Percutaneous Electrical Nerve Field Stimulation for Gastroparesis
(PENFS Trial)
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking narcotic pain medications daily or are dependent on drugs like Marinol, you would not be eligible to participate.
Is percutaneous electrical nerve field stimulation generally safe for humans?
Research on gastric electrical stimulation, which is similar to percutaneous electrical nerve field stimulation, shows it is generally considered safe, but there can be complications like electrode erosion. These studies focus on its use for gastroparesis, and safety data from these can provide some reassurance about its general safety in humans.12345
How does Percutaneous Electrical Nerve Field Stimulation differ from other treatments for gastroparesis?
Percutaneous Electrical Nerve Field Stimulation is unique because it involves non-invasive electrical stimulation applied through the skin, unlike gastric electrical stimulation which requires surgical implantation. This method may offer a less invasive alternative for managing symptoms of gastroparesis.35678
What data supports the effectiveness of the treatment Percutaneous Electrical Nerve Field Stimulation for Gastroparesis?
Research on similar treatments, like gastric electrical stimulation, shows it can help people with gastroparesis (a condition where the stomach can't empty food properly) who don't respond to other treatments. This suggests that electrical stimulation methods might be effective for managing gastroparesis symptoms.235910
Who Is on the Research Team?
Thomas V Nowak, MD
Principal Investigator
IU School of Medicine/IU Health
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Percutaneous Electrical Nerve Field Stimulation (PENFS) treatment with or without stimulation over 5 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Percutaneous Electrical Nerve Field Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor