NCT06783504Not yet recruiting
Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2
Effect Of Percutaneous Electrical Nerve Field Stimulation (PENFS) On Symptom Control And Autonomic Nervous System Activity In Patients With Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate whether stimulation of the vagus nerve can improve nausea and vomiting in diabetic gastroparetic patients.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 9 Sept 2024
- Start date
- 10 Feb 2027
- Primary completion date
- Feb 2029
- Lead sponsor
- Indiana University
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06783504
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 10 Feb 2027 to the primary completion date, Feb 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior gastric surgery
- Those at high surgical risk
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indiana University Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.