Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Neuropathic Pain Following Spinal Cord Injury

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About 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.

Eligibility criteria

Qualifiers

SCI of any level or severity

18 years of age or older

current neuropathic pain

on no medications or on a stable prescribed dose (no change in prior 6-weeks) of anti-inflammatory, pain medications and/or depression medications

Disqualifiers

Prone to autonomic dysreflexia

presence of cardiovascular disease

pacemaker or other implanted electrical device

cerebral shunts

Trial design

Treatments tested in this trial

  • Active Transcutaneous Auricular Vagus Nerve Stimulation
  • Sham Transcutaneous Auricular Vagus Nerve Stimulation

Treatment groups

32 Participants
are divided into 2 treatment groups