What side effects are associated with this type of intervention?

Common treatments for gastroparesis that involve electrical stimulation, such as gastric electrical stimulation and transcutaneous electrical nerve stimulation, generally have mild side effects. These can include sensations of warmth, numbness, redness, itching, tingling, muscle spasms, and localized pain in areas such as the arm, shoulder, or neck. Serious adverse events are rare. For instance, gastric electrical stimulation has shown efficacy in improving gastric emptying and reducing symptoms, but it may cause mild discomfort at the implantation site. Similarly, transcutaneous electrical nerve stimulation is associated with mild device-related side effects but no serious adverse events.

What prior FDA approvals exist?

FDA-approved treatments for gastroparesis include medications like erythromycin and metoclopramide, which enhance gastric motility. Erythromycin acts as a motilin receptor agonist, while metoclopramide is a dopamine antagonist that also has prokinetic effects. Although auricular transcutaneous vagal nerve stimulation (taVNS) is being studied for its potential to improve gastrointestinal motility by stimulating the vagus nerve, there is no specific mention of FDA approval for this type of neuromodulation therapy for gastroparesis in the provided context. Current FDA-approved treatments focus primarily on pharmacological agents rather than neuromodulation techniques.

What other types of research exist?

Promising, novel alternatives to Auricular Transcutaneous Vagal Nerve Stimulation (taVNS) for Gastroparesis patients include Transcutaneous Supraorbital Nerve Stimulation and Transcutaneous Electrical Nerve Stimulation (TENS). These methods have shown efficacy in reducing pain and improving gastrointestinal symptoms without major adverse events.

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Vagus Nerve Stimulator

Vagal Nerve Stimulation for Indigestion and Gastroparesis

Q: What is the mechanism of action of this treatment?

Common treatments for gastroparesis include gastric electrical stimulation, pyloroplasty, and vagal nerve stimulation. Gastric electrical stimulation uses electrical pulses to enhance gastric motility and improve symptoms like nausea and vomiting. Pyloroplasty involves surgical modification of the pylorus to facilitate gastric emptying. Vagal nerve stimulation, including auricular transcutaneous vagal nerve stimulation (taVNS), targets the vagus nerve to improve gastrointestinal motility and brain-gut communication. These treatments are crucial for gastroparesis patients as they address the underlying motility issues, thereby reducing symptoms and improving quality of life.

Phase < 1

Recruiting

Led By Vitaly Napadow, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Functional Dyspeptic patients, diagnosis according to the Rome III criteria for both PDS and EPS subtypes.

an idiopathic etiology

Must not have

History of arrhythmias

History gastric/esophageal surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 40 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a treatment that sends mild electrical pulses to the outer ear to help people with stomach issues like functional dyspepsia and gastroparesis. The goal is to see if this can improve communication between the brain and stomach and reduce symptoms. Gastric electrical stimulation (GES) has been proposed as an effective treatment option for patients with gastroparesis that does not respond to other treatments.

Who is the study for?

This trial is for adults aged 18-65 with gastroparesis or functional dyspepsia, diagnosed by specific criteria and tests. Participants must have stable medical treatment for a month prior to and during the study, no history of gastric surgery, arrhythmias, seizures, drug abuse or BMI over 32. They can't be pregnant/nursing or planning pregnancy.

What is being tested?

The trial studies auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach in patients with indigestion issues like gastroparesis and functional dyspepsia. It aims to understand how taVNS affects these conditions.

What are the potential side effects?

Potential side effects of taVNS may include discomfort at the stimulation site, headache, lightheadedness or fainting. Since it's non-invasive, serious side effects are less common but could involve changes in heart rate or blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Functional Dyspepsia as per Rome III criteria.

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My condition has no known cause.

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I have been diagnosed with Functional Dyspepsia as per Rome III criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of irregular heartbeats.

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I have had surgery on my stomach or esophagus.

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I have epilepsy or have had seizures before.

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My BMI is over 32 or my weight is more than 235 lbs.

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I cannot have an MRI due to metal in my body, recent surgery, or severe claustrophobia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 40 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~40 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neuroimaging

Secondary study objectives

Electrocardiography (ECG)

Electrogastrography (EGG)

Respiration

+1 more

Other study objectives

Brief Pain Inventory (BPI)

Liquid meal challenge

Short Form Nepean Dyspepsia Index (SF-NDI)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: taVNSExperimental Treatment1 Intervention

Active or inactive taVNS

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

taVNS

2011

Completed Phase 4

~330

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gastroparesis include gastric electrical stimulation, pyloroplasty, and vagal nerve stimulation. Gastric electrical stimulation uses electrical pulses to enhance gastric motility and improve symptoms like nausea and vomiting. Pyloroplasty involves surgical modification of the pylorus to facilitate gastric emptying. Vagal nerve stimulation, including auricular transcutaneous vagal nerve stimulation (taVNS), targets the vagus nerve to improve gastrointestinal motility and brain-gut communication. These treatments are crucial for gastroparesis patients as they address the underlying motility issues, thereby reducing symptoms and improving quality of life.

Transcutaneous auricular vagus nerve stimulation influences gastric motility: A randomized, double-blind trial in healthy individuals.Non-invasive stimulation of vagal afferents reduces gastric frequency.