Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

Medical College of Wisconsin

Status

Completed

Conditions

Irritable Bowel Syndrome

Functional Gastrointestinal Disorders

Dyspepsia

Functional Abdominal Pain Syndrome

Treatments

Device: Percutaneous neurostimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03931330

1101710

Details and patient eligibility

About

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.

Full description

In understanding the pathophysiology of pediatric functional gastrointestinal disorders (FGID), it has been documented that subjects have decreased vagal tone. Vagal tone in turn modulates mitochondrial bioenergetics and plays a role in anti inflammatory effects. Further defining these brain-body connections that underlie FGID's could help guide future treatment.

The investigators postulate that a 4 week neuro-stimulation with an Electro Auricular Device that has already shown to increase vagal tone will produce an increase in mitochondrial bioenergetics and decrease in inflammatory markers in this patient group.

Enrollment

8 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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