Auricular Neurostimulation for Cyclic Vomiting Syndrome

Study Overview
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Brief Summary
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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
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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 migraine-features, rendering them incapacitated during the vomiting cycle. The vagus nerve carries signals of nausea, vomiting and pain between the brain and the gastrointestinal tract and is part of the autonomic nervous system. The autonomic nervous system appears to be in imbalance in patients with CVS during a vomiting cycle. By stimulating a branch of the vagus nerve in the outer ear, this study aims to improve symptoms and quality of life in both children and adults with CVS. Subjects will be randomized to receive active vs sham (non-active) neurostimulation therapy for 5 days at the onset of a CVS cycle. They will then cross over to the other group (active vs sham) at the onset of the next CVS cycle. Subjects in a separate sub-study receive 6 weeks of active neurostimulation therapy (5 days/week). Pain, nausea, vomiting, anxiety, quality of life, potential side effects and overall symptom improvement will be monitored before and after therapy for the entire study.

Official Title
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Efficacy of Auricular Neurostimulation for Children and Adults With Cyclic Vomiting Syndrome: a Pilot Study

Conditions
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Cyclic Vomiting Syndrome, Abdominal Migraine

Intervention / Treatment
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* Device: Percutaneous neurostimulation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each subject randomized to active vs sham therapy, then cross over to the other during next illness cycle
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active percutaneous neurostimulation<br>Subject randomized to 5 days of active vs sham neurostimulation therapy during an illness cycle. With next illness cycle, each subject will cross over to the other one (active vs sham). | Device: Percutaneous neurostimulation<br>* Auricular percutaneous neurostimulation<br>* Other names: Neuro-Stim System (NSS)-2 BRIDGE;|
| Sham Comparator: Sham percutaneous neurostimulation<br>Each subject randomized to 5 days of active vs sham neurostimulation therapy during an illness cycle. With next illness cycle, each subject will cross over to the other one (active vs sham). | Device: Percutaneous neurostimulation<br>* Auricular percutaneous neurostimulation<br>* Other names: Neuro-Stim System (NSS)-2 BRIDGE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baxter Retching Faces Scale | Daily nausea severity assessed by pictorial nausea faces scale 0-10 (0=no nausea; 10=worse possible nausea) with higher scores indicating worse outcomes (greater nausea). | From date of baseline assessment (therapy start date) through next 7 days for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric pain scale | Daily pain severity assessed by numeric pain scale 0-10 (0=no pain; 10=worst possible pain) with higher scores indicating worse outcome (greater pain). | From date of baseline assessment (therapy start date) through next 7 days for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. | 
| Anxiety | State-Trait Anxiety Inventory for Children and Adults | From date of baseline assessment (therapy start date) and day 5 of therapy for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. | 
| Health-Related Quality of Life | Patient Reported Outcomes Measurement Information Systems | From date of baseline assessment (therapy start date) and day 5 of therapy for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. | 
| Disability in Children | Functional Disability Inventory | From date of baseline assessment (therapy start date) and day 5 of therapy for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. | 
| Disability in Adults | Sheehan Disability Scale assessing disability and impairment on a scale 0-10 with higher scores indicating more disability. Three sub scales: 1) school/work, 2) social life and 3) family life are assessed (scale 0-10) with a total score reflecting the sum of the 3 subscales (total score range 0-30 with higher score indicating more disability). | From date of baseline assessment (therapy start date) and day 5 of therapy for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. | 
| Global symptoms | Global symptom improvement scale | From date of baseline assessment (therapy start date) and day 5 of therapy for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. |