A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome: A Randomized, Sham Controlled Trial
Medical College of Wisconsin
120 participants
Feb 11, 2026
INTERVENTIONAL
Conditions
Summary
Cyclic vomiting syndrome (CVS) is a fairly common disorder characterized by relentless episodes of vomiting followed by return to baseline health.The majority of children with CVS have concurrent severe abdominal pain and migraine-features, causing significant disability during the attacks. There are very few non-drug treatment options for CVS. Many patients are treated with antidepressants that are often ineffective and may cause serious side effects. Emergency room visits and hospitalizations for patients with CVS is extremely high and the syndrome has an immense impact on quality of life. Safe and effective, non-pharmacological therapies for children with CVS are greatly needed. Nausea, vomiting and gastrointestinal pain is modulated by the vagus nerve, an important regulator of the autonomic nervous system. The vagus communicates signals between the gastrointestinal tract and the central nervous system. Many studies indicate that vagal nerve stimulation is effective for various pain and vomiting conditions. Recent studies show that vagus nerve signaling is impaired in children with CVS. Researchers have demonstrated safety and efficacy of auricular percutaneous electrical nerve field stimulation (PENFS) targeting the vagus nerve in a small study of children with CVS. The aim of the current study is to investigate the effects of non-invasive PENFS on CVS episode frequency, duration and severity compared to a sham device in a randomized clinical trial.
Eligibility
Inclusion Criteria8
- 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 Criteria9
- 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
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Interventions
Auricular vagus nerve stimulation using an percutaneously placed, active device that is worn for 5 days/week for several consecutive weeks
Auricular vagus nerve stimulation using a sham device that is percutaneously placed on the wear and worn for 5 days/week for several consecutive weeks
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07465614