Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome.

Stopped early · Not applicable · Has a placebo group

Conditions studied: Cyclic Vomiting Syndrome

In brief

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.

Key facts

Study ID
NCT04721171
Run by
Medical College of Wisconsin
People needed
4
Starts
2019-04-23
Expected to finish
2021-02-09
Last updated by the study team
2026-04-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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