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| Name | Class |
|---|---|
| ElectroCore INC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nVNS device | Experimental | Candidates who, after the screening period are eligible to receive the nVNS device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Pasricha, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41100038 | Derived | 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. |
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After meeting the criteria, patients underwent a 7-day screening to establish baseline symptoms and nausea medication intake. Subjects were then randomly assigned to use the nVNS device on one side of the neck for 4 weeks. This was followed by a 2-week washout period before switching to the opposite side, with an additional 2-week washout at the end.
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| ID | Title | Description |
|---|---|---|
| FG000 | nVNS Was First Applied to One Side of the Neck, Followed by Stimulation on the Opposite Side. | After meeting the criteria, patients underwent a 7-day screening to establish baseline symptoms and nausea medication intake. Candidates who were eligible after the screening were then randomly assigned to use the nVNS (gammaCore) device on one side of the neck for 4 weeks, followed by a 2-week washout period before switching to the opposite side, with an additional 2-week washout at the end. Eight subjects were excluded before starting nVNS due to missing baseline information on symptoms and nausea medication intake. The treatment with nVNS will be self-administered for 4 weeks, with proper training provided by a study member on the correct use of the device. Patients will be instructed to use nVNS instead of rescue medications. When nausea becomes severe, patients will first apply two 2-minute stimulations on one side of the neck and wait 15 minutes to assess its effectiveness. If the nausea persists, they will apply an additional two stimulations and wait another 15 minutes. If there is still no improvement, they may use rescue medication. nVNS can be used up to 8 times per day, but no more. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2022 |
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| COMPLETED |
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| NOT COMPLETED |
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| First Intervention - 4 Weeks |
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| First Washout - 2 Weeks |
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| Second Intervention - 4 Weeks |
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| Second Washout - 2 Weeks |
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| ID | Title | Description |
|---|---|---|
| BG000 | nVNS Was First Applied to One Side of the Neck, Followed by Stimulation on the Opposite Side. | After meeting the criteria, patients underwent a 7-day screening to establish baseline symptoms and nausea medication intake. Candidates who were eligible after the screening were then randomly assigned to use the nVNS (gammaCore) device on one side of the neck for 4 weeks, followed by a 2-week washout period before switching to the opposite side, with an additional 2-week washout at the end. Eight subjects were excluded before starting nVNS due to missing baseline information on symptoms and nausea medication intake. The treatment with nVNS will be self-administered for 4 weeks, with proper training provided by a study member on the correct use of the device. Patients will be instructed to use nVNS instead of rescue medications. When nausea becomes severe, patients will first apply two 2-minute stimulations on one side of the neck and wait 15 minutes to assess its effectiveness. If the nausea persists, they will apply an additional two stimulations and wait another 15 minutes. If there is still no improvement, they may use rescue medication. nVNS can be used up to 8 times per day, but no more. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Inter-Quartile Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis included only participants who completed each study intervention. | Posted | Least Squares Mean | 95% Confidence Interval | medications/day | Baseline, 4, 6, 10 and 12 weeks of study participation |
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Up to 13 weeks
Serious Adverse Events and All-cause mortality were not collected for any participant. Other not serious adverse events were not collected for eight subjects who were excluded before starting nVNS.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | nVNS Device | Candidates who, after the screening period are eligible to receive the nVNS device. 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. | 0 | 0 | 0 | 0 | 1 | 41 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jay Pasricha | Mayo Clinic Arizona | (480)301-4279 | pasricha.jay@mayo.edu |
| Sep 10, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 18, 2022 | Sep 10, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Second Side (10 Weeks Follow-up) |
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| Final Wash Out (12 Weeks Follow-up) |
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