Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

NCT03931330 | Completed Results FDA Device

• 1 other identifier: 1101710
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Gastrointestinal Disorders; Irritable Bowel Syndrome; Dyspepsia; Functional Abdominal Pain Syndrome

Keywords

FGID; Neural Stimulation; Functional Abdominal Pain; Dysautonomia

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• 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)

• 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)

Study Arms (1)

Percutaneous neurostimulation

EXPERIMENTAL

Subjects will have 4 weeks of active therapy.

Device: Percutaneous neurostimulation

Interventions

Percutaneous neurostimulation DEVICE

Percutaneous neurostimulation using NSS-2 Bridge device

Also known as: NSS-2 Bridge by Innovative Health Solutions

Percutaneous neurostimulation

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• 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.

  PMID: 25378088 BACKGROUND

• 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.

  PMID: 28826627 BACKGROUND

• 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.

  PMID: 23927739 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases; Irritable Bowel Syndrome; Dyspepsia; Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Results Point of Contact

• Title: Gisela Chelimsky, MD
• Organization: Medical College of Wisconsin

gchelimsky@mcw.edu

414-266-3690

Study Officials

• Gisela Chelimsky, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All subjects will receive the same electro auricular device

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 30, 2019
• Study Start: February 6, 2019
• Primary Completion: September 24, 2019
• Study Completion: September 24, 2019
• Last Updated: June 21, 2021
• Results First Posted: June 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)