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

Launched by INDIANA UNIVERSITY · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people with diabetes who also have gastroparesis, a condition that affects how the stomach works and can cause symptoms like nausea and vomiting. Researchers want to see if stimulating the vagus nerve, which helps control many functions in the body, can improve these symptoms. They plan to do this by using a small electrical device placed around the ear to stimulate the nerve.

To participate in the trial, you need to be diagnosed with gastroparesis for at least a year and have either Type 1 or Type 2 diabetes. You should also have a recent test showing that your stomach is not emptying properly and be experiencing nausea and vomiting related to gastroparesis. If you join the study, you can expect to have a small amount of blood drawn and participate in sessions where the nerve is stimulated. This trial is currently not recruiting participants, but it aims to better understand how this treatment could help improve stomach function for those suffering from these conditions.

Gender

ALL

Eligibility criteria

• 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.