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Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders | Clinical Trials | Clareo Health

COMPLETEDNA

Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders

NCT04857281•Johns Hopkins University

View on ClinicalTrials.gov

Summary

The hypothesis of this pilot study is that nVNS will result in relief of nausea by modulation of vagal nerve activity. nVNS is the first non-invasive, handheld medical device applied on the side of the neck and sends gentle, patented mild electrical stimulation through the skin to activate the vagus nerve. nVNS offers a potential alternative to Gastric electrical stimulation (GES) that could eliminate significant risks of injury or illness or identify likely responders to implantable neurostimulator including implanted VNS (iVNS). nVNS could provide a more effective and safer alternative to the use of traditional rescue medications.

Detailed Description

The patient will receive the gammaCore (nVNS) device and a video instruction will be use to explain how to properly handle the device. Treatment can only start after eligibility has been fully checked and all data collected at screening have been keyed into the trial database. The patient will be instructed to use the nVNS in place of the rescue medications. When the nauseas gets bad enough that they feel to use a rescue medication they will first use the device on one side of the neck for two 2-minute stimulations and wait fifteen minutes to check if the stimulation works. If this does not help either, they will stimulate with an additional 2 stimulations and wait for another fifteen minutes. If there is no improvement rescue medication will be used. nVNS can be used up to, but no more than, 8 times a day.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 18 years or older at registration.
•Diagnosis of gastroparesis as documented by gastric emptying scintigraphy (4-hour emptying after a low-fat meal with any combination of 2- and 4-hour retention of \>60% and 10%, respectively), or Chronic Unexplained Nausea and Vomiting (CUNV).
•Ongoing symptoms (i.e. Nausea and vomiting, bloating, and abdominal pain) with a nausea score of 3 or more on the patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) scale at baseline (moderate to severe nausea).
•Exclusion of other causes of symptoms such as mechanical gastrointestinal obstruction, uncontrolled esophagitis, peptic ulcer disease, etc. By standard radiographic or endoscopic tests.
•Use of the following medications on an as-needed basis: ondansetron, promethazine or prochlorperazine but no more than four times a day.

Exclusion Criteria

•Another active disorder, which could explain symptoms in the opinion of the investigator.
•Age \< than 18 years.
•Pregnancy or nursing.
•A previous surgery of the upper gastrointestinal tract, including vagotomy.
•Use of narcotics more than 3 days per week.
•History of prolonged QT interval or a history of clinically significant arrhythmia.
•Abnormal baseline ECG (e.g. Second- and third-degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction).
•Previous bilateral or right cervical vagotomy.
•Uncontrolled high blood pressure.
•Currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
+4 more criteria

Locations (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Key Dates

Start Date

April 19, 2021

Primary Completion Date

December 31, 2023

Completion Date

January 23, 2024

Last Updated

October 15, 2024

Enrollment

ACTUAL participants

Conditions

Chronic Unexplained Nausea and VomitingGastroparesis

Interventions

nVNS (gammaCore)

DEVICE

Gastroparesis Outcome Longitudinal Database Enrolled Numerically

NCT03876288

Gastroparesis

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RECRUITINGEARLY_PHASE1

Growth Hormone for the Treatment of Gastroparesis

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RECRUITINGNA

Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders

Inclusion Criteria

Exclusion Criteria

Gastroparesis Outcome Longitudinal Database Enrolled Numerically

Growth Hormone for the Treatment of Gastroparesis

Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes

Transpyloric Stenting As a Predictor for G-POEM for Refractory Gastroparesis

Different Doses of Naronapride Vs. Placebo in Gastroparesis

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