Degenerative Cervical MyelopathyNCT07660250
Vagus Nerve Stimulation for Myelopathy
A study testing Vagus nerve stimulation (taVNS) in people with Degenerative Cervical Myelopathy, run by Washington University School of Medicine at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Degenerative Cervical Myelopathy
- What is being tested?
- Vagus nerve stimulation (taVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Moderate or severe degenerative cervical myelopathy according to the mJOA
- Decompression surgery planned
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University
St Louis, Missouri, 63110
Linda Z Koester, BS, 314-362-7368, koesterl@wustl.edu
Wilson Z Ray, MD, rayz@wustl.edu
About this study
Official title: 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)
- Conditions
- Degenerative Cervical Myelopathy
- Being tested
- Vagus nerve stimulation (taVNS), Sham Stimulation
- Keywords
- degenerative cervical myelopathy, myelopathy, cervical myelopathy, degenerative myelopathy, vagus nerve, vagus nerve stimulation, ear stimulation
- Medical subject headings
- Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve stimulation (taVNS)Device
Vagus nerve stimulation - clip is attached to ear
Sham StimulationDevice
Clip will be attached to the ear, but no stimulation will be given.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Post Group (P-P) | Experimental | This group will undergo taVNS for up to 6 weeks before and for 3 months following surgery Receives: 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 Receives: 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. Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mJOA - Modified Japanese Orthopedics Association
Measures neurological impairment in degenerative cervical myelopathy
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Neck Disability Index (NDI)
NDI measures activity limitations associated with neck pain
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start14 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Cervical MyelopathyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilson Z. Ray, Washington University School of Medicine
- Investigators
- Wilson Z Ray, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660250
- Sponsor's protocol ID
- VNS
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We may share de-identified data with other researchers, including mJOA and NDI, along with the amount of stimulation that was administered.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagus Nerve Stimulation to Improve Post-operative Outcomes of Degenerative Cervical Myelopathy
- ClinicalTrials.gov ID
- NCT07660250
- Acronym / sponsor ID
- VNS
- Conditions
- Degenerative Cervical Myelopathy
- Keywords
- degenerative cervical myelopathy, myelopathy, cervical myelopathy, degenerative myelopathy, vagus nerve, vagus nerve stimulation, ear stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-Post Group (P-P) | Experimental | Device: Vagus nerve stimulation (taVNS)This group will undergo taVNS for up to 6 weeks before and for 3 months following surgery |
| Post Group | Experimental | Device: Vagus nerve stimulation (taVNS), Device: Sham StimulationThis group will undergo sham stimulation for up to 6 weeks before surgery. They will receive taVNS for 3 months after surgery |
| Sham Group | Sham comparator | Device: Sham StimulationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Moderate or severe degenerative cervical myelopathy according to the mJOA
- Decompression surgery planned
Key exclusion criteria (7 listed)
- • Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus nerve stimulation (taVNS)Vagus nerve stimulation - clip is attached to ear | Device | Post Group, Pre-Post Group (P-P) |
| Sham StimulationClip will be attached to the ear, but no stimulation will be given. | Device | Post Group, Sham Group |
Primary outcome
mJOA - Modified Japanese Orthopedics Association
Time frame: through study completion, an average of 1 year
Measures neurological impairment in degenerative cervical myelopathy
1 secondary outcome
Neck Disability Index (NDI)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. We may share de-identified data with other researchers, including mJOA and NDI, along with the amount of stimulation that was administered.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wilson Z Ray, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus nerve stimulation (taVNS) in people with Degenerative Cervical Myelopathy, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Koester, BS (314-362-7368, koesterl@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mJOA - Modified Japanese Orthopedics Association (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.