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NCT07465614
A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
NA trial testing Active percutaneous electrical nerve field stimulation in Cyclic Vomiting Syndrome in 120 participants. Currently enrolling.
31 July 2028
Quick facts
| Lead sponsor | Medical College of Wisconsin |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 11 February 2026 |
| Primary completion | 31 July 2028 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Active percutaneous electrical nerve field stimulation
- Sham percutaneous electrical nerve field stimulation
Conditions studied
- Cyclic Vomiting Syndrome — all drugs for Cyclic Vomiting Syndrome →
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.
Verify or expand the search:
- PubMed search for NCT07465614
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07465614 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical College of Wisconsin
- Last refreshed: 16 March 2026
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