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Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

Primary Purpose

Functional Gastrointestinal Disorders, Irritable Bowel Syndrome, Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous neurostimulation
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Gastrointestinal Disorders focused on measuring FGID, Neural Stimulation, Functional Abdominal Pain, Dysautonomia

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Percutaneous neurostimulation

Arm Description

Subjects will have 4 weeks of active therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 22, 2019
Last Updated
May 27, 2021
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT03931330
Brief Title
Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
Official Title
Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
September 24, 2019 (Actual)
Study Completion Date
September 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders, Irritable Bowel Syndrome, Dyspepsia, Functional Abdominal Pain Syndrome
Keywords
FGID, Neural Stimulation, Functional Abdominal Pain, Dysautonomia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will receive the same electro auricular device
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous neurostimulation
Arm Type
Experimental
Arm Description
Subjects will have 4 weeks of active therapy.
Intervention Type
Device
Intervention Name(s)
Percutaneous neurostimulation
Other Intervention Name(s)
NSS-2 Bridge by Innovative Health Solutions
Intervention Description
Percutaneous neurostimulation using NSS-2 Bridge device
Primary Outcome Measure Information:
Title
To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity
Description
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 Outcome Measure Information:
Title
To Measure Heart Rate Variability
Description
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)
Title
To Measure Functional Disability Inventory
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisela Chelimsky, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25378088
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.
Results Reference
background
PubMed Identifier
28826627
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.
Results Reference
background
PubMed Identifier
23927739
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.
Results Reference
background

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Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

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