Vagus Nerve Stimulation for Myelopathy
Purpose
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)
Condition
- Degenerative Cervical Myelopathy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Washington University
St Louis, Missouri 63110
St Louis, Missouri 63110
More Details
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine