Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

Completed · Not applicable

Conditions studied: Functional Gastrointestinal Disorders, Irritable Bowel Syndrome, Dyspepsia, Functional Abdominal Pain Syndrome

In brief

This study evaluates the effect of auricular neurostimulation on mitochondrial bioenergetics and inflammation through vagal nerve modulation via non-invasive percutaneous electrical nerve field stimulator in children with functional gastrointestinal disorders.

Key facts

Study ID

NCT03931330

Run by

Medical College of Wisconsin

People needed

8

Starts

2019-02-06

Expected to finish

2019-09-24

Last updated by the study team

2021-06-21

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• English-speaking and able to verbalize their condition and concerns about nausea, pain and other symptoms
• Subjects will meet Rome IV criteria for functional nausea, irritable bowel syndrome, dyspepsia or functional abdominal pain as determined by a pediatric gastroenterologist
• Patients must have an intact external ear that is free of infection or severe dermatological conditions, have stable vital signs for their respective age, no history of seizures and no currently implanted electrical device

You may not qualify if…

• Mental retardation or pervasive developmental disorder or epilepsy
• Psychosis
• Genetic or chromosomal disorders
• Pregnancy
• Subjects who admit to substance abuse during screening
• Patients with findings of peptic ulcer disease, H.pylori gastritis, celiac disease, inflammatory bowel disease, allergic disorders, or any chronic condition or medication that may cause nausea or pain
• Patients who are treated with opioids or who had any changes in their medical regimen in the past four weeks prior to study
• Patients with a history of allergy to adhesives

Where it is running

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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