Percutaneous Electrical Nerve Field Stimulation for Gastroparesis
(PENFS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byThomas V Nowak, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Indiana University

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with Type 1 or Type 2 diabetes who are experiencing stomach issues like nausea and vomiting due to gastroparesis. Participants should be interested in a non-drug treatment involving nerve stimulation.

Inclusion Criteria

I have nausea and vomiting due to slow stomach emptying, not from other causes.

Willing to have one teaspoon (5 ml) of blood drawn

Documented Hb A1c within three months of screening or at the time of screening (<=8.0)

+5 more

Exclusion Criteria

I have had surgery to remove part of my vagus nerve.

Those having a cardiac pacemaker will be excluded from the study

I do not have hemophilia or psoriasis vulgaris.

+14 more

Participant Groups

The study is testing if stimulating the vagus nerve through the skin near the ear can help control symptoms of gastroparesis in diabetic patients. This method uses electrical pulses to potentially improve stomach function.

2Treatment groups

Active Control

Placebo Group

Group I: ACTIVE (electrical charge)Active Control1 Intervention

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.

Group II: Sham percutaneous electrical nerve field stimulation (no electrical charge)Placebo Group1 Intervention

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.