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Defining Adolescent Nausea Through Brain-Gut Physiology and Non-Invasive Neurostimulation Response
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.
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
Age
11 - 18 years
Sex
ALL
Healthy Volunteers
Yes
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Start Date
April 23, 2018
Primary Completion Date
February 28, 2022
Completion Date
February 28, 2022
Last Updated
November 20, 2025
109
ACTUAL participants
Active Auricular Neurostimulation
DEVICE
Sham Auricular Neurostimulation
DEVICE
Lead Sponsor
Medical College of Wisconsin
Collaborators
NCT03823742
NCT06309199
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06268964