NCT04721171

Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome.

Terminated NA Results posted Last updated 2 April 2026

What this trial tests

NA trial testing The Bridge device in Cyclic Vomiting Syndrome in 4 participants. Terminated before completion.

Timeline

23 April 2019

Primary endpoint
1 February 2020

9 February 2021

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	triple
Primary purpose	treatment
Enrollment	4
Start date	23 April 2019
Primary completion	1 February 2020
Estimated completion	9 February 2021
Sites	1 location across United States

Drugs / interventions tested

• The Bridge device

Conditions studied

• Cyclic Vomiting Syndrome — all drugs for Cyclic Vomiting Syndrome →

Sponsor

Medical College of Wisconsin

Who can join

Adults 18 to 65, any sex, with Cyclic Vomiting Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

We hypothesize that 1) Neurostimulation via a novel auricular percutaneous electrical nerve field stimulation (PENFS) device is a safe, non-invasive opioid-sparing alternative therapy for severe abdominal pain, nausea, and vomiting associated with CVS and will reduce the need for opioids. We also hypothesize that 2) PENFS reduces the length of stay (LOS), and improves patient satisfaction. We propose the following specific aim:

Aim 1. Investigate the efficacy of PENFS compared to a sham in patients with CVS seen in the ED or in the clinic or hospitalized with an acute CVS episode.

Objectives:

1. Demonstrate reduction in abdominal pain, nausea, and vomiting using validated tools.
2. Obviate or reduce the need for opioids.
3. Reduce the length of hospital stay and improve patient satisfaction.

This approach will specifically address the current opioid problem using a novel, non-invasive neurostimulation therapy with proven efficacy for opioid withdrawal. Long-term, it may improve health care outcomes and significantly reduce overall health care costs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.