Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

Medical College of Wisconsin

Status

Completed

Conditions

Functional Disorder of Intestine

Nausea Persistent

Treatments

Device: Sham

Device: Neurostimulator

Study type

Interventional

Funder types

Other

Identifiers

NCT02367729

KovacicK

Details and patient eligibility

About

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.

Full 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.

Enrollment

115 patients

Sex

All

Ages

11 to 18 years old

Volunteers

No Healthy Volunteers

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