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

NCT04857281 | Completed Results FDA Device

• 1 other identifier: IRB00265410
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Unexplained Nausea and Vomiting; Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Average Daily Use of Rescue Medications for Exacerbation of Nausea/Vomiting.

  Average daily use of rescue medications for exacerbation of nausea/vomiting = sum of nausea medications / number of days with non-missing nausea medication data.

  Baseline, 4, 6, 10 and 12 weeks of study participation

Study Arms (1)

nVNS device

EXPERIMENTAL

Candidates who, after the screening period are eligible to receive the nVNS device.

Device: nVNS (gammaCore)

Interventions

nVNS (gammaCore) DEVICE

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.

nVNS device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Use of the following medications on an as-needed basis: ondansetron, promethazine or prochlorperazine but no more than four times a day.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• ElectroCore INC: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Barahona G, de Barahona LV, Sidhu SS, Burns R, McKnight M, Hui KY, Bulat R, Treisman GJ, Liebler E, McClure CK, Pasricha PJ. Non-invasive Vagal Nerve Stimulation Decreases the Need for Rescue Medication for Nausea Exacerbation in Patients with Chronic Nausea and Vomiting. Dig Dis Sci. 2025 Oct 16. doi: 10.1007/s10620-025-09457-2. Online ahead of print.

  PMID: 41100038 DERIVED

MeSH Terms

Conditions

Vomiting; Gastroparesis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations

Results Point of Contact

• Title: Dr. Jay Pasricha
• Organization: Mayo Clinic Arizona

pasricha.jay@mayo.edu

(480)301-4279

Study Officials

• Jay Pasricha, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: April 19, 2021
• Primary Completion: December 31, 2023
• Study Completion: January 23, 2024
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)