At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders
In Brief
A clinical study evaluating nVNS (gammaCore) for Chronic Unexplained Nausea and Vomiting and Gastroparesis. Completed, enrolled 49 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.