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New treatment option for Cyclic Vomiting Syndrome
Official title A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
ClinicalTrials.gov ID: NCT07465614
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 18
You may be able to join if
- 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
You likely can't join if
- 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...
- Patients who are treated with a new drug affecting the central nervous system in the 4 weeks prior to enrollment
- Pregnancy
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.