Auricular Neurostimulation for Cyclic Vomiting Syndrome

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. Pain, nausea, vomiting, anxiety, quality of
life, potential side effects and overall symptom improvement will be monitored after each
therapy for the entire study as well as after the study is completed.

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)