Status:
RECRUITING
A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Cyclic Vomiting Syndrome
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief 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 seve...
Detailed Description
Cyclic vomiting syndrome (CVS) is a disorder of gut-brain interaction characterized by severe, stereotypical and disabling episodes of intense nausea and vomiting, lasting anywhere from 2 hours to 7 d...
Eligibility 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
Key Trial Info
Start Date :
February 11 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07465614
Start Date
February 11 2026
End Date
December 31 2028
Last Update
March 16 2026
Active Locations (1)
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1
Children's Wisconsin
Milwaukee, Wisconsin, United States, 53226