NCT03675321

Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Functional Gastrointestinal Disorders

Interventions

Type	Name	Description
DEVICE	Active Auricular Neurostimulation	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.
DEVICE	Sham Auricular Neurostimulation	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.

Timeline

• Start date: 2018-04-23
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2018-09-18
• Last updated: 2025-11-20
• Results posted: 2023-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study