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

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ClinicalTrials.gov Identifier: NCT04857281
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 26, 2021
Sponsor:
Collaborator:
ElectroCore INC
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Unexplained Nausea and Vomiting Gastroparesis Device: nVNS (gammaCore) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders
Actual Study Start Date : April 19, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : January 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: nVNS device
Candidates who, after the screening period are eligible to receive the nVNS device.
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.




Primary Outcome Measures :
  1. Average daily use of rescue medications for exacerbation of nausea/vomiting. [ Time Frame: 4 and 6 weeks after nVNS initiation ]
    Frequency of daily use of rescue medications.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857281


Contacts
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Contact: Pankaj J Pasricha, MD 4105501793 pasricha@jhu.edu
Contact: Guillermo A Barahona, MD 4105508871 gbaraho1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Pankaj Pasricha, MD    410-550-1793    pasricha@jhu.edu   
Contact: Guillermo Barahona, MD    4106038343    gbaraho1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
ElectroCore INC
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04857281    
Other Study ID Numbers: IRB00265410
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Gastroparesis
Nausea
Vomiting
Signs and Symptoms, Digestive
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations