Early access
Sign in
Not yet taking people in United StatesNo phase

Tests nerve stimulation for nausea and vomiting in people with diabetes

Tests electrical nerve stimulation against a sham device in adults with diabetic gastroparesis.

Key facts

Who runs it
Indiana University
Where
Indianapolis, United StatesSee the site
Trial code
Registry title
Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2
Status
Not yet recruiting
People taking part
60 people, planned
Starts
10 Feb 2027
Expected to end
Feb 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION
  • Sham percutaneous electrical nerve field stimulation
Record updated
1 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 60 with type 1 or type 2 diabetes and gastroparesis. It tests whether stimulating nerves in the ear eases nausea and vomiting.

Age
18 Years to 60 Years
Sex
All sexes
Disease stage
Gastroparesis for 12 months or longer, with delayed stomach emptying shown on a scrambled-egg scan in the last two years. Upper GI endoscopy in the last five years must show no blockage. Nausea and vomiting must fit gastroparesis.
Biomarker or test result
Hb A1c of 8.0 or lower, documented within three months of screening or at screening.

Main reasons for not taking part

  • Pregnant women
  • Heart rhythm problem or a cardiac pacemaker
  • Earlier stomach surgery, vagotomy or organ transplant
  • Poorly controlled diabetes (Hgb A1c above 8)
  • Daily use of narcotic pain medicine

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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

Check if you might fit

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?

Where in United States

  • Indiana University HospitalIndianapolis, United StatesContact: Maureen Schilling, BSNot yet recruiting

About the trial

What the trial wants to find out

The purpose of this study is to evaluate whether stimulation of the vagus nerve can improve nausea and vomiting in diabetic gastroparetic patients.

The 2 groups in the trial

  • ACTIVE (electrical charge)Existing treatment, for comparison

    The PENFS device is placed behind the patient's left ear and connected to stimulation needles on the auricle. The appliance transmits low-frequency electrical impulses throughout the auricle.

    Treatment: PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION

  • Sham percutaneous electrical nerve field stimulation (no electrical charge)Sham treatment, for comparison

    The PENFS device is placed behind the patient's left ear and connected to stimulation needles on the auricle. The appliance will not transmit any electrical impulses.

    Treatment: Sham percutaneous electrical nerve field stimulation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effect Of Percutaneous Electrical Nerve Field Stimulation (PENFS) On Symptom Control And Autonomic Nervous System Activity In Patients With Diabetes Mellitus
Plain-language title
Tests nerve stimulation for nausea and vomiting in people with diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06783504, who can take part
Record updated
1 October 2026