Status:
WITHDRAWN
Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis
Lead Sponsor:
Stanford University
Conditions:
Gastroparesis
Functional Dyspepsia
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 f...
Detailed Description
This is a prospective pilot study assessing the relationship of electrogastrography and heart rate variability, with transauricular stimulation of the vagal nerve in healthy subjects compared to gastr...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Any diagnosis of systemic autonomic dysfunction.
- Use of narcotic, anticholinergic, cholinergic, or promotility medications in preceding 2 weeks of study.
- Enteric feeding tubes.
- Parenteral nutrition.
- Severe disease flare requiring hospitalization or ER visits within 3 months of study.
- Untreated depression or suicidal thoughts.
- Pregnant/breastfeeding women.
- History of gastric pacemaker implantation.
- Implantable electronic devices (i.e. cardiac pacemakers)
- Extrinsic myopathy/neuropathy
- Vagal nerve injury.
- High risk cardiac arrhythmias (high grade AV block, atrial fibrillation, atrial flutter).
- GERD.
- History of dumping syndrome.
- History of rapid gastric emptying.
- Severe allergy to skin adhesives.
- Concurrent enrollment in other clinical trials.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05405842
Start Date
January 1 2024
End Date
September 1 2025
Last Update
August 3 2025
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