CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 109 enrolled
Drug / intervention
Active Auricular Neurostimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03675321
NCT03675321N/ACompleted
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Defining Adolescent Nausea Through Brain-Gut Physiology and Non-Invasive Neurostimulation Response

Medical College of Wisconsin·interventional·Posted Sep 18, 2018·Updated Nov 20, 2025

In Brief

A clinical study evaluating Active Auricular Neurostimulation and Sham Auricular Neurostimulation for Functional Gastrointestinal Disorders. Completed, enrolled 109 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFunctional Gastrointestinal Disorders
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 18, 2018
Enrollment StartApr 23, 2018
Primary CompletionFeb 28, 2022
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.8 years ago

Interventions

Active Auricular Neurostimulationdevice

Active auricular neurostimulation for 4 weeks. Subjects in Active group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy.

Sham Auricular Neurostimulationdevice

Sham auricular neurostimulation for 4 weeks with identical device as the active but lacking the electrical charge. Subjects in Sham group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy.