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Trial record 8 of 20 for:    Recruiting, Not yet recruiting, Available Studies | Pain | Neurostimulation

Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

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

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.

Condition or disease Intervention/treatment Phase
Functional Gastrointestinal Disorders Irritable Bowel Syndrome Dyspepsia Functional Abdominal Pain Syndrome Device: Percutaneous neurostimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects will receive the same electro auricular device
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: Percutaneous neurostimulation
Subjects will have 4 weeks of active therapy.
Device: Percutaneous neurostimulation
Percutaneous neurostimulation using NSS-2 Bridge device
Other Name: NSS-2 Bridge by Innovative Health Solutions




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931330


Contacts
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Contact: Douglas Bierer, MS 414-955-0688 dwbierer@mcw.edu
Contact: Ian Worcester, BS 414-955-0604 iworcester@mcw.edu

Locations
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United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Gisela Chelimsky    414-266-3690    gchelimsky@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Gisela Chelimsky, MD Medical College of Wisconsin

Publications:
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Responsible Party: Chelimsky, Gisela Grotewold, Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03931330     History of Changes
Other Study ID Numbers: 1101710
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Chelimsky, Gisela Grotewold, Medical College of Wisconsin:
FGID
Neural Stimulation
Functional Abdominal Pain
Dysautonomia
Additional relevant MeSH terms:
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Abdominal Pain
Pain
Irritable Bowel Syndrome
Gastrointestinal Diseases
Syndrome
Dyspepsia
Digestive System Diseases
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Neurologic Manifestations