N/A
N=8
Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
Functional Gastrointestinal Disorders · Irritable Bowel Syndrome · Dyspepsia · Functional Abdominal Pain Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03931330 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity — 221.85; 151.14; 139.20 pmol/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Percutaneous neurostimulation (Device)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity |
221.85; 151.14; 139.20 | — |
| SECONDARY To Measure Heart Rate Variability |
100.31; 97.27; 93.86; 97.35 | — |
| SECONDARY To Measure Functional Disability Inventory |
26.53; 24.58; 22.70; 24.74 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03931330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.