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Percutaneous Electrical Nerve Field Stimulation for Diabetes and Gastroparesis

This study is looking at how Percutaneous Electrical Nerve Field Stimulation (PENFS) affects symptoms and nervous system activity in people with Type 1 or Type 2 diabetes and gastroparesis (a condition where your stomach empties too slowly). Researchers want to see if stimulating the vagus nerve (a nerve that controls many body functions, including stomach function) with the IB-Stim device, which is placed near the ear, can help with nausea, vomiting, and stomach problems. The study will compare the IB-Stim device to a sham device (no electrical charge). To join, you must be 18-60 years old, have had gastroparesis for at least 12 months, and have documented delayed stomach emptying. The study will measure changes in gastroparesis symptoms after five weeks. The current recruitment status is unclear.

Study design
This is an interventional study where participants will be randomly assigned to receive either the active PENFS device or a sham device. The study plans to enroll 60 participants.
What's involved
You would have 6 study visits. Procedures include removing and replacing the PENFS device, completing questionnaires, having an ECG, galvanic skin response (GSR) assessment, a pneumatic belt to assess breathing, a physical exam, and blood draws.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at five weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06783504

Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2

Not Yet Recruiting
NAAges 18–60InterventionalTreatment
Indiana University
~60 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATIONSham percutaneous electrical nerve field stimulation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Gastroparesis Cardinal Symptom Index Daily Dairy
Measured over Five weeks
+1 more outcome measured

Conditions

Diabetes
Gastroparesis

Explore related trials

Diabetes MellitusGastroparesis

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Thomas V Nowak, MD · PRINCIPAL_INVESTIGATOR · IU School of Medicine/IU Health

Who to contact

Maureen Schilling, BS
[email protected]
317-278-2064
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 with hemophilia, psoriasis vulgaris are excluded
Those having a cardiac pacemaker will be excluded from the study.

What this trial measures

  • Change in Gastroparesis Cardinal Symptom Index Daily DairyFive weeks

    ANMS GASTROPARESIS CARDINAL SYMPTOM INDEX - DAILY DIARY this tool uses a list of 7 criteria for rating gastric symptoms. The scale ratings are: None, Mild, Moderate, Severe, and Very Severe.

  • Change in Patient Assessment of Upper Gastrointestinal Disorder SymptomsFive weeks

    Scores are calculated by averaging the scores for each item in the subscale, with scores ranging from 0 (none or absent) to 5 (very severe). Optimal outcome would be a score of zero, no episodes/symptoms.