Auricular Neurostimulation Using PENFS for Children Ages 5 to 18 With Cyclic Vomiting Syndrome A Randomized, Sham-Controlled Study

What this Trial Is About

Cyclic vomiting syndrome CVS is a disorder mainly seen in children, characterized by repeated episodes of severe vomiting and abdominal pain often linked with migraine symptoms. This condition causes significant disability and greatly impacts quality of life, with many children requiring emergency care. Current treatments mainly involve antidepressants, which can have serious side effects and are often ineffective, highlighting the need for safer, non-drug therapies. The study aims to evaluate the effects of non-invasive auricular neurostimulation, specifically percutaneous electrical nerve field stimulation PENFS, on reducing CVS episode frequency, duration, and severity in children aged 5 to 18 years. Participants will be randomly assigned in a 21 ratio to receive either active or sham PENFS therapy. The active treatment involves auricular vagus nerve stimulation using a device worn on the outer ear for 5 consecutive days per week over 5 weeks. The sham group will use a similar device without active stimulation for the same duration. This randomized, sham-controlled design allows comparison of the effects of PENFS on CVS symptoms while maintaining blinding. During the study, children will be monitored for changes in the burden of CVS episodes from baseline to 6 months after treatment ends. Researchers will assess outcomes including episode frequency, duration, severity, and quality of life using validated scales. Follow-up will continue for 12 months after therapy completion, with regular evaluations of symptoms and functional disability. Safety will be monitored throughout, with adherence to treatment and symptom tracking recorded to understand PENFSs impact on this condition.

A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome