Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

The vagus nerve innervates the gastrointestinal tract and influences the autonomic nervous
system. It is thought to carry signals of discomfort and nausea to the brain where it is
interpreted. The autonomic nervous system may be in imbalance in patients with functional
gastrointestinal disorders. By stimulating a branch of the vagus nerve in the outer ear, this
study aims to improve symptoms and quality of life in adolescents with functional abdominal
pain with or without nausea.

Subjects will be randomized into two groups: 1) neurostimulation versus 2) sham. They will
receive either an active or non-active (sham group) device for 5 days each week x 4 weeks
total. Pain, nausea, anxiety, quality of life, potential side effects and overall symptom
improvement will be monitored weekly for the entire study as well as after the study is
completed.

Inclusion Criteria:

- Adolescents with a major complaint of abdominal pain (minimum 3/10 in severity) with
or without nausea (minimum 3/10 in severity) of unclear etiology, who are
English-speaking and willing to participate and consent to the study and who have a
parent willing to participate.

- Patients with symptoms of minimum three times per week for a duration of two months or
greater

- Intact external ear that is free of infection or severe dermatological conditions.

- Stable vital signs for their respective age

Exclusion Criteria:

- Medically complex children or those who take a medication or suffer from an organic
disease that can explain symptoms will be excluded from participation.

- Children or parents, who have developmental delay, will be excluded due to
difficulties in accurately completing the questionnaires and assessing symptoms.

- History of seizures

- Currently implanted electrical device

- Orthostatic hypotension