Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activ… (NCT06783504) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2
United States60 participantsStarted 2027-02-10
Plain-language summary
The purpose of this study is to find out if we can stimulate the vagus nerve. The vagus nerve is a largely internal nerve that controls many bodily functions, including stomach function. We hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function.
Who can participate
Age range
18 Years – 60 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:
* Wiling to have one teaspoon (5 ml) of blood drawn.
* Diagnosed with gastroparesis for twelve months or longer
* Diagnosed with diabetes either Type 1 or Type 2
* Documented delayed gastric emptying (\>10% retention of the test meal at four hours) on a standardized scrambled-egg scintigraphy gastric emptying test performed in the last two years.
* Upper GI endoscopy indicating no mechanical obstruction performed in the last five years.
* Symptoms of nausea and vomiting consistent with clinical diagnosis of gastroparesis (as opposed to other causes of nausea and vomiting such as mechanical obstruction, acute viral illness, chemotherapy, psychogenic vomiting.
* Documented Hb A1c within three months of screening or at the time of screening (\<=8.0)
Exclusion Criteria:
* Unable to provide consent
* Pregnant females
* Medical records indicate intestinal pseudo-obstruction
* Diagnosed with cardiac arrhythmia
* History of prior gastric surgery
* History of vagotomy
* History of organ transplantation
* History of seizures
* Diagnosed with primary swallowing disorders
* Subjects who are dependent on drugs like Marinol for their condition
* Those diagnosed with psychogenic vomiting and not related to gastroparesis
* Medically unstable subjects
* Those at high surgical risk
* Subjects taking narcotic analgesics daily.
* Those with poorly controlled diabetes mellitus (Hgb A1c\>8) within three months of screening or at the time of screening.
* Subjects diagnosed wi…
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.
What they're measuring
1
Change in Gastroparesis Cardinal Symptom Index Daily Dairy
Timeframe: Five weeks
2
Change in Patient Assessment of Upper Gastrointestinal Disorder Symptoms