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NCT Number: NCT03675321

Defining Adolescent Nausea Through Brain Imaging and 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.

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Key information

Conditions

Functional Gastrointestinal Disorders Digestive System Diseases Gastrointestinal Diseases

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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:

  • To define adolescent functional nausea into subtypes based on clinical characterization and physiologic testing.
  • 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.
  • Investigate possible brain functional connectivity changes induced by auricular neurostimulation compared to patients with irritable bowel syndrome and healthy controls

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meeting pediatric Rome IV criteria for functional nausea
  • English-speaking and able to verbalize their condition and concerns about nausea, pain and other symptoms
  • Lack of other explanation for symptoms
  • Intact external ear that is free of infection or severe dermatological conditions, - - No currently implanted electrical device

Exclusion criteria

  • Medically complex and/or suffering from medical condition that may explain symptoms
  • Taking a medication that may explain symptoms
  • Significant developmental delays
  • Patients treated with a new drug affecting the central nervous system within 4 weeks of study start
  • Infection or severe dermatological condition of ear
  • Currently implanted electrical device
  • Patients with a history of severe allergy to adhesives

Treatment and study plan

Active Auricular Neurostimulation

Device

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.

Other names: Percutaneous Electrical Nerve Field Stimulation (PENFS), Neuro-Stim System-2

Sham Auricular Neurostimulation

Device

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.

Other names: Sham neurostimulation without electrical charge

Primary outcomes

  1. Nausea Severity Scale

    Time frame: After 4 weeks of therapy

    Measures 1) frequency of nausea on a scale 0-4 over past week (0=not at all; 4=every day), 2) average number of nausea episodes/day over past week on a scale 0-4 (0=none; 4=constant), 3) average duration of nausea episodes over past week on scale 0-4 (0=none; 4=most or all of day) and 4) severity of nausea on scale 0-10 (0=none;10=most nausea possible). The severity subscale is converted to a 5 point scale ranging from 0-4. The mean of all 4 subscales yields a total score ranging from 0 to 4, with a higher score indicating more severity.

Secondary outcomes

  1. Nausea Profile

    Time frame: After 4 weeks of therapy

    Measures 3 dimensions of nausea (Emotional, GI and Somatic distress) with 17 items. Each sub scale is measured on a 10-point scale from 0-9 (0=not at all; 9=severely). Total score is calculated as follows: actual score/153 * 100%. Subscales are similarly computed into a percentage score. Higher percentage indicates worse outcomes.

  2. Baxter Retching Faces Scale

    Time frame: Average score during week 4 of therapy

    Measures daily nausea severity on a pictorial faces scale from 0-10 (0=no nausea; 10=most nausea possible). Weekly averages will be computed and change from baseline to average severity during last week of therapy will be assessed. Higher values indicate worse outcome.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 18, 2018
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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