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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Indiana University Hospital
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.