Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-06

Study Completion Date

2019-09-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Functional Gastrointestinal Disorders Irritable Bowel Syndrome Dyspepsia Functional Abdominal Pain Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All subjects will receive the same electro auricular device

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Percutaneous neurostimulation

Subjects will have 4 weeks of active therapy.

Group Type EXPERIMENTAL

Percutaneous neurostimulation

Intervention Type DEVICE

Percutaneous neurostimulation using NSS-2 Bridge device

Interventions

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Percutaneous neurostimulation

Percutaneous neurostimulation using NSS-2 Bridge device

Intervention Type DEVICE

Other Intervention Names

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NSS-2 Bridge by Innovative Health Solutions

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No