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Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis

NCT05405842 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-08-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Wendy XY Zhou, DO · Fellow

  • Sandya Subramanian, Phd · Postdoctoral Fellow

  • Todd Coleman, Phd · Associate Professor

  • Linda Nguyen, MD · Clinical Professor of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-01-31
Completion
2025-09-30
FDA Device
Yes

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05405842 on ClinicalTrials.gov