Recruiting

PENFS

Sponsor:

Medical College of Wisconsin

Code:

NCT07465614

Conditions

Cyclic Vomiting Syndrome

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Interventions

Active percutaneous electrical nerve field stimulation

Sham percutaneous electrical nerve field stimulation

Study Details

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

Study ID

NCT07465614

Start date

Feb 11, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Percutaneous Electrical Nerve Field Stimulation (PENFS)

Active PENFS device x 5 consecutive weeks

sham comparator: Sham Percutaneous Electrical Nerve Field Stimulation (PENFS)

Sham PENFS device x 5 consecutive weeks

Interventions

Active percutaneous electrical nerve field stimulation

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

Sham percutaneous electrical nerve field stimulation

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

Primary outcome measure

  • Cyclic Vomiting Syndrome Burden Index [ Time Frame: From enrollment (baseline) to 6 months after end of treatment ]

Central Contacts and Locations

Central contacts

Rachel Unteutsch, BS

4142664844runteutsch@mcw.edu

Locations

Children's Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Lisa Nielson, BS

4142663695lnielson@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-03-16.