North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition 2025 guidelines for management of cyclic vomiting syndrome in children.
Katja Karrento, John M Rosen, Sally E Tarbell...
https://pubmed.ncbi.nlm.nih.gov/40223700Actively Recruiting
Phase Not Applicable
Age: 5Years - 18Years
All Genders
ID07465614
Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome: A Randomized, Sham Controlled Trial
Led by Medical College of Wisconsin ยท Updated on 2026-03-16
120
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cyclic vomiting syndrome (CVS) is a disorder mainly seen in children, characterized by repeated episodes of severe vomiting and abdominal pain often linked with migraine symptoms. This condition causes significant disability and greatly impacts quality of life, with many children requiring emergency care. Current treatments mainly involve antidepressants, which can have serious side effects and are often ineffective, highlighting the need for safer, non-drug therapies. The study aims to evaluate the effects of non-invasive auricular neurostimulation, specifically percutaneous electrical nerve field stimulation (PENFS), on reducing CVS episode frequency, duration, and severity in children aged 5 to 18 years. Participants will be randomly assigned in a 2:1 ratio to receive either active or sham PENFS therapy. The active treatment involves auricular vagus nerve stimulation using a device worn on the outer ear for 5 consecutive days per week over 5 weeks. The sham group will use a similar device without active stimulation for the same duration. This randomized, sham-controlled design allows comparison of the effects of PENFS on CVS symptoms while maintaining blinding. During the study, children will be monitored for changes in the burden of CVS episodes from baseline to 6 months after treatment ends. Researchers will assess outcomes including episode frequency, duration, severity, and quality of life using validated scales. Follow-up will continue for 12 months after therapy completion, with regular evaluations of symptoms and functional disability. Safety will be monitored throughout, with adherence to treatment and symptom tracking recorded to understand PENFS's impact on this condition.
CONDITIONS
Brief Title
A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
Who Can Participate
Age: 5Years - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 18 years
- Diagnosis of cyclic vomiting syndrome based on 2025 NASPGHAN guidelines
- English speaking
- No other explanation for vomiting
- External ear intact and free from infection or severe skin conditions
- Stable vital signs appropriate for age
- No implanted electrical devices
- Family able to report symptoms and vomiting episodes accurately
- At least 2 vomiting episodes in the past 6 months
You will not qualify if you...
- Medically complex children or those with other active diseases explaining symptoms
- Significant developmental delay in child or parents
- Diagnosis of alternate conditions explaining symptoms after medical evaluation
- Active diseases such as intestinal malrotation, peptic ulcer, gastritis, celiac disease, inflammatory bowel disease, allergies, hydronephrosis, metabolic disorders, or other chronic conditions causing vomiting
- Use of new central nervous system drugs within 4 weeks prior to enrollment
- Pregnancy
- Severe cardiopulmonary diseases like COPD or coronary artery disease
- Chronic marijuana use more than twice weekly over last 6 months
- Previous treatment with PENFS device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 5 consecutive weeks
Participants receive auricular neurostimulation using either an active or sham percutaneous electrical nerve field stimulation device worn for 5 days per week over 5 consecutive weeks.
Weekly visits for device placement and monitoring
Long-term Monitoring
Duration - 12 months
Participants are followed for 12 months after completion of therapy to assess treatment effects and quality of life.
Periodic follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Children's Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
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Research Team
R
Rachel Unteutsch, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition 2025 guidelines on the diagnosis of cyclic vomiting syndrome in children.
Katja Karrento, John M Rosen, Amy A Gelfand...
https://pubmed.ncbi.nlm.nih.gov/40836301Percutaneous Electrical Nerve Field Stimulation for Drug-Refractory Pediatric Cyclic Vomiting Syndrome.
Katja Karrento, Thangam Venkatesan, Liyun Zhang...
https://pubmed.ncbi.nlm.nih.gov/37364137Cardiac Vagal Regulation Is Impeded in Children With Cyclic Vomiting Syndrome.
Jacek Kolacz, Katja Kovacic, Linh Dang...
https://pubmed.ncbi.nlm.nih.gov/36716443