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
Sponsored by
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
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
Experimental
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
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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
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
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.
Time Frame
3-5 years
Secondary Outcome Measure Information:
Title
Determine deviations in EGG/HRV parameters and effects following taVNS
Description
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.
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
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
Email
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
No
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Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis
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