Clinical trial NCT03931330: Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
Official title: Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Irritable Bowel Syndrome
Dyspepsia
Functional Abdominal Pain Syndrome
Keywords: FGID
Neural Stimulation
Functional Abdominal Pain
Dysautonomia
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive the same electro auricular device
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity
timeFrame: Baseline, at follow-up visit 4 (Week 4) and at follow up visit 5 (Week 8 or 12)
Secondary outcomes:
measure: To Measure Heart Rate Variability
timeFrame: At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and 5 (Week 8 or 12)
measure: To Measure Functional Disability Inventory
timeFrame: At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and visit 5 (8 or 12)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Gisela Chelimsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: He X, Zhao M, Bi X, Sun L, Yu X, Zhao M, Zang W. Novel strategies and underlying protective mechanisms of modulation of vagal activity in cardiovascular diseases. Br J Pharmacol. 2015 Dec;172(23):5489-500. doi: 10.1111/bph.13010. Epub 2015 Jan 13.
citation: Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18.
citation: Liu Q, Wang EM, Yan XJ, Chen SL. Autonomic functioning in irritable bowel syndrome measured by heart rate variability: a meta-analysis. J Dig Dis. 2013 Dec;14(12):638-46. doi: 10.1111/1751-2980.12092.