N/A
N=49
Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders
Chronic Unexplained Nausea and Vomiting · Gastroparesis
Bottom Line
View on ClinicalTrials.gov: NCT04857281 ↗Enrolled (actual)
49
Serious AEs
—
Results posted
Oct 2024
Primary outcome: Primary: Average Daily Use of Rescue Medications for Exacerbation of Nausea/Vomiting. — 1.186; 0.551; 0.754; 0.447 medications/day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- nVNS (gammaCore) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Daily Use of Rescue Medications for Exacerbation of Nausea/Vomiting. |
1.186; 0.551; 0.754; 0.447; 0.537 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04857281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.