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Auricular Neurostimulation for Children with Cyclic Vomiting Syndrome

This study is looking into a new way to help children aged 5 to 18 who have Cyclic Vomiting Syndrome (CVS). CVS causes severe, repeated episodes of nausea and vomiting. The study will test a device called auricular neurostimulation, which uses gentle electrical pulses near the ear to stimulate nerves. Some participants will receive the active device, while others will receive a sham (inactive) device. The main goal is to see if this treatment can reduce the burden of CVS, measured over six months after treatment ends. You might be able to join if you have CVS that meets specific guidelines, speak English, and don't have other reasons for vomiting or certain medical conditions.

Study design
This interventional study plans to enroll 120 participants. Participants will be randomly assigned to receive either an active or a sham device.
What's involved
Participants will wear a percutaneously placed device (meaning it goes through the skin) for 5 days a week for several consecutive weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for six months after the end of treatment to assess the burden of Cyclic Vomiting Syndrome.

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NCT07465614

A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome

Recruiting
NAAges 5–18InterventionalTreatment
Medical College of Wisconsin
~120 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:Active percutaneous electrical nerve field stimulationSham percutaneous electrical nerve field stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cyclic Vomiting Syndrome Burden Index
Measured over From enrollment (baseline) to 6 months after end of treatment

Conditions

Cyclic Vomiting Syndrome

Explore related trials

Cyclical Vomiting

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Gila Ginzburg, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

Rachel Unteutsch, BS
[email protected]
4142664844
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Cyclic Vomiting Syndrome Burden IndexFrom enrollment (baseline) to 6 months after end of treatment

    A 5-item survey assessing the frequency, duration and severity of CVS attacks with scores ranging from minimum 0 to maximum 25 and higher score indicating worse outcome.