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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Post Group (P-P) | Experimental | This group will undergo taVNS for up to 6 weeks before and for 3 months following surgery |
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| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus nerve stimulation (taVNS) | Device | Vagus nerve stimulation - clip is attached to ear |
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| Measure | Description | Time Frame |
|---|---|---|
| mJOA - Modified Japanese Orthopedics Association | Measures neurological impairment in degenerative cervical myelopathy | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index (NDI) | NDI measures activity limitations associated with neck pain | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
• Pregnancy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Koester, BS | Contact | 314-362-7368 | koesterl@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wilson Z Ray, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
We may share de-identified data with other researchers, including mJOA and NDI, along with the amount of stimulation that was administered.
From enrollment with no specific end date.
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
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2026 | Mar 30, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| Sham Stimulation | Device | Clip will be attached to the ear, but no stimulation will be given. |
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