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