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NCT07465614 · ClinicalTrials.gov registry record · NA
A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
A NA study of Cyclic Vomiting Syndrome, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT07465614: Recruiting NA study of Cyclic Vomiting Syndrome, sponsored by Medical College of Wisconsin.
NCT07465614 is a NA study of Cyclic Vomiting Syndrome that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 120 participants, above the 92-participant average among 3 other Cyclic Vomiting Syndrome trials with a reported enrollment target (30% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07465614, a NA study of Cyclic Vomiting Syndrome, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Active percutaneous electrical nerve field stimulation
- DEVICE Sham percutaneous electrical nerve field stimulation
Study Locations (1)
Wisconsin
- Children's Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-02-11 |
| Est. Completion | 2028-12-31 |
| Phase | NA |
What NCT07465614 shows while recruiting
NCT07465614 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 92-participant average among 3 other Cyclic Vomiting Syndrome trials with a reported enrollment target (30% higher).
The record links to 1 condition, with Cyclic Vomiting Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Active percutaneous electrical nerve field stimulation is the first listed.
NCT07465614 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT07465614 about?
NCT07465614 is a clinical study titled "A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome". 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 ar...
What is the current status of trial NCT07465614?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2026-02-11. Estimated completion is 2028-12-31.
What conditions does trial NCT07465614 study?
This clinical trial studies the following conditions: Cyclic Vomiting Syndrome.
What interventions are being tested in trial NCT07465614?
The interventions under investigation include: Active percutaneous electrical nerve field stimulation (DEVICE), Sham percutaneous electrical nerve field stimulation (DEVICE).
Who is sponsoring clinical trial NCT07465614?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07465614 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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