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Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Musculoskeletal Pain in Cerebral Palsy
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Summary
This randomized, double-blind, sham-controlled clinical trial will evaluate the safety and efficacy of a 30-day home-based transcutaneous auricular vagus nerve stimulation (taVNS) intervention in adults with cerebral palsy (CP) and chronic musculoskeletal pain. Participants will be randomized to receive either active taVNS targeting the auricular branch of the vagus nerve or sham stimulation delivered to the earlobe. The primary outcomes are changes in musculoskeletal pain severity and pain interference, as well as safety assessed through treatment-emergent adverse events. Exploratory outcomes include health-related quality of life, depression, fatigue, spasticity, systemic inflammatory biomarkers, and blinding success.
Official title: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for the Treatment of Chronic Musculoskeletal (MSK) Pain in Adults With Cerebral Palsy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2026-10-01
Completion Date
2029-05-31
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
Active Transcutaneous Auricular Vagus Nerve Stimulation
Stimulation will target the auricular branch of the vagus nerve by applying stimulation to the cymba conchae region of the ear using the tVNS R device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA (milliamps) until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expected range based on prior studies 1 - 3.2mA). Pulse width will be set at 100μs (microseconds) and frequency will be set at 25Hz (Hertz). Parameters will be set for the duration of the intervention consisting of 4 hours of daily stimulation for a period of 30 days.
Sham Transcutaneous Auricular Vagus Nerve Stimulation
Stimulation will target the ear lobe using the tVNS R device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expected range based on prior studies 1 - 3.2mA). Pulse width will be set at 100μs and frequency will be set at 25Hz. Participants will perform 4 hours of stimulation per day for a period of 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.
Locations (1)
Parkwood Institute, St Joseph's Health Care London
London, Ontario, Canada