Does Improving Vagal Tone Increase Mitochondrial Bioenergetics (NCT03931330) | Clinical Trial Compass
CompletedNot Applicable
Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
United States8 participantsStarted 2019-02-06
Plain-language 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.
Who can participate
Age range12 Years ā 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity
Timeframe: Baseline, at follow-up visit 4 (Week 4) and at follow up visit 5 (Week 8 or 12)