NCT07660250

Brief Summary

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Apr 2026May 2028

First Submitted

Initial submission to the registry

March 30, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

April 14, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

March 30, 2026

Last Update Submit

June 15, 2026

Conditions

Degenerative Cervical Myelopathy

Keywords

degenerative cervical myelopathymyelopathycervical myelopathydegenerative myelopathyvagus nervevagus nerve stimulationear stimulation

Outcome Measures

Primary Outcomes (1)

  • mJOA - Modified Japanese Orthopedics Association

    Measures neurological impairment in degenerative cervical myelopathy

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Neck Disability Index (NDI)

    through study completion, an average of 1 year

Study Arms (3)

Pre-Post Group (P-P)

EXPERIMENTAL

This group will undergo taVNS for up to 6 weeks before and for 3 months following surgery

Device: Vagus nerve stimulation (taVNS)

Post Group

EXPERIMENTAL

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)Device: Sham Stimulation

Sham Group

SHAM COMPARATOR

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

Interventions

Vagus nerve stimulation (taVNS)DEVICE

Vagus nerve stimulation - clip is attached to ear

Post GroupPre-Post Group (P-P)
Sham StimulationDEVICE

Clip will be attached to the ear, but no stimulation will be given.

Post GroupSham Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Diseases

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Wilson Z Ray, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Koester, BS

CONTACT

314-362-7368koesterl@wustl.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD - Principal Investigator

Study Record Dates

First Submitted

March 30, 2026

First Posted

June 22, 2026

Study Start

April 14, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
From enrollment with no specific end date.
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

Locations

US(1)