NCT02367729

Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

Efficacy of Auricular Neurostimulation for Adolescents With Pain-Associated Functional Gastrointestinal Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Functional Disorder of Intestine
• Nausea Persistent

Interventions

Type	Name	Description
DEVICE	Neurostimulator	Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks.
DEVICE	Sham	Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2015-02-20
• Last updated: 2018-11-08
• Results posted: 2018-10-12

Locations

1 site across 1 country: United States