Effects of Transauricular Vagal Nerve Stimulation on Electrogastrography (EGG) and Heart Rate Variability (HRV) in Healthy Subjects, Functional Dyspepsia, and Gastroparesis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Stanford University
- Enrollment
- 60
- Primary Endpoint
- Establish EGG/HRV parameters and effects following taVNS
Study Overview
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 functional dyspepsia, at baseline and following taVNS.
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 gastroparesis and functional dyspepsia patients. The investigators plan to recruit a total of 60 patients: 20 healthy volunteers, 20 gastroparesis, and 20 functional dyspepsia patients. Participants will undergo two testing sessions in which electrogastrography (EGG) and heart rate variability (HRV) will be measured using electrodes following transauricular vagal nerve stimulation (tAVNS) at various frequencies.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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).
- •History of dumping syndrome.
- •History of rapid gastric emptying.
- •Severe allergy to skin adhesives.
- •Concurrent enrollment in other clinical trials.
Outcomes
Primary Outcomes
Establish EGG/HRV parameters and effects following taVNS
Time Frame: 3-5 years
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.
Secondary Outcomes
- Determine deviations in EGG/HRV parameters and effects following taVNS(3-5 years)
Investigators
Linda Nguyen
Clinical Professor of Medicine
Stanford University