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Ear nerve stimulator could tame Kids' vomiting episodes

NCT ID NCT07465614

Symptom relief Sponsor: Medical College of Wisconsin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a small device worn on the ear that stimulates the vagus nerve, which helps control nausea and vomiting. Researchers want to see if it can make cyclic vomiting episodes less frequent, shorter, and less severe in 120 children. Half the kids will get an active device, and half will get a sham (fake) device to see if the real one works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
percutaneous electrical nerve field stimulation (PENFS) device
What this could lead to
If it works, this could offer a safe, non-drug option to reduce the frequency and severity of vomiting episodes in children with cyclic vomiting syndrome.
What could go wrong
This is an early-stage trial with only 120 participants, and the sham control means the real benefit may be small. The device requires weekly wear and may not work for all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cyclic vomiting syndrome Familial cyclic vomiting syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cyclic vomiting syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

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