Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis

Healthy Clinical Trial

— AVNS  

Official title:

Effects of Transauricular Vagal Nerve Stimulation on Electrogastrography (EGG) and Heart Rate Variability (HRV) in Healthy Subjects, Functional Dyspepsia, and Gastroparesis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05405842
• Other study ID #: 63421
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: May 2025

Study information

• Verified date: January 2023
• Source: Stanford University
• Contact: Linda Nguyen, MD
• Phone: (650)723-5135
• Email: nguyenLB[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Disease
• Digestive System Diseases
• Dyspepsia
• Functional Dyspepsia
• Gastroenterology
• Gastrointestinal Diseases
• Gastroparesis
• Healthy

Intervention

Device:
• Transauricular Vagal Nerve Stimulation
TENS 7000 is a handheld device used to deliver electrical impulses for nerve stimulation to help modulate and treat chronic pain. The manufacturer, Roscoe, has regulatory approval for the use of nerve stimulator therapy in the acute and/or prophylactic treatment of headaches, migraines, sciatica, muscle spasms, acute and chronic pain, and improve circulation. It is FDA approved in the USA for the above indications, but has not been approved for use in gastrointestinal diseases such as gastroparesis or functional dyspepsia. It has been registered as an investigational new device in various clinical trials. The purpose of this protocol is to provide vagal nerve stimulation to patients with gastroparesis, functional dyspepsia, and healthy controls as a comparison.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determine Stimulation Parameters of tAVNS with Greater Effect on Gastroparesis and Functional Dyspepsia	To determine what stimulation parameters have a greater effect on EGG variables (gastric slow wave power, propagation, and phase gradient directionality,) and HRV variables (mean HR, mean RR, LF, HF) in gastroparesis and functional dyspepsia patients.	3-5 years
Primary	Establish EGG/HRV parameters and effects following taVNS	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.	3-5 years
Secondary	Determine deviations in EGG/HRV parameters and effects following taVNS	To determine if gastroparesis or functional dyspepsia patients have significant deviations in EGG (slow wave power, propagation, and phase gradient directionality) and HRV (mean HR, LF, HF, mean RR) parameters at baseline and following tAVNS compared to healthy volunteers.	3-5 years