Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

Not Applicable

Completed

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

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Percutaneous neurostimulation	Percutaneous neurostimulation	Subjects will have 4 weeks of active therapy.

Primary Outcome Measures

Name	Time	Method
To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity	Baseline, at follow-up visit 4 (Week 4) and at follow up visit 5 (Week 8 or 12)	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.

Secondary Outcome Measures

Name	Time	Method
To Measure Heart Rate Variability	At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and 5 (Week 8 or 12)	EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.
To Measure Functional Disability Inventory	At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and visit 5 (8 or 12)	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.