N/A
N=108
Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response
Functional Gastrointestinal Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03675321 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Nausea Severity Scale — 2.18; 2.45 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Auricular Neurostimulation (Device); Sham Auricular Neurostimulation (Device)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nausea Severity Scale |
2.18; 2.45 | — |
| SECONDARY Nausea Profile |
33.33; 28.43 | — |
| SECONDARY Baxter Retching Faces Scale |
2.29; 3.43 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03675321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.