Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Musculoskeletal Pain in Cerebral Palsy
Not yet recruitingNot applicableNCT07585292
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Brief summary (from the registry)
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.
Study details
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for the Treatment of Chronic Musculoskeletal (MSK) Pain in Adults With Cerebral Palsy
- Conditions
- Cerebral Palsy (CP)
- Musculoskeletal Pain
- Interventions
- Device: Active Transcutaneous Auricular Vagus Nerve Stimulation
- Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Start date
- 2026-10-01
- Primary completion
- 2029-02-28
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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) * Stable pain and/or anti-inflammatory medication dosing for ≥6 weeks Exclusion Criteria: * Cardiovascular disease * Pacemaker or implanted electrical device * Cerebral shunt * Pregnancy or intent to become pregnant * Current infection or open wounds at electrode sites
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07585292