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
|Condition or disease||Intervention/treatment||Phase|
|Functional Gastrointestinal Disorders Irritable Bowel Syndrome Dyspepsia Functional Abdominal Pain Syndrome||Device: Percutaneous neurostimulation||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All subjects will receive the same electro auricular device|
|Masking:||None (Open Label)|
|Official Title:||Does Improving Vagal Tone Increase Mitochondrial Bioenergetics|
|Actual Study Start Date :||October 10, 2017|
|Actual Primary Completion Date :||September 24, 2019|
|Actual Study Completion Date :||September 24, 2019|
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
- 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
- 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.
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
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Gisela Chelimsky, MD||Medical College of Wisconsin|