Back to results

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

Primary Purpose

Gastroparesis, Functional Dyspepsia, Healthy

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Transauricular Vagal Nerve Stimulation

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring vagal nerve stimulation, EGG, gastroparesis, functional dyspepsia, auricular, stanford, digestive, gastroenterology

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).
GERD.
History of dumping syndrome.
History of rapid gastric emptying.
Severe allergy to skin adhesives.
Concurrent enrollment in other clinical trials.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Gastroparesis

Functional Dsypepsia

Healthy Controls

Arm Description

Patients diagnosed with Gastroparesis.

Patients diagnosed with Functional Dsypepsia.

Healthy volunteers (without Functional Dsypepsia or Gastroparesis)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05405842

First Posted

May 23, 2022

Last Updated

January 25, 2023

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT05405842

Brief Title

Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis

Acronym

AVNS

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 2023 (Anticipated)

Primary Completion Date

May 2025 (Anticipated)

Study Completion Date

May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroparesis, Functional Dyspepsia, Healthy, Digestive System Disease, Gastroenterology

Keywords

vagal nerve stimulation, EGG, gastroparesis, functional dyspepsia, auricular, stanford, digestive, gastroenterology

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

n= 60 3 groups : gastroparesis (n=20); functional dyspepsia (n=20) ; health controls (n=20)

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gastroparesis

Arm Type

Experimental

Arm Description

Patients diagnosed with Gastroparesis.

Arm Title

Functional Dsypepsia

Arm Type

Experimental

Arm Description

Patients diagnosed with Functional Dsypepsia.

Arm Title

Healthy Controls

Arm Type

Experimental

Arm Description

Healthy volunteers (without Functional Dsypepsia or Gastroparesis)

Intervention Type

Device

Intervention Name(s)

Transauricular Vagal Nerve Stimulation

Other Intervention Name(s)

vagal nerve stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Establish EGG/HRV parameters and effects following taVNS

Description

Time Frame

3-5 years

Secondary Outcome Measure Information:

Title

Determine deviations in EGG/HRV parameters and effects following taVNS

Description

Time Frame

3-5 years

Other Pre-specified Outcome Measures:

Title

Determine Stimulation Parameters of tAVNS with Greater Effect on Gastroparesis and Functional Dyspepsia

Description

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.

Time Frame

3-5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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). GERD. History of dumping syndrome. History of rapid gastric emptying. Severe allergy to skin adhesives. Concurrent enrollment in other clinical trials.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Linda Nguyen, MD

Phone

(650)723-5135

nguyenLB@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wendy XY Zhou, DO

Organizational Affiliation

Fellow

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sandya Subramanian, Phd

Organizational Affiliation

Postdoctoral Fellow

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Todd Coleman, Phd

Organizational Affiliation

Associate Professor

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Linda Nguyen, MD

Organizational Affiliation

Clinical Professor of Medicine

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis

We'll reach out to this number within 24 hrs