Recruiting

taVNS

Sponsor:

Washington University School of Medicine

Code:

NCT07660250

Conditions

Degenerative Cervical Myelopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Vagus nerve stimulation (taVNS)

Sham Stimulation

Study Details

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)

Conditions

Degenerative Cervical Myelopathy

Study ID

NCT07660250

Start date

Apr 14, 2026

Status verified date

Jun, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pre-Post Group (P-P)

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

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

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.

Interventions

Vagus nerve stimulation (taVNS)

Vagus nerve stimulation - clip is attached to ear

Sham Stimulation

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

Primary outcome measure

  • mJOA - Modified Japanese Orthopedics Association [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Linda Koester, BS

314-362-7368koesterl@wustl.edu

Locations

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Linda Z Koester, BS

314-362-7368koesterl@wustl.edu

Wilson Z Ray, MD

rayz@wustl.edu

Principal Investigator:

Wilson Z. Ray, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • degenerative cervical myelopathy
  • myelopathy
  • cervical myelopathy
  • degenerative myelopathy
  • vagus nerve
  • vagus nerve stimulation
  • ear stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-06-22.