Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

Irritable Bowel Syndrome Clinical Trial

Official title:

Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931330
• Other study ID #: 1101710
• Status: Completed
• Phase: N/A
• Start date: February 6, 2019
• Est. completion date: September 24, 2019

Study information

• Verified date: May 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 24, 2019
• Est. primary completion date: September 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

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

Related Conditions & MeSH terms

• Abdominal Pain
• Digestive System Diseases
• Dyspepsia
• Functional Abdominal Pain Syndrome
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Irritable Bowel Syndrome
• Syndrome

Intervention

Device:
• Percutaneous neurostimulation
Percutaneous neurostimulation using NSS-2 Bridge device

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and 5 (Week 8 or 12)
Secondary	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; A little trouble; Some Trouble; A lot of Trouble; 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.	At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and visit 5 (8 or 12)