Trial Outcomes & Findings for Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders (NCT NCT04857281)
NCT ID: NCT04857281
Last Updated: 2024-10-15
Results Overview
Average daily use of rescue medications for exacerbation of nausea/vomiting = sum of nausea medications / number of days with non-missing nausea medication data.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
Baseline, 4, 6, 10 and 12 weeks of study participation
Results posted on
2024-10-15
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
First Intervention - 4 Weeks
COMPLETED
|
41
|
|
First Intervention - 4 Weeks
NOT COMPLETED
|
0
|
|
First Washout - 2 Weeks
STARTED
|
41
|
|
Baseline
STARTED
|
49
|
|
Baseline
COMPLETED
|
41
|
|
Baseline
NOT COMPLETED
|
8
|
|
First Intervention - 4 Weeks
STARTED
|
41
|
|
First Washout - 2 Weeks
COMPLETED
|
41
|
|
First Washout - 2 Weeks
NOT COMPLETED
|
0
|
|
Second Intervention - 4 Weeks
STARTED
|
41
|
|
Second Intervention - 4 Weeks
COMPLETED
|
41
|
|
Second Intervention - 4 Weeks
NOT COMPLETED
|
0
|
|
Second Washout - 2 Weeks
STARTED
|
41
|
|
Second Washout - 2 Weeks
COMPLETED
|
41
|
|
Second Washout - 2 Weeks
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders
Baseline characteristics by cohort
| Measure |
nVNS Was First Applied to One Side of the Neck, Followed by Stimulation on the Opposite Side.
n=49 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
34 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4, 6, 10 and 12 weeks of study participationPopulation: The analysis included only participants who completed each study intervention.
Average daily use of rescue medications for exacerbation of nausea/vomiting = sum of nausea medications / number of days with non-missing nausea medication data.
Outcome measures
| Measure |
nVNS Was First Applied to One Side of the Neck, Followed by Stimulation on the Opposite Side.
n=41 Participants
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.
|
|---|---|
|
Average Daily Use of Rescue Medications for Exacerbation of Nausea/Vomiting.
First Side (4 Weeks Follow-up)
|
0.551 medications/day
Interval 0.327 to 0.776
|
|
Average Daily Use of Rescue Medications for Exacerbation of Nausea/Vomiting.
Baseline
|
1.186 medications/day
Interval 0.675 to 1.696
|
|
Average Daily Use of Rescue Medications for Exacerbation of Nausea/Vomiting.
Wash Out (6 Weeks Follow-up)
|
0.754 medications/day
Interval 0.439 to 1.07
|
|
Average Daily Use of Rescue Medications for Exacerbation of Nausea/Vomiting.
Second Side (10 Weeks Follow-up)
|
0.447 medications/day
Interval 0.221 to 0.673
|
|
Average Daily Use of Rescue Medications for Exacerbation of Nausea/Vomiting.
Final Wash Out (12 Weeks Follow-up)
|
0.537 medications/day
Interval 0.183 to 0.892
|
Adverse Events
nVNS Device
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
nVNS Device
n=41 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin rash
|
2.4%
1/41 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place