Vagus nerve stimulation to help recovery after cervical spine decompression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores the feasibility and potential effectiveness of transauricular vagus nerve stimulation (taVNS) added to the standard care for adults with moderate to severe degenerative cervical myelopathy who are planning decompression surgery. Participants are randomized to receive taVNS or sham stimulation around the time of surgery to see if the approach improves postoperative outcomes. The trial aims to generate preliminary data on safety, tolerability, and signals of clinical benefit. Eligible participants are adults with moderate or severe DCM without certain comorbid conditions and who are undergoing decompression surgery at Washington University in St. Louis.

Why it matters

Who can join: the full rules

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

Where it's running

• Washington University
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Wilson Z Ray, MD — Washington University School of Medicine
• Study coordinator: Linda Koester, BS
• Email: koesterl@wustl.edu
• Phone: 314-362-7368

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.