Chronic Unexplained Nausea and VomitingnVNSNCT04857281
Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders
A study testing nVNS (gammaCore) in people with Chronic Unexplained Nausea and Vomiting and Gastroparesis, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Unexplained Nausea and Vomiting, Gastroparesis
- What is being tested?
- nVNS (gammaCore)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 23 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
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.
Read the 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.
- Being tested
- nVNS (gammaCore)
- Medical subject headings
- Vomiting, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| nVNS device | Experimental | Candidates who, after the screening period are eligible to receive the nVNS device. Receives: Device: nVNS (gammaCore) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4, 6, 10 and 12 weeks of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start19 Apr 2021
- Primary completion31 Dec 2023
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Unexplained Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- ElectroCore INC
- Responsible party
- Sponsor
- Investigators
- Jay Pasricha, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857281
- Sponsor's protocol ID
- IRB00265410
- Acronym
- nVNS
- Status last verified
- Oct 2024
- First submitted
- 20 Apr 2021
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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. 2026 Mar;71(3):1003-1014. doi: 10.1007/s10620-025-09457-2. Epub 2025 Oct 16.
PubMed 41100038
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders
- ClinicalTrials.gov ID
- NCT04857281
- Acronym / sponsor ID
- nVNS / IRB00265410
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- ElectroCore INC
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nVNS device | Experimental | Device: nVNS (gammaCore)Candidates who, after the screening period are eligible to receive the nVNS device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | nVNS device |
Primary outcome
Average Daily Use of Rescue Medications for Exacerbation of Nausea/Vomiting.
Time frame: Baseline, 4, 6, 10 and 12 weeks of study participation
Average daily use of rescue medications for exacerbation of nausea/vomiting = sum of nausea medications / number of days with non-missing nausea medication data.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41100038Barahona 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. 2026 Mar;71(3):1003-1014. doi: 10.1007/s10620-025-09457-2. Epub 2025 Oct 16.
- Individual participant dataSharing planned: No
Related trials for Chronic Unexplained Nausea and Vomiting
Recruiting
Brain-Stomach Circuits in Chronic Nausea
Chronic Nausea and Vomiting Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Pasricha, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nVNS (gammaCore) in people with Chronic Unexplained Nausea and Vomiting and Gastroparesis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daily Use of Rescue Medications for Exacerbation of Nausea/Vomiting. (time frame: Baseline, 4, 6, 10 and 12 weeks of study participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04857281, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.