Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis
Megadott ok: There were equipment issues with the vendor that could not be resolved; therefore, enrollment was never opened.
A vizsgálat adatai
- Ki végzi
- Stanford University
- Azonosító
- NCT05405842
- A regiszteradat frissítve
- 2025. augusztus 3.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Effects of Transauricular Vagal Nerve Stimulation on Electrogastrography (EGG) and Heart Rate Variability (HRV) in Healthy Subjects, Functional Dyspepsia, and Gastroparesis
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.
Bevonási feltételek: Male or female; Age 18-85 years; Healthy volunteer or established diagnosis of idiopathic, diabetic, or postsurgical gastroparesis and functional dyspepsia; Patient is capable of giving informed consent; 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).
Kizáró feltételek: Use of narcotic, anticholinergic, cholinergic, or promotility medications in preceding 2 weeks of study; Concurrent enrollment in other clinical trials; Severe disease flare requiring hospitalization or ER visits within 3 months of study; History of gastric pacemaker implantation; Implantable electronic devices (i.e. cardiac pacemakers); High risk cardiac arrhythmias (high grade AV block, atrial fibrillation, atrial flutter); History of dumping syndrome; History of rapid gastric emptying; Severe allergy to skin adhesives; Any diagnosis of systemic autonomic dysfunction; Enteric feeding tubes; Parenteral nutrition; Untreated depression or suicidal thoughts; Pregnant/breastfeeding women; Extrinsic myopathy/neuropathy; Vagal nerve injury; GERD.