Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain
Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain
This study evaluates the effectiveness of a neurostimulator applied to the outer ear for
 adolescents with functional gastrointestinal disorders. The neurostimulator provides nerve
 stimulation to a branch of the vagus nerve which is thought to be involved in transmission of
 pain signals. Half of the study subjects will receive an active nerve stimulator while the
 other half will receive an inactive one.
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