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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits
  • Time periods mentioned: 5 days
  • Procedures mentioned: Heart tracing (ECG), Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Eligible participants will then return for 5 Study Visits at which, they will: * Complete will complete 4 questionnaires * Lie in a supine position and have ECG electrodes applied to the chest and/or arms, palmar skin electrodes placed on the fingers of the non-dominant hand to measure galvanic skin response (GSR) and sympathetic nerve activity, and a chest strap to record respiratory activity."
  • "Once the equipment is placed, electrocardiogram (ECG) and GSR will be recorded for 20 minutes in the supine position."
  • "After the 20 minutes, participants will be asked to sit while ECG and GSR are recorded for 2 additional minutes."
  • "The device will remain in place for 5 days after each visit."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether electrical stimulation of the vagus nerve through the outer ear can help reduce nausea and vomiting. It is for people with type 1 or type 2 diabetes and gastroparesis, a condition that makes the stomach empty too slowly.

The purpose of this study is to evaluate whether stimulation of the vagus nerve can improve nausea and vomiting in diabetic gastroparetic patients.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Willing to have one teaspoon of blood drawn.
  • Willing to have electrodes, which deliver electrical signals, placed in the outer ear.
  • Have had a diagnosis of gastroparesis for at least 12 months.
  • Have type 1 or type 2 diabetes.
  • Had a standard scrambled-egg stomach scan in the past 2 years showing that more than 10% of the meal stayed in the stomach after 4 hours.
  • Had an upper digestive tract camera test in the past 5 years showing no physical blockage.
  • Have nausea and vomiting caused by gastroparesis, not another condition.
  • Have an HbA1c result of 8.0 or less from the past 3 months or at screening. This blood test measures average blood sugar.

Who can't join

  • Cannot give consent, or are pregnant.
  • Have intestinal pseudo-obstruction, where the bowel acts blocked without a physical blockage; a swallowing disorder; or vomiting caused by mental or emotional factors rather than gastroparesis.
  • Have an abnormal heartbeat or a heart pacemaker.
  • Have had stomach surgery, surgery to cut the vagus nerve, or an organ transplant.
  • Have a history of seizures, hemophilia (a bleeding disorder), or psoriasis vulgaris (a skin condition).
  • Depend on drugs such as Marinol for the condition, or take opioid pain medicines daily.
  • Have an unstable medical condition or a high risk of problems from surgery.
  • Have poorly controlled diabetes, with an HbA1c above 8 in the past 3 months or at screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Wiling to have one teaspoon (5 ml) of blood drawn. * Willing to have electrodes placed in the external ear. * 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 sites (1)

IN