Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain
Completed · Not applicable · Has a placebo group
Conditions studied: Functional Disorder of Intestine, Nausea Persistent
In brief
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.
Key facts
- Study ID
- NCT02367729
- Run by
- Medical College of Wisconsin
- People needed
- 115
- Starts
- 2015-09-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2018-11-08
Who can join
Age: 11 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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