Status:
COMPLETED
Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
ElectroCore INC
Conditions:
Chronic Unexplained Nausea and Vomiting
Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2024
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04857281
Start Date
April 19 2021
End Date
January 23 2024
Last Update
October 15 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224