Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response

Functional Gastrointestinal Disorders Clinical Trial

Official title: Defining Adolescent Nausea Through Brain-Gut Physiology and Non-Invasive Neurostimulation Response

Status Completed

Clinical Trial Summary

This study evaluates the efficacy of auricular neurostimulation via an non-invasive percutaneous electrical nerve field stimulator (PENFS) in adolescents with functional nausea. A neurostimulator is applied to the outer ear and stimulates several nerves that are thought to be involved in transmission of nausea and vomiting signals. Half of the study subjects will receive an active nerve stimulator while the other half will receive an inactive one.

Clinical Trial Description

By stimulating branches of several cranial nerves in the outer ear, this study aims to improve symptoms and quality of life in adolescents with functional nausea.

The study has the following specific aims:

1. To define adolescent functional nausea into subtypes based on clinical characterization and physiologic testing.

2. Evaluating the efficacy of auricular neurostimulation via PENFS for functional nausea. Subjects will be randomized into two groups: 1) neurostimulation versus 2) sham. They will receive either an active or non-active (sham group) device for 5 days each week x 4 weeks total. Those who do not improve will receive an additional 4 weeks of therapy with active stimulation.

3. Investigate possible brain functional connectivity changes induced by auricular neurostimulation compared to patients with irritable bowel syndrome and healthy controls ;

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

• NCT number: NCT03675321
• Study type: Interventional
• Source: Medical College of Wisconsin
• Status: Completed
• Phase: N/A
• Start date: April 23, 2018
• Completion date: February 28, 2022