Vagus Nerve Stimulation for Cerebral Palsy
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
This trial is for adults (18+) with cerebral palsy who have had moderate or worse musculoskeletal pain (pain score 4/10 or higher) for at least a year, and whose pain medications haven't changed in the past 6 weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active taVNS or sham stimulation for 4 hours per day over a 30-day home-based protocol
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Transcutaneous Auricular Vagus Nerve Stimulation
Trial Overview
The study tests whether daily home use of a device that stimulates the vagus nerve through the ear (taVNS) can reduce chronic muscle and joint pain in people with cerebral palsy. Participants are randomly assigned to get either real stimulation or a sham version as a comparison.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants receive active transcutaneous auricular vagus nerve stimulation delivered via the cymba conchae of the left ear using the using the tVNS R device (taVNS Technologies, Erlangen, Germany) for 4 hours per day for 30 days.
Stimulation will target the ear lobe using the tVNS R device (taVNS Technologies, Erlangen, Germany) for 4 hours per day for 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
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