Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response

Medical College of Wisconsin

Status: Completed

Conditions: Functional Gastrointestinal Disorders

Treatments: Device: Sham Auricular Neurostimulation; Device: Active Auricular Neurostimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03675321

1064187-2

1K23DK116969-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 109 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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109 participants in 2 patient groups

Auricular Neurostimulation

Experimental group

Description:

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

Treatment:

Device: Active Auricular Neurostimulation

Sham Auricular Neurostimulation

Sham Comparator group

Description:

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

Treatment:

Device: Sham Auricular Neurostimulation