Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Musculoskeletal Pain in Cerebral Palsy

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 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.

Eligibility criteria

Qualifiers

Diagnosis of cerebral palsy

Age ≥18 years

Chronic musculoskeletal pain present for ≥1 year

Moderate or greater pain severity (≥4/10 on Numeric Pain Rating Scale)

Disqualifiers

Cardiovascular disease

Pacemaker or implanted electrical device

Cerebral shunt

Pregnancy or intent to become pregnant

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