • Known diagnosis of amyotrophic lateral sclerosis, multiple sclerosis, rheumatoid arthritis, concomitant thoracic and/or lumbar stenosis, spine tumor, HIV-related myelopathy
    • Ongoing cancer therapy
    • Ongoing use of immunomodulating or suppressive medication
    • Sustained bradycardia with a heartrate <50 beats per minute for > 5 minutes following admission.
    • Prior cervical spine surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-Post Group (P-P)
This group will undergo taVNS for up to 6 weeks before and for 3 months following surgery
Device: Vagus nerve stimulation (taVNS)
Vagus nerve stimulation - clip is attached to ear
Experimental: Post Group
This group will undergo sham stimulation for up to 6 weeks before surgery. They will receive taVNS for 3 months after surgery
Device: Vagus nerve stimulation (taVNS)
Vagus nerve stimulation - clip is attached to ear
Device: Sham Stimulation
Clip will be attached to the ear, but no stimulation will be given.
Sham Comparator: Sham Group
This group will undergo sham stimulation for up to 6 weeks before surgery and for 3 months after surgery. The patients will not know they are not receiving stimulation.
Device: Sham Stimulation
Clip will be attached to the ear, but no stimulation will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mJOA - Modified Japanese Orthopedics Association
Time Frame: through study completion, an average of 1 year
Measures neurological impairment in degenerative cervical myelopathy
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index (NDI)
Time Frame: through study completion, an average of 1 year
NDI measures activity limitations associated with neck pain
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Wilson Z Ray, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VNS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We may share de-identified data with other researchers, including mJOA and NDI, along with the amount of stimulation that was administered.

IPD Sharing Time Frame

From enrollment with no specific end date.

IPD Sharing Access Criteria

Researchers will be other staff and faculty of Washington University Neurosurgery Dept. They will not have access to PHI. The data will be stored in REDCap and will not be accessible without permission. A username and password will be required, along with the permission

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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