Nausea Persistent Clinical Trial
Official title:
Efficacy of Auricular Neurostimulation for Adolescents With Pain-Associated Functional Gastrointestinal Disorders
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.
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Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Terminated |
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N/A |