Ear-based nerve stimulation for children with cyclic vomiting syndrome
Official title: Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome: A Randomized, Sham Controlled Trial
Run by Medical College of Wisconsin · NCT07465614 · Data updated 2026-11-12
This study will try a small ear nerve stimulator to reduce vomiting, nausea, and stomach pain in children who have cyclic vomiting syndrome.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 18 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Status | Recruiting |
| Started | February 11, 2026 |
| Main results expected | July 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT07465614 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children who meet the 2025 NASPGHAN criteria for pediatric cyclic vomiting syndrome, are English-speaking, have an intact external ear, at least two vomiting episodes in the prior six months, stable vital signs, and no implanted electrical device are ideal candidates.
✕Probably not a fit
Children with an alternative medical explanation for vomiting, significant developmental delay, active ear dermatologic disease, implanted electrical devices, or complex medical conditions are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children who meet diagnostic criteria for cyclic vomiting syndrome will receive either active or sham percutaneous electrical nerve field stimulation applied to the external ear. The device targets auricular branches of the vagus nerve to modulate gut-brain signaling thought to drive nausea, vomiting, and abdominal pain. Study procedures include device application at the clinic with follow-up to track frequency and severity of vomiting episodes, pain, and healthcare use. The trial excludes children with alternate medical explanations for vomiting, implanted electrical devices, or severe ear skin problems.
Why it matters
Potential benefit: If successful, the device could provide a safe, non-drug option that reduces vomiting episodes, pain, and emergency visits for affected children.
How similar studies have gone: Vagus nerve and auricular stimulation have shown promise in other conditions such as migraine and some nausea-related disorders, but robust evidence specifically in pediatric CVS is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Episodic vomiting that meet criteria for CVS based on the 2025 NASPGHAN guidelines for diagnosis of pediatric CVS * English-speaking * Lack of other explanation for vomiting * Intact external ear that is free of infection or severe dermatological conditions * Stable stable vital signs for their respective age * No currently implanted electrical device * Family able to accurately describe symptoms and number of vomiting episodes * At least 2 vomiting episodes during the 6 months prior to enrollment Exclusion Criteria: * Medically complex children or those who take a medication or suffer from another active disease that explain symptoms * Children or their parents who have significant developmental delay * Participants diagnosed with alternate conditions that explains their symptoms after undergoing medical workup per standard of care * Patients with findings of active disease such as intestinal malrotation, peptic ulcer disease, H.pylori gastritis, celiac disease, inflammatory bowel disease, allergic disorders, hydronephrosis, metabolic disorder or any other active chronic condition or medication that may cause of vomiting * Patients who are treated with a new drug affecting the central nervous system in the 4 weeks prior to enrollment * Pregnancy * Severe cardiopulmonary diseases such as chronic obstructive pulmonary disease (COPD) or coronary artery disease * Current chronic marijuana use defined as marijuana use \> 2 times per week over the last 6 months prior to study enrollment * Previously treated with a PENFS device
Where it's running
-
Children's Wisconsin
Milwaukee, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Gila Ginzburg, MD — Medical College of Wisconsin
- Study coordinator: Rachel Unteutsch, BS
- Email: runteutsch@mcw.edu
- Phone: 4142664844
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.