IntroductionChildren with cyclic vomiting syndrome (CVS) frequently suffer from disabling abdominal pain and comorbidities that impair quality of life. A noninvasive, auricular percutaneous electrical nerve field stimulation (PENFS) device is shown to be effective for abdominal pain in children with disorders of gut–brain interaction. We aimed to determine the effects of PENFS on pain, common comorbidities, and quality of life in pediatric CVS.MethodsChildren aged 8–18 years with drug-refractory CVS were enrolled in a prospective, open-label study receiving 6 consecutive weeks of PENFS. Subjects completed the following surveys at baseline, during/after therapy (week 6), and at extended follow-up approximately 4–6 months later: Abdominal Pain Index (API), State-Trait Anxiety Inventory for Children (STAI-C), Pittsburgh Sleep Quality Index (PSQI), and Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Profile-37.ResultsThirty subjects were included. Median (interquartile range, IQR) age was 10.5 (8.5–15.5) years; 60% were female. Median API scores decreased from baseline to week 6 (p= 0.003) and to extended follow-up (p< 0.0001). State anxiety scores decreased from baseline to week 6 (p< 0.0001) and to extended follow-up (p< 0.0001). There were short-term improvements in sleep at 6 weeks (p= 0.031) but not at extended follow-up (p= 0.22). Quality of life measures of physical function, anxiety, fatigue, and pain interference improved short-term, while there were long-term benefits for anxiety. No serious side effects were reported.ConclusionsThis is the first study to demonstrate the efficacy of auricular neurostimulation using PENFS for pain and several disabling comorbidities in pediatric CVS. PENFS improves anxiety, sleep, and several aspects of quality of life with long-term benefits for anxiety.Clinical trial registration: ClinicalTrials.gov, identifier NCT03434652.