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

NCT06783504 | Not Yet Recruiting FDA Device

• 1 other identifier: 18260
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroparesis; Diabetes

Outcome Measures

Primary Outcomes (2)

• Change in Gastroparesis Cardinal Symptom Index Daily Dairy

  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

  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 Outcomes (3)

• Change in Heart Rate Variability

  Five weeks.

• Change in Anxiety

  Five weeks

• Change in the measure of depression

  Five weeks

Study Arms (2)

ACTIVE (electrical charge)

ACTIVE COMPARATOR

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

Sham percutaneous electrical nerve field stimulation (no electrical charge)

SHAM COMPARATOR

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

Interventions

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.

Also known as: IB-STIM

ACTIVE (electrical charge)

Sham percutaneous electrical nerve field stimulation DEVICE

SHAM (no electrical charge)

Also known as: Sham arm

Sham percutaneous electrical nerve field stimulation (no electrical charge)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (15)

• Revicki DA, Speck RM, Lavoie S, Puelles J, Kuo B, Camilleri M, Almansa C, Parkman HP. The American neurogastroenterology and motility society gastroparesis cardinal symptom index-daily diary (ANMS GCSI-DD): Psychometric evaluation in patients with idiopathic or diabetic gastroparesis. Neurogastroenterol Motil. 2019 Apr;31(4):e13553. doi: 10.1111/nmo.13553. Epub 2019 Feb 7.

  PMID: 30734412 BACKGROUND

• Kovacic K, Kolacz J, Lewis GF, Porges SW. Impaired Vagal Efficiency Predicts Auricular Neurostimulation Response in Adolescent Functional Abdominal Pain Disorders. Am J Gastroenterol. 2020 Sep;115(9):1534-1538. doi: 10.14309/ajg.0000000000000753.

  PMID: 32732620 BACKGROUND

• Berntson GG, Bigger JT Jr, Eckberg DL, Grossman P, Kaufmann PG, Malik M, Nagaraja HN, Porges SW, Saul JP, Stone PH, van der Molen MW. Heart rate variability: origins, methods, and interpretive caveats. Psychophysiology. 1997 Nov;34(6):623-48. doi: 10.1111/j.1469-8986.1997.tb02140.x.

  PMID: 9401419 BACKGROUND

• Lewis GF, Furman SA, McCool MF, Porges SW. Statistical strategies to quantify respiratory sinus arrhythmia: are commonly used metrics equivalent? Biol Psychol. 2012 Feb;89(2):349-64. doi: 10.1016/j.biopsycho.2011.11.009. Epub 2011 Dec 3.

  PMID: 22138367 BACKGROUND

• Porges SW. Method and apparatus for evaluating rhythmic oscillations in aperiodic physiological response systems. US4510944A, 1985 cited 2020 Aug 4.

  BACKGROUND

• Asahina M, Poudel A, Hirano S. Sweating on the palm and sole: physiological and clinical relevance. Clin Auton Res. 2015 Jun;25(3):153-9. doi: 10.1007/s10286-015-0282-1. Epub 2015 Apr 17.

  PMID: 25894655 BACKGROUND

• 11. Dawson ME, Schell AM, Filion DL. The electrodermal system. In: Handbook of Physiology. 3rd ed. New York: Cambridge University Press; 2007. p. 159-81.

  BACKGROUND

• Woodbury A, Krishnamurthy V, Gebre M, Napadow V, Bicknese C, Liu M, Lukemire J, Kalangara J, Cui X, Guo Y, Sniecinski R, Crosson B. Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial. Pain Med. 2021 Mar 18;22(3):715-726. doi: 10.1093/pm/pnaa317.

  PMID: 33164085 BACKGROUND

• Krasaelap A, Sood MR, Li BUK, Unteutsch R, Yan K, Nugent M, Simpson P, Kovacic K. Efficacy of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial. Clin Gastroenterol Hepatol. 2020 Aug;18(9):1987-1994.e2. doi: 10.1016/j.cgh.2019.10.012. Epub 2019 Oct 14.

  PMID: 31622740 BACKGROUND

• Santucci NR, King C, El-Chammas KI, Wongteerasut A, Damrongmanee A, Graham K, Fei L, Sahay R, Jones C, Cunningham NR, Coghill RC. Effect of percutaneous electrical nerve field stimulation on mechanosensitivity, sleep, and psychological comorbidities in adolescents with functional abdominal pain disorders. Neurogastroenterol Motil. 2022 Aug;34(8):e14358. doi: 10.1111/nmo.14358. Epub 2022 Mar 16.

  PMID: 35293081 BACKGROUND

• Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18.

  PMID: 28826627 BACKGROUND

• Ward MP, Gupta A, Wo JM, Rajwa B, Furness JB, Powley TL, Nowak TV. An emerging method to noninvasively measure and identify vagal response markers to enable bioelectronic control of gastroparesis symptoms with gastric electrical stimulation. J Neurosci Methods. 2020 Apr 15;336:108631. doi: 10.1016/j.jneumeth.2020.108631. Epub 2020 Feb 20.

  PMID: 32087238 BACKGROUND

• Frangos E, Ellrich J, Komisaruk BR. Non-invasive Access to the Vagus Nerve Central Projections via Electrical Stimulation of the External Ear: fMRI Evidence in Humans. Brain Stimul. 2015 May-Jun;8(3):624-36. doi: 10.1016/j.brs.2014.11.018. Epub 2014 Dec 6.

  PMID: 25573069 BACKGROUND

• Garcia RG, Lin RL, Lee J, Kim J, Barbieri R, Sclocco R, Wasan AD, Edwards RR, Rosen BR, Hadjikhani N, Napadow V. Modulation of brainstem activity and connectivity by respiratory-gated auricular vagal afferent nerve stimulation in migraine patients. Pain. 2017 Aug;158(8):1461-1472. doi: 10.1097/j.pain.0000000000000930.

  PMID: 28541256 BACKGROUND

• Abell T, McCallum R, Hocking M, Koch K, Abrahamsson H, Leblanc I, Lindberg G, Konturek J, Nowak T, Quigley EM, Tougas G, Starkebaum W. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. 2003 Aug;125(2):421-8. doi: 10.1016/s0016-5085(03)00878-3.

  PMID: 12891544 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Gastroparesis

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas V Nowak, MD

  IU School of Medicine/IU Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen Schilling, BS

CONTACT

317-278-2064; maschi@iu.edu

Lainna Cohen, MSW

CONTACT

3172780621; larcohen@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The Sham arm will have single blind masking. The participant will not know if they are in the Stimulation arm or the Sham arm; only the coordinator/tech will know the status of the arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Model Details: This is a double blind, randomized, sham controlled study. A total of 30 subjects will be enrolled at Indiana University and another 30 at Ohio State University) with 15 subjects in each arm (PENFS device or Sham (no electrical charge)).

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: January 20, 2025
• Study Start (Estimated): February 10, 2027
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)