Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis (AVNS)

Stanford University

Status: Not yet enrolling

Conditions: Healthy; Functional Dyspepsia; Gastroparesis; Gastroenterology; Digestive System Disease

Treatments: Device: Transauricular Vagal Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05405842

63421

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Gastroparesis

Experimental group

Description:

Patients diagnosed with Gastroparesis.

Treatment:

Device: Transauricular Vagal Nerve Stimulation

Functional Dsypepsia

Experimental group

Description:

Patients diagnosed with Functional Dsypepsia.

Treatment:

Device: Transauricular Vagal Nerve Stimulation

Healthy Controls

Experimental group

Description:

Healthy volunteers (without Functional Dsypepsia or Gastroparesis)

Treatment:

Device: Transauricular Vagal Nerve Stimulation