Vagus Nerve Stimulation for Neuropathic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This pilot randomized, double-blind, sham-controlled clinical investigation will evaluate the feasibility and safety of a 30-day home-based transcutaneous auricular vagus nerve stimulation (taVNS) intervention in adults with spinal cord injury (SCI) and neuropathic pain. Participants will be randomized to receive either active taVNS targeting the auricular branch of the vagus nerve or sham taVNS delivered to the earlobe. Primary outcomes include feasibility, safety, adherence, acceptability, and blinding success. Exploratory outcomes include changes in neuropathic pain, systemic inflammatory biomarkers, vagal tone assessed via heart rate variability, and quality of life.
Are You a Good Fit for This Trial?
This trial is for adults (18+) with any type of spinal cord injury who currently have nerve pain. Participants must be on no medications or a stable dose of pain, anti-inflammatory, or depression meds for at least 6 weeks.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active or sham transcutaneous auricular vagus nerve stimulation for 4 hours per day over a 30-day home-based intervention period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Transcutaneous Auricular Vagus Nerve Stimulation
Trial Overview
The study tests whether using a device that stimulates the vagus nerve through the ear (taVNS) at home for 30 days can help reduce nerve pain after spinal cord injury. Some participants get real stimulation; others get a sham (inactive) version.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants receive active transcutaneous auricular vagus nerve stimulation delivered via the cymba conchae of the left ear using the using the tVNS R device (taVNS Technologies, Erlangen, Germany) for 4 hours per day for 30 days.
Stimulation will target the ear lobe using the tVNS R device (taVNS Technologies, Erlangen, Germany) for 4 hours per day for 30 days. Stimulation will be applied to the ear lobe in order to ensure participant feel the stimulation while avoiding activation of the vagus nerve.
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
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