Recruiting NCT07660250
Vagus Nerve Stimulation for Myelopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vagus nerve stimulation (taVNS), Sham Stimulation.
- Who it may be relevant to
- Registry conditions: Degenerative Cervical Myelopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Vagus Nerve Stimulation to Improve Post-operative Outcomes of Degenerative Cervical Myelopathy
Overview
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)
Interventions
- Device Vagus nerve stimulation (taVNS)
Vagus nerve stimulation - clip is attached to ear - Device Sham Stimulation
Clip will be attached to the ear, but no stimulation will be given.
Primary outcome measures
- mJOA - Modified Japanese Orthopedics Association [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (1)
- Neck Disability Index (NDI) [Time frame: through study completion, an average of 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Washington University — St Louis
Identifiers
NCT: NCT07660250 · VNS