Trials / Completed
CompletedNCT03931330
Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Medical College of Wisconsin · Academic / Other
- Sex
- All
- Age
- 12 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Functional Gastrointestinal Disorders
- Irritable Bowel Syndrome
- Dyspepsia
- Functional Abdominal Pain Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Percutaneous neurostimulation | Percutaneous neurostimulation using NSS-2 Bridge device |
Timeline
- Start date
- 2019-02-06
- Primary completion
- 2019-09-24
- Completion
- 2019-09-24
- First posted
- 2019-04-30
- Last updated
- 2021-06-21
- Results posted
- 2021-06-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03931330. Inclusion in this directory is not an endorsement.