Last updated on August 2019

Auricular Neurostimulation for Cyclic Vomiting Syndrome

Brief description of study

This study evaluates the efficacy of auricular neurostimulation via an non-invasive percutaneous electrical nerve field stimulator in children and adults with cyclic vomiting syndrome.

Detailed Study Description

Cyclic vomiting syndrome (CVS) is an difficult to treat and debilitating functional gastrointestinal disorder. Majority of children and adults with CVS have concurrent severe abdominal pain and migraine-features, rendering them incapacitated during the vomiting cycle.

The vagus nerve carries signals of nausea, vomiting and pain between the brain and the gastrointestinal tract and is part of the autonomic nervous system. The autonomic nervous system appears to be in imbalance in patients with CVS during a vomiting cycle. By stimulating a branch of the vagus nerve in the outer ear, this study aims to improve symptoms and quality of life in both children and adults with CVS.

Subjects will be randomized to receive active vs sham (non-active) neurostimulation therapy for 5 days at the onset of a CVS cycle. They will then cross over to the other group (active vs sham) at the onset of the next CVS cycle. Pain, nausea, vomiting, anxiety, quality of life, potential side effects and overall symptom improvement will be monitored after each therapy for the entire study as well as after the study is completed.

Clinical Study Identifier: NCT03434652

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