Healthy Clinical Trial
— AVNSOfficial title:
Effects of Transauricular Vagal Nerve Stimulation on Electrogastrography (EGG) and Heart Rate Variability (HRV) in Healthy Subjects, Functional Dyspepsia, and Gastroparesis
NCT number | NCT05405842 |
Other study ID # | 63421 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2023 |
Est. completion date | May 2025 |
The goal of this study is to establish parameters of gastric myoelectrical activity and heart rate variability in healthy human subjects and compare and contrast them to those with gastroparesis and functional dyspepsia, at baseline and following taVNS.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Male or female. 2. Age 18-85 years. 3. Healthy volunteer or established diagnosis of idiopathic, diabetic, or postsurgical gastroparesis and functional dyspepsia. 4. Patient is capable of giving informed consent. 5. Patient is on stable doses of other medications for gastroparesis or functional dyspepsia for preceding 4 weeks prior to enrollment (including cholinergics, anti-cholinergics, dopamine and serotonin receptor agonists/antagonists, motility agents, neuromodulators, herbals). Exclusion Criteria: 1. Any diagnosis of systemic autonomic dysfunction. 2. Use of narcotic, anticholinergic, cholinergic, or promotility medications in preceding 2 weeks of study. 3. Enteric feeding tubes. 4. Parenteral nutrition. 5. Severe disease flare requiring hospitalization or ER visits within 3 months of study. 6. Untreated depression or suicidal thoughts. 7. Pregnant/breastfeeding women. 8. History of gastric pacemaker implantation. 9. Implantable electronic devices (i.e. cardiac pacemakers) 10. Extrinsic myopathy/neuropathy 11. Vagal nerve injury. 12. High risk cardiac arrhythmias (high grade AV block, atrial fibrillation, atrial flutter). 13. GERD. 14. History of dumping syndrome. 15. History of rapid gastric emptying. 16. Severe allergy to skin adhesives. 17. Concurrent enrollment in other clinical trials. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Determine Stimulation Parameters of tAVNS with Greater Effect on Gastroparesis and Functional Dyspepsia | To determine what stimulation parameters have a greater effect on EGG variables (gastric slow wave power, propagation, and phase gradient directionality,) and HRV variables (mean HR, mean RR, LF, HF) in gastroparesis and functional dyspepsia patients. | 3-5 years | |
Primary | Establish EGG/HRV parameters and effects following taVNS | The first primary outcome measure will be to establish measures of EGG and HRV parameters in healthy volunteers and determine effects of tAVNS on EGG and HRV. The HRV parameters to be measured will include mean heart rate (HR), standard deviation of HR, mean respiratory rate (RR) interval, standard deviation of RR interval, low/high frequency (LF, HF, LF/HF), normalized LF, and normalized HF. The EGG parameters to be measured will be of gastric slow wave power, gastric slow wave propagation, and phase gradient directionality. | 3-5 years | |
Secondary | Determine deviations in EGG/HRV parameters and effects following taVNS | To determine if gastroparesis or functional dyspepsia patients have significant deviations in EGG (slow wave power, propagation, and phase gradient directionality) and HRV (mean HR, LF, HF, mean RR) parameters at baseline and following tAVNS compared to healthy volunteers. | 3-5 years |
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