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