AVNS: Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05405842

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis Functional Dyspepsia Healthy Digestive System Disease Gastroenterology	Device: Transauricular Vagal Nerve Stimulation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gastroparesis Patients diagnosed with Gastroparesis.	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. Other Names: vagal nerve stimulation
Experimental: Functional Dsypepsia Patients diagnosed with Functional Dsypepsia.	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. Other Names: vagal nerve stimulation
Experimental: Healthy Controls Healthy volunteers (without Functional Dsypepsia or Gastroparesis)	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. Other Names: vagal nerve stimulation

Arm

Intervention/Treatment

Experimental: Gastroparesis

Patients diagnosed with Gastroparesis.

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.

Other Names:

vagal nerve stimulation

Experimental: Functional Dsypepsia

Patients diagnosed with Functional Dsypepsia.

Device: Transauricular Vagal Nerve Stimulation

Other Names:

vagal nerve stimulation

Experimental: Healthy Controls

Healthy volunteers (without Functional Dsypepsia or Gastroparesis)

Device: Transauricular Vagal Nerve Stimulation

Other Names:

vagal nerve stimulation

Outcome Measures

Primary Outcome Measures

Establish EGG/HRV parameters and effects following taVNS [3-5 years]
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 [3-5 years]
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.

Other Outcome Measures

Determine Stimulation Parameters of tAVNS with Greater Effect on Gastroparesis and Functional Dyspepsia [3-5 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.