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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2023
  • participants needed
    45
  • sponsor
    Johns Hopkins University
Updated on 5 May 2021

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.

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.

Details
Condition Gastroparesis, Gastroparesis, Diabetic Gastroparesis, Gastropathy, Stomach Discomfort, Stomach Discomfort, Diabetic Gastroparesis, delayed gastric emptying, gastric atony, Chronic Unexplained Nausea and Vomiting
Treatment nVNS (gammaCore)
Clinical Study IdentifierNCT04857281
SponsorJohns Hopkins University
Last Modified on5 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years or older at registration
Diagnosis of gastroparesis as documented by gastric emptying scintigraphy (4-hour emptying after a low-fat meal with any combination of 2- and 4-hour retention of >60% and 10%, respectively), or Chronic Unexplained Nausea and Vomiting (CUNV)
Ongoing symptoms (i.e. Nausea and vomiting, bloating, and abdominal pain) with a nausea score of 3 or more on the patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) scale at baseline (moderate to severe nausea)
Exclusion of other causes of symptoms such as mechanical gastrointestinal obstruction, uncontrolled esophagitis, peptic ulcer disease, etc. By standard radiographic or endoscopic tests
Use of the following medications on an as-needed basis: ondansetron, promethazine or prochlorperazine but no more than four times a day

Exclusion Criteria

Another active disorder, which could explain symptoms in the opinion of the investigator
Age < than 18 years
Pregnancy or nursing
A previous surgery of the upper gastrointestinal tract, including vagotomy
Use of narcotics more than 3 days per week
History of prolonged QT interval or a history of clinically significant arrhythmia
Abnormal baseline ECG (e.g. Second- and third-degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction)
Previous bilateral or right cervical vagotomy
Uncontrolled high blood pressure
Currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
History of carotid endarterectomy or vascular neck surgery on the right side
Implanted with metal cervical spine hardware or has a metallic implant near the gammaCore stimulation site
Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
Failure to give informed consent
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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