Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

Medical College of Wisconsin8 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Functional Gastrointestinal Disorders Irritable Bowel Syndrome Dyspepsia Functional Abdominal Pain Syndrome

Interventions

Percutaneous neurostimulationDEVICE

Percutaneous neurostimulation using NSS-2 Bridge device

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity

Blood draw will be tested for mitochondrial function, including basal respiratory capacity, ATP production and spare respiration and to detect changes in protein which can be an indicator for inflammation. Basal Respiratory Capacity (pmol/min) is better when value is higher.

Time frame: Baseline, at follow-up visit 4 (Week 4) and at follow up visit 5 (Week 8 or 12)

Secondary Outcomes

To Measure Heart Rate Variability

EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.

Time frame: At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and 5 (Week 8 or 12)

To Measure Functional Disability Inventory

The Functional Disability Inventory (FDI) questionnaire will be used to assess change in symptoms. Participants will rank physical trouble or difficulty completing 15 different daily activities (Eating regular meals, Being at school all day, Walking up stairs, etc.) on a scale of 0-4. Scale:0-No trouble 1. A little trouble 2. Some Trouble 3. A lot of Trouble 4. Impossible Higher scores (4) indicate more difficulty functioning due to physical health. The total score ranges from 0 to 60 among 15 questions. The individual score for all 15 questions are added together for the total score. If all 15 questions are answered as 0- no trouble then the total score would be 0 (lowest difficulty). If all 15 questions are answered as 4-Impossible, then the total score would be 60 (highest difficulty). An assortment of answers will fall within this 0-60 range depending on the difficulty level answer for each question.

Time frame: At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and visit 5 (8 or 12)

Data from ClinicalTrials.gov

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