Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis

NCT05405842 | Withdrawn FDA Device

• 1 other identifier: 63421
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine deviations in EGG/HRV parameters and effects following taVNS

  3-5 years

Other Outcomes (1)

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

  3-5 years

Study Arms (3)

Gastroparesis

EXPERIMENTAL

Patients diagnosed with Gastroparesis.

Device: Transauricular Vagal Nerve Stimulation

Functional Dsypepsia

EXPERIMENTAL

Patients diagnosed with Functional Dsypepsia.

Device: Transauricular Vagal Nerve Stimulation

Healthy Controls

EXPERIMENTAL

Healthy volunteers (without Functional Dsypepsia or Gastroparesis)

Device: Transauricular Vagal Nerve Stimulation

Interventions

Transauricular Vagal Nerve Stimulation DEVICE

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.

Also known as: vagal nerve stimulation

Functional Dsypepsia; Gastroparesis; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Gastroparesis; Digestive System Diseases

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Wendy XY Zhou, DO

  Fellow

  STUDY DIRECTOR

• Sandya Subramanian, Phd

  Postdoctoral Fellow

  PRINCIPAL INVESTIGATOR

• Todd Coleman, Phd

  Associate Professor

  PRINCIPAL INVESTIGATOR

• Linda Nguyen, MD

  Clinical Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine

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

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 6, 2022
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share