NCT04857281

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The patient will receive the gammaCore (nVNS) device and a video instruction will be use to explain how to properly handle the device. Treatment can only start after eligibility has been fully checked and all data collected at screening have been keyed into the trial database. 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.

Conditions

• Chronic Unexplained Nausea and Vomiting
• Gastroparesis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-19
• Primary completion: 2023-12-31
• Completion: 2024-01-23
• First posted: 2021-04-23
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study