A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome

NCT07465614 | Recruiting FDA Device

• 1 other identifier: PRO00055846
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 severe abdominal pain and migraine-features, causing significant disability during the attacks. There are very few non-drug treatment options for CVS. Many patients are treated with antidepressants that are often ineffective and may cause serious side effects. Emergency room visits and hospitalizations for patients with CVS is extremely high and the syndrome has an immense impact on quality of life. Safe and effective, non-pharmacological therapies for children with CVS are greatly needed. Nausea, vomiting and gastrointestinal pain is modulated by the vagus nerve, an important regulator of the autonomic nervous system. The vagus communicates signals between the gastrointestinal tract and the central nervous system. Many studies indicate that vagal nerve stimulation is effective for various pain and vomiting conditions. Recent studies show that vagus nerve signaling is impaired in children with CVS. Researchers have demonstrated safety and efficacy of auricular percutaneous electrical nerve field stimulation (PENFS) targeting the vagus nerve in a small study of children with CVS. The aim of the current study is to investigate the effects of non-invasive PENFS on CVS episode frequency, duration and severity compared to a sham device in a randomized clinical trial.

Conditions

Cyclic Vomiting Syndrome

Keywords

auricular neurostimulation; vagus nerve stimulation; cyclic vomiting syndrome in children

Outcome Measures

Primary Outcomes (1)

• Cyclic Vomiting Syndrome Burden Index

  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.

  From enrollment (baseline) to 6 months after end of treatment

Secondary Outcomes (2)

• Pediatric Migraine Disability Assessment (PedMIDAS)

  From enrollment (baseline) to 6 months after end of therapy

• Symptom Response Scale

  From enrollment (baseline) to 6 months after end of treatment

Study Arms (2)

Active Percutaneous Electrical Nerve Field Stimulation (PENFS)

EXPERIMENTAL

Active PENFS device x 5 consecutive weeks

Device: Active percutaneous electrical nerve field stimulation

Sham Percutaneous Electrical Nerve Field Stimulation (PENFS)

SHAM COMPARATOR

Sham PENFS device x 5 consecutive weeks

Device: Sham percutaneous electrical nerve field stimulation

Interventions

Active percutaneous electrical nerve field stimulation DEVICE

Auricular vagus nerve stimulation using an percutaneously placed, active device that is worn for 5 days/week for several consecutive weeks

Also known as: IB-stim

Active Percutaneous Electrical Nerve Field Stimulation (PENFS)

Sham percutaneous electrical nerve field stimulation DEVICE

Auricular vagus nerve stimulation using a sham device that is percutaneously placed on the wear and worn for 5 days/week for several consecutive weeks

Also known as: IB-stim

Sham Percutaneous Electrical Nerve Field Stimulation (PENFS)

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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
• 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

You may not qualify 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 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (4)

• Karrento K, Rosen JM, Tarbell SE, Issenman RM, Gelfand AA, Gamboa H, Parikh S, Adams K, Wiercioch W, Li BUK. North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition 2025 guidelines for management of cyclic vomiting syndrome in children. J Pediatr Gastroenterol Nutr. 2025 Jun;80(6):1028-1061. doi: 10.1002/jpn3.70020. Epub 2025 Apr 14.

  PMID: 40223700 BACKGROUND

• Karrento K, Rosen JM, Gelfand AA, Parikh S, Tarbell SE, Issenman RM, Gamboa H, Adams K, Wiercioch W, Li BUK. North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition 2025 guidelines on the diagnosis of cyclic vomiting syndrome in children. J Pediatr Gastroenterol Nutr. 2025 Nov;81(5):1346-1359. doi: 10.1002/jpn3.70193. Epub 2025 Aug 20.

  PMID: 40836301 BACKGROUND

• Karrento K, Venkatesan T, Zhang L, Pawela L, Simpson P, Li BUK. Percutaneous Electrical Nerve Field Stimulation for Drug-Refractory Pediatric Cyclic Vomiting Syndrome. J Pediatr Gastroenterol Nutr. 2023 Sep 1;77(3):347-353. doi: 10.1097/MPG.0000000000003876. Epub 2023 Jun 26.

  PMID: 37364137 BACKGROUND

• Kolacz J, Kovacic K, Dang L, Li BUK, Lewis GF, Porges SW. Cardiac Vagal Regulation Is Impeded in Children With Cyclic Vomiting Syndrome. Am J Gastroenterol. 2023 Jul 1;118(7):1268-1275. doi: 10.14309/ajg.0000000000002207. Epub 2023 Jan 30.

  PMID: 36716443 BACKGROUND

MeSH Terms

Conditions

Familial cyclic vomiting syndrome

Study Officials

• Gila Ginzburg, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Unteutsch, BS

CONTACT

4142664844; runteutsch@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research coordinator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: Subjects randomized 2:1 to active vs sham therapy arms

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: End of data collection (12/2028) through following year (12/2029)
• Access Criteria: Other investigators may access de-identified patient reported outcome survey data upon request. Data would be shared if permitted by IRB by exporting de-identfied data from Redcap database.

Locations

US (1)