Defining Adolescent Nausea Through Brain-Gut Physiology and Non-Invasive Neurostimulation Response
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Gastrointestinal Disorders
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Nausea Severity Scale
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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
Investigators
Katja Karrento
Associate Professor
Medical College of Wisconsin
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Nausea Profile(After 4 weeks of therapy)
- Baxter Retching Faces Scale(Average score during week 4 of therapy)