N/A
N=47
Auricular Neurostimulation for Cyclic Vomiting Syndrome
Cyclic Vomiting Syndrome · Abdominal Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03434652 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Rhodes Index of Nausea, Vomiting & Retching (INVR) — 3.25; 5.80; 10.43; 0.75 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Percutaneous neurostimulation (Device)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rhodes Index of Nausea, Vomiting & Retching (INVR) |
3.25; 5.80; 10.43; 0.75; 1.50; 2.31 | — |
| SECONDARY Numeric Pain Scale |
4; 4.7; 1; 1.3 | — |
| SECONDARY Anxiety |
63.5; 28; 29; 51; 49; 23.5 | — |
| SECONDARY Patient Reported Outcomes Measurement Information Systems- Health-Related Quality of Life |
25.4; 13.0; 10.0; 27.8; 27.8; 16.0 | — |
| SECONDARY Functional Disability Inventory- Disability in Children |
47.5; 45.5; 44; 38; 45.5; 34 | — |
| SECONDARY Disability in Adults |
— | — |
| SECONDARY Symptom Response Scale |
5; 5; 0 | — |
Summary
This study evaluates the efficacy of auricular neurostimulation via an non-invasive percutaneous electrical nerve field stimulator in children and adults with cyclic vomiting syndrome.
Eligibility Criteria
Inclusion Criteria
- Meeting Rome IV Pediatric or Adult criteria for Cyclic Vomiting Syndrome (CVS)
- Concurrent abdominal pain with CVS cycle
- English-speaking
- Lack of other explanation for symptoms
- Either predictable, 'calendar-timed' episodes or prodromal symptoms for 12-24 hours that are predictive of episodes onset
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 one week of enrollment
- Infection or severe dermatological condition of ear
- Stable vital signs
- No currently implanted electrical device
- For adults (and adolescents as applicable): pregnancy, severe cardiopulmonary disease, concurrent chronic marijuana use (>2 times/month over past 6 months prior to enrollment)
Data sourced from ClinicalTrials.gov (NCT03434652). 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.