Tests nerve stimulation for nausea and vomiting in people with diabetes
Tests electrical nerve stimulation against a sham device in adults with diabetic gastroparesis.
Plain-language title generated from the registry record
Registry title: Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2
Key facts
- Where
- Indianapolis, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT06783504, who can take part
Where in United States
- Indiana University HospitalIndianapolis, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Indiana University
- Trial code
- NCT06783504
- Record updated
- 1 October 2026
- Original description
The purpose of this study is to evaluate whether stimulation of the vagus nerve can improve nausea and vomiting in diabetic gastroparetic patients.Read full original descriptionShow less
Effect Of Percutaneous Electrical Nerve Field Stimulation (PENFS) On Symptom Control And Autonomic Nervous System Activity In Patients With Diabetes Mellitus
The purpose of this study is to evaluate whether stimulation of the vagus nerve can improve nausea and vomiting in diabetic gastroparetic patients.
Inclusion: Wiling to have one teaspoon (5 ml) of blood drawn; Willing to have electrodes placed in the external ear; 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: History of prior gastric surgery; Those at high surgical risk; Diagnosed with cardiac arrhythmia; 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 with poorly controlled diabetes mellitus (Hgb A1c>8) within three months of screening or at the time of screening; Those having a cardiac pacemaker will be excluded from the study; Unable to provide consent; Pregnant females; Medical records indicate intestinal pseudo-obstruction; Those diagnosed with psychogenic vomiting and not related to gastroparesis; Medically unstable subjects; Subjects taking narcotic analgesics daily; Subjects diagnosed with hemophilia, psoriasis vulgaris are excluded.