Vagus Nerve Stimulation for Myelopathy
ConditionDegenerative Cervical Myelopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years of age or older
Moderate or severe degenerative cervical myelopathy according to the mJOA
Decompression surgery planned
Disqualifiers
• 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
Trial design
Design model
Parallel
Treatments tested in this trial
Vagus nerve stimulation (taVNS)
DeviceVagus nerve stimulation - clip is attached to ear
Sham Stimulation
DeviceClip will be attached to the ear, but no stimulation will be given.
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: Pre-Post Group (P-P)Experimental treatment 1 intervention
Group B: Post GroupExperimental treatment 2 interventions
Group C: Sham GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
mJOA - Modified Japanese Orthopedics Association
Measures neurological impairment in degenerative cervical myelopathy
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Neck Disability Index (NDI)
NDI measures activity limitations associated with neck pain
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov