Auricular Neurostimulation for Cyclic Vomiting Syndrome

This trial tests a new treatment for cyclic vomiting syndrome (CVS), a condition characterized by intense bouts of vomiting interspersed with periods of normal health. The treatment involves a device for auricular neurostimulation, which sends gentle electrical signals to the ear to help regulate the vagus nerve, often linked to nausea and vomiting. Researchers aim to determine if this approach can reduce the frequency, duration, and severity of CVS episodes compared to a placebo device. Children who have experienced at least two vomiting episodes in the last six months and meet other criteria may qualify for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for CVS.

The trial does not specify if you need to stop taking your current medications. However, if you are taking a new drug affecting the central nervous system, you must not have started it within 4 weeks before joining the trial.

Research has shown that auricular neurostimulation, which stimulates a part of the ear to affect the vagus nerve, is generally safe for people with cyclic vomiting syndrome (CVS). In a small study, researchers found that this method was safe and improved symptoms in children with CVS. Another study with teenagers showed a significant reduction in pain without major side effects. These findings suggest that auricular neurostimulation is well-tolerated, making it a promising non-drug treatment option for managing CVS symptoms.¹²³⁴⁵

Auricular Neurostimulation is unique because it offers a non-drug approach to managing Cyclic Vomiting Syndrome (CVS), unlike traditional treatments like anti-nausea medications, antiepileptic drugs, or certain antidepressants. This innovative treatment uses Active Percutaneous Electrical Nerve Field Stimulation (PENFS), which involves mild electrical impulses targeting specific nerves in the ear to potentially reduce symptoms. Researchers are excited about this treatment because it provides a novel mechanism of action, focusing on nerve stimulation rather than chemical intervention, which may lead to fewer side effects and offer relief for patients who do not respond well to existing therapies.

Research has shown that stimulating the vagus nerve in the ear, known as auricular neurostimulation, may help treat cyclic vomiting syndrome (CVS). In this trial, participants will receive either Active Percutaneous Electrical Nerve Field Stimulation (PENFS) or a Sham PENFS device for 5 consecutive weeks. A small study demonstrated that auricular neurostimulation improved symptoms in children with CVS. Many studies suggest that stimulating the vagus nerve can help with pain and vomiting. One study found it significantly reduced pain in teenagers with similar digestive problems. Another study showed it was safe and improved the quality of life for children with pain-related issues. This treatment offers a non-drug option for CVS, potentially leading to fewer hospital visits and a better daily life.¹⁵⁶⁷⁸