Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis (NCT03603730) | Clinical Trial Compass
RecruitingNot Applicable
Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
United States65 participantsStarted 2018-11-30
Plain-language summary
Explore the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach outcomes in functional dyspepsia and gastroparesis patients.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Volunteers, female and male, between 18 and 65 years of age.
. For healthy volunteers, ability to undergo MRI for up to 2 hours.
. For Functional Dyspeptic patients, diagnosis according to the Rome III criteria for both PDS and EPS subtypes.
. For Gastroparesis patients, diagnosis will include the following criteria:
Exclusion criteria
. History gastric/esophageal surgery
. Any alternative treatment (e.g. acupuncture, hypnosis etc.) two weeks prior to the study or during the study period.
. Illicit drugs or opioid use.
. History of arrhythmias.
. Implanted pacemaker.
. Epilepsy or a prior history of seizures.
. For Gastroparesis patients, inability to comply with or complete GES test (including allergy to eggs).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.