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Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

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ClinicalTrials.gov Identifier: NCT03931330
Recruitment Status : Completed
First Posted : April 30, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Chelimsky, Gisela Grotewold, Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE October 10, 2017
Actual Primary Completion Date September 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
Mitochondrial Bioenergetics [ Time Frame: At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit after receiving 3 cycles of therapy (each cycle is 5 days of device use followed by 2 days without device), and at follow up visit 1-2 months after end of therapy. ]
Blood draw will be tested for mitochondrial function and to detect changes in protein which can be an indicator for inflammation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03931330 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Heart Rate Variability [ Time Frame: At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit after receiving 3 cycles of therapy (each cycle is 5 days of device use followed by 2 days without device), and at follow up visit 1-2 months after end of therapy. ]
    EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.
  • Functional Disability Inventory [ Time Frame: At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit after receiving 3 cycles of therapy (each cycle is 5 days of device use followed by 2 days without device), and at follow up visit 1-2 months after end of therapy. ]
    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 (No trouble - Impossible). Higher scores indicate more difficulty functioning due to physical health.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
Official Title  ICMJE Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
All subjects will receive the same electro auricular device
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Functional Gastrointestinal Disorders
  • Irritable Bowel Syndrome
  • Dyspepsia
  • Functional Abdominal Pain Syndrome
Intervention  ICMJE Device: Percutaneous neurostimulation
Percutaneous neurostimulation using NSS-2 Bridge device
Other Name: NSS-2 Bridge by Innovative Health Solutions
Study Arms  ICMJE Experimental: Percutaneous neurostimulation
Subjects will have 4 weeks of active therapy.
Intervention: Device: Percutaneous neurostimulation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2019)
7
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 24, 2019
Actual Primary Completion Date September 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03931330
Other Study ID Numbers  ICMJE 1101710
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chelimsky, Gisela Grotewold, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gisela Chelimsky, MD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP