Clinical trial NCT05405842: Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis
Official title: Effects of Transauricular Vagal Nerve Stimulation on Electrogastrography (EGG) and Heart Rate Variability (HRV) in Healthy Subjects, Functional Dyspepsia, and Gastroparesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroparesis
Functional Dyspepsia
Healthy
Digestive System Disease
Gastroenterology
Keywords: vagal nerve stimulation
EGG
gastroparesis
functional dyspepsia
auricular
stanford
digestive
gastroenterology
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: n= 60 3 groups : gastroparesis (n=20); functional dyspepsia (n=20) ; health controls (n=20)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Establish EGG/HRV parameters and effects following taVNS
timeFrame: 3-5 years
Secondary outcomes:
measure: Determine deviations in EGG/HRV parameters and effects following taVNS
timeFrame: 3-5 years
Other outcomes:
measure: Determine Stimulation Parameters of tAVNS with Greater Effect on Gastroparesis and Functional Dyspepsia
timeFrame: 3-5 years
Locations:
Study officials:
affiliation: Fellow
name: Wendy XY Zhou, DO
role: STUDY_DIRECTOR
affiliation: Postdoctoral Fellow
name: Sandya Subramanian, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor
name: Todd Coleman, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Professor of Medicine
name: Linda Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: