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

Not Applicable

Not yet recruiting

• Conditions: Diabetes; Gastroparesis

• Registration Number: NCT06783504
• Lead Sponsor: Indiana University

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.

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 Timeline

• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Study Start: 2026-02-10
• Primary Completion: 2027-02
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Gastroparesis Cardinal Symptom Index Daily Dairy	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.
Change in Patient Assessment of Upper Gastrointestinal Disorder Symptoms	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 Outcome Measures

Name	Time	Method
Change in Heart Rate Variability	Five weeks.	Heart Rate Variability is reported on a 0-100 scale.
Change in Anxiety	Five weeks	The General Anxiety Disorder (GAD)-7 scale is from 0-21, where 0= no anxiety and 21=severe anxiety
Change in the measure of depression	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.

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States