Vagus Nerve Stimulation for Myelopathy

Washington University School of Medicine36 enrolled

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Degenerative Cervical Myelopathy

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Washington University

St Louis, Missouri, United States

RECRUITING

Outcomes

Primary Outcomes

mJOA - Modified Japanese Orthopedics Association

Measures neurological impairment in degenerative cervical myelopathy

Time frame: through study completion, an average of 1 year

Secondary Outcomes

Neck Disability Index (NDI)

NDI measures activity limitations associated with neck pain

Time frame: through study completion, an average of 1 year

Central Contacts

Linda Koester, BS

CONTACT

314-362-7368 koesterl@wustl.edu

Data from ClinicalTrials.gov

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