Back to resultsNon-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders (nVNS)
Primary Purpose
Chronic Unexplained Nausea and Vomiting, Gastroparesis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nVNS (gammaCore)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Unexplained Nausea and Vomiting
Eligibility 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.
Sites / Locations
- Johns Hopkins Bayview Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nVNS device
Arm Description
Candidates who, after the screening period are eligible to receive the nVNS device.
Outcomes
Primary Outcome Measures
Average daily use of rescue medications for exacerbation of nausea/vomiting.
Frequency of daily use of rescue medications.
Secondary Outcome Measures
Full Information
NCT ID
NCT04857281
First Posted
April 20, 2021
Last Updated
March 27, 2023
Sponsor
Johns Hopkins University
Collaborators
ElectroCore INC
1. Study Identification
Unique Protocol Identification Number
NCT04857281
Brief Title
Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders
Acronym
nVNS
Official Title
Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
ElectroCore INC
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Unexplained Nausea and Vomiting, Gastroparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nVNS device
Arm Type
Experimental
Arm Description
Candidates who, after the screening period are eligible to receive the nVNS device.
Intervention Type
Device
Intervention Name(s)
nVNS (gammaCore)
Intervention Description
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 Measure Information:
Title
Average daily use of rescue medications for exacerbation of nausea/vomiting.
Description
Frequency of daily use of rescue medications.
Time Frame
4 and 6 weeks after nVNS initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Pasricha, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders
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