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

NACompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

April 19, 2021

Primary Completion Date

December 31, 2023

Study Completion Date

January 23, 2024

Conditions
Chronic Unexplained Nausea and VomitingGastroparesis
Interventions
DEVICE

nVNS (gammaCore)

The treatment will be self-administered using nVNS and will be applied for 4 weeks; a member of the study will provide the proper training on the correct use of nVNS. 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.

Trial Locations (1)

21224

Johns Hopkins Bayview Medical Center, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ElectroCore INC

INDUSTRY

lead

Johns Hopkins University

OTHER

NCT04857281 - Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders | Biotech Hunter | Biotech Hunter