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

Recruiting in Palo Alto (17 mi)

Overseen byJay Pasricha, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Age 18 years or older at registration.

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.

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Exclusion Criteria

Age < than 18 years

Pregnancy or nursing

You have another health condition that could be causing your symptoms, according to the doctor.

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Treatment Details

Interventions

nVNS (gammaCore) (Device)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: nVNS deviceExperimental Treatment1 Intervention

Candidates who, after the screening period are eligible to receive the nVNS device.