Actively Recruiting
A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
Led by Medical College of Wisconsin · Updated on 2026-03-16
120
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Episodic vomiting meeting 2025 NASPGHAN criteria for pediatric CVS
- English-speaking
- No other explanation for vomiting
- Intact external ear without infection or severe dermatologic conditions
- Stable vital signs for age
- No implanted electrical devices
- Family able to accurately describe symptoms and vomiting episodes
- At least 2 vomiting episodes in the 6 months before enrollment
You will not qualify if you...
- Medically complex children or those with medications or diseases explaining symptoms
- Significant developmental delay in child or parents
- Alternate diagnoses explaining symptoms after standard medical evaluation
- Active diseases such as intestinal malrotation, peptic ulcer, H. pylori gastritis, celiac disease, inflammatory bowel disease, allergic disorders, hydronephrosis, metabolic disorders, or other chronic conditions causing vomiting
- New central nervous system drug treatment within 4 weeks before enrollment
- Pregnancy
- Severe cardiopulmonary diseases like COPD or coronary artery disease
- Chronic marijuana use more than twice weekly in the last 6 months
- Previous treatment with a PENFS device
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
R
Rachel Unteutsch, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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