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

April 28, 2026 updated by: Thomas V. Nowak, Indiana University

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 find out if we can stimulate the vagus nerve. The vagus nerve is a largely internal nerve that controls many bodily functions, including stomach function. We hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Each participant will be randomized to receive Percutaneous Electrical Nerve Field Stimulation (PENFS) treatment with or without stimulation. The study involves 6 study visits. Study procedures include: removing and replacing the PENFS device, questionnaires, ECG, assessment use of galvanic skin response (GSR), pneumatic belt to assess breathing, physical examine, and blood draws.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Maureen Schilling, BS
  • Phone Number: 317-278-2064
  • Email: maschi@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital
        • Principal Investigator:
          • Thomas V Nowak, MD
        • Contact:
        • Contact:
          • Maureen Schilling, BS
          • Phone Number: 317-278-2064
          • Email: maschi@iu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ACTIVE (electrical charge)
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.
Device: PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION
The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week up to 3 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS.
Other Names:
  • IB-STIM
Sham Comparator: Sham percutaneous electrical nerve field stimulation (no electrical charge)
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.
Device: Sham percutaneous electrical nerve field stimulation
SHAM (no electrical charge)
Other Names:
  • Sham arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gastroparesis Cardinal Symptom Index Daily Dairy
Time Frame: Five 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.
Five weeks
Change in Patient Assessment of Upper Gastrointestinal Disorder Symptoms
Time Frame: Five 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.
Five weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate Variability
Time Frame: Five weeks.
Heart Rate Variability is reported on a 0-100 scale.
Five weeks.
Change in Anxiety
Time Frame: Five weeks
The General Anxiety Disorder (GAD)-7 scale is from 0-21, where 0= no anxiety and 21=severe anxiety
Five weeks
Change in the measure of depression
Time Frame: Five weeks
Patient Health Questionnaire (PHQ)-8 is a questionnaire that measures self-reported depressive systems. PHQ-8 uses a range from 0-24, where 0=no depressive symptoms and 24=severe symptoms.
Five weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Thomas V Nowak, MD, IU School of Medicine/IU Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 10, 2027

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18260

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data and devices will be stored containing only the study subject number and dates of device usage. Sharing this data will not involve any IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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