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NCT07465614

A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome

Recruiting now NA Last updated 16 March 2026
What this trial tests

NA trial testing Active percutaneous electrical nerve field stimulation in Cyclic Vomiting Syndrome in 120 participants. Currently enrolling.

Timeline
11 February 2026
Primary endpoint
31 July 2028
31 December 2028

Quick facts

Lead sponsorMedical College of Wisconsin
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment120
Start date11 February 2026
Primary completion31 July 2028
Estimated completion31 December 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medical College of Wisconsin

Who can join

Adults 5 to 18, any sex, with Cyclic Vomiting Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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