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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Children's Wisconsin

Milwaukee, Wisconsin, United States, 53226