Status:
COMPLETED
Auricular Neurostimulation for Cyclic Vomiting Syndrome
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Cyclic Vomiting Syndrome
Abdominal Migraine
Eligibility:
All Genders
8-65 years
Phase:
NA
Brief 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.
Detailed Description
Cyclic vomiting syndrome (CVS) is an difficult to treat and debilitating functional gastrointestinal disorder. Majority of children and adults with CVS have concurrent severe abdominal pain and migrai...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2021
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03434652
Start Date
January 31 2018
End Date
March 3 2021
Last Update
April 12 2022
Active Locations (1)
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1
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226