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NCT Number: NCT06783504

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Gastroparesis Glucose Metabolism Disorders Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION

Device

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 percutaneous electrical nerve field stimulation

Device

SHAM (no electrical charge)

Other names: Sham arm

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in Heart Rate Variability

    Time frame: Five weeks.

    Heart Rate Variability is reported on a 0-100 scale.

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lainna Cohen, MSW

CONTACT

[email protected]

3172780621

Maureen Schilling, BS

CONTACT

[email protected]

317-278-2064

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Effect Of Percutaneous Electrical Nerve Field Stimulation (PENFS) On Symptom Control And Autonomic Nervous System Activity In Patients With Diabetes Mellitus

Acronym: PENFS

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Jan 20, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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