Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response

Not Applicable

Completed

Interventions: Device: Active Auricular Neurostimulation
Device: Sham Auricular Neurostimulation

Brief 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

Recruitment & Eligibility

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Nausea Severity Scale	Change from baseline Nausea Severity Scale score at 4 weeks.	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 Outcome Measures

Name	Time	Method
Nausea Profile	Change from baseline total Nausea Profile score at 4 weeks.	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.
Baxter Retching Faces Scale	Change from baseline Baxter Retching Faces scale score at 4 weeks.	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.