Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-23

Study Completion Date

2022-02-28

Brief Summary

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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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Detailed Description

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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

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Functional Gastrointestinal Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double blind placebo-controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

All participants, investigators and study team members blinded

Study Groups

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Auricular Neurostimulation

Intervention: Active Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks

Group Type EXPERIMENTAL

Active Auricular Neurostimulation

Intervention Type 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.

Sham Auricular Neurostimulation

Intervention: Sham (Inactive) Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks.

Group Type SHAM_COMPARATOR

Sham Auricular Neurostimulation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Percutaneous Electrical Nerve Field Stimulation (PENFS) Neuro-Stim System-2 Sham neurostimulation without electrical charge

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes