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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство Sham percutaneous electrical nerve field stimulation
  SHAM (no electrical charge)

Первичные конечные точки

• Change in Gastroparesis Cardinal Symptom Index Daily Dairy [Срок оценки: Five weeks]
• Change in Patient Assessment of Upper Gastrointestinal Disorder Symptoms [Срок оценки: Five weeks]

Вторичные конечные точки (3)

• Change in Heart Rate Variability [Срок оценки: Five weeks.]
• Change in Anxiety [Срок оценки: Five weeks]
• Change in the measure of depression [Срок оценки: Five weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Indiana University Hospital — Indianapolis

Публикации

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

Идентификаторы

NCT: NCT06783504 · 18260

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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