A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome

Conditions

• Cyclic Vomiting Syndrome

Eligibility Criteria

Sex

ALL

Age

5 Years - 18 Years

Healthy Volunteers

Not accepted

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
• 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

Study Details

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.

Key Dates

Start date

Feb 11, 2026

Status verified

Mar 2026

Primary completion

Jul 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

Primary Outcome Measure

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

Central Contacts

• Rachel Unteutsch, BS
  4142664844
  [email protected]

Locations (1)

Find similar trials in Milwaukee, WI

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