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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 and 6 weeks after nvns initiation
Awards & highlights
Summary
This trial tests a handheld device that sends gentle electrical pulses to the neck to help reduce severe nausea by activating the vagus nerve. It offers a safer alternative to traditional medications and invasive treatments. Non-invasive vagus nerve stimulation (VNS) has shown beneficial effects in treating conditions like epilepsy, depression, and headaches.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 and 6 weeks after nvns initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 and 6 weeks after nvns initiation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Average daily use of rescue medications for exacerbation of nausea/vomiting.
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
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,864 Total Patients Enrolled
11 Trials studying Gastroparesis
1,183 Patients Enrolled for Gastroparesis
ElectroCore INCIndustry Sponsor
30 Previous Clinical Trials
2,157 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allowed to take ondansetron, promethazine, or prochlorperazine up to four times a day as needed.You have ongoing moderate to severe nausea, vomiting, bloating, or abdominal pain.You have conditions like blockages in your intestines or uncontrolled esophagitis that are causing symptoms, and these have been confirmed by standard tests like X-rays or endoscopies.You have ongoing moderate to severe nausea, vomiting, bloating, or abdominal pain.You have symptoms that could be caused by a blockage in your digestive system or other stomach-related issues that are not under control.You have another health condition that could be causing your symptoms, according to the doctor.You have had surgery on your upper digestive system, like the stomach or esophagus, including vagotomy.You use strong pain medications more than three days a week.You have a history of heart rhythm problems.Your initial ECG shows certain irregular heartbeats or rhythms.You have had surgery on the right side of your neck's blood vessels.You have metal implants in your neck or near the area where the gammaCore device is used.You have been diagnosed with gastroparesis or chronic unexplained nausea and vomiting.You have had surgery to cut the nerves in your neck.Your high blood pressure is not under control.You currently have a device implanted in your body that sends electrical signals, like a pacemaker or neurostimulator.You have been diagnosed with gastroparesis or chronic unexplained nausea and vomiting.
Research Study Groups:
This trial has the following groups:- Group 1: nVNS device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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