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Device

nVNS (gammaCore) for Gastroparesis-Related Nausea (nVNS Trial)

N/A
Waitlist Available
Led By Jay Pasricha, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 and 6 weeks after nvns initiation
Awards & highlights

nVNS Trial Summary

This trial is testing whether a handheld device that sends electrical stimulation to the vagus nerve can relieve nausea, with the goal of providing a safer alternative to traditional rescue medications.

Who is the study for?
Adults with gastroparesis or chronic unexplained nausea and vomiting, experiencing moderate to severe symptoms. Participants must have a specific level of nausea documented and can only use certain anti-nausea medications up to four times daily. They cannot have other conditions that explain their symptoms, be pregnant or nursing, use narcotics frequently, have had certain gastrointestinal surgeries or heart issues, or possess any implanted electrical devices.Check my eligibility
What is being tested?
The trial is testing nVNS (gammaCore), a non-invasive device applied on the neck to stimulate the vagus nerve as an alternative treatment for nausea in gastroparesis patients. It aims to provide relief without the risks associated with invasive procedures like Gastric electrical stimulation (GES) and may reduce reliance on traditional rescue medications.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of nVNS typically include mild discomfort at the application site, headache, dizziness, or tingling sensation. Serious side effects are rare but could involve changes in blood pressure or heart rhythm.

nVNS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have ongoing moderate to severe nausea, vomiting, bloating, or abdominal pain.
Select...
You have symptoms that could be caused by a blockage in your digestive system or other stomach-related issues that are not under control.

nVNS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 and 6 weeks after nvns initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 and 6 weeks after nvns initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average daily use of rescue medications for exacerbation of nausea/vomiting.

nVNS Trial Design

1Treatment groups
Experimental Treatment
Group I: nVNS deviceExperimental Treatment1 Intervention
Candidates who, after the screening period are eligible to receive the nVNS device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nVNS (gammaCore)
2021
N/A
~50

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,242 Previous Clinical Trials
14,816,592 Total Patients Enrolled
11 Trials studying Gastroparesis
1,183 Patients Enrolled for Gastroparesis
ElectroCore INCIndustry Sponsor
30 Previous Clinical Trials
2,205 Total Patients Enrolled
Jay Pasricha, MDPrincipal InvestigatorJohns Hopkins School of Medicine
1 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Gastroparesis
250 Patients Enrolled for Gastroparesis

Media Library

nVNS (gammaCore) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04857281 — N/A
Gastroparesis Research Study Groups: nVNS device
Gastroparesis Clinical Trial 2023: nVNS (gammaCore) Highlights & Side Effects. Trial Name: NCT04857281 — N/A
nVNS (gammaCore) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04857281 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people fit the qualifications for this research project?

"That is accurate. The clinical trial, which was posted on 4/19/2021 and last updated on 3/8/2022, is still recruiting patients. Up to 45 participants are needed from 1 site."

Answered by AI

Are we enrolling people in this experiment at the moment?

"That is right, the online information from clinicaltrials.gov states that this research study is still looking for participants. The posting went up on April 19th 2021 and was updated as recently as March 8th of this year. So far, only 45 individuals have signed up at a single location."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
Colorado
Mississippi
How old are they?
65+
What site did they apply to?
Johns Hopkins Bayview Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I’ve tried many other medications and also the G-Poem procedure. I’m still having severe symptoms. Please help me!
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

~11 spots leftby Mar 2025