60 Participants Needed

Percutaneous Electrical Nerve Field Stimulation for Gastroparesis

(PENFS Trial)

MS
Overseen By
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

TV

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

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)
See 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.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Percutaneous Electrical Nerve Field Stimulation (PENFS) treatment with or without stimulation over 5 weeks

5 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Percutaneous Electrical Nerve Field Stimulation
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: ACTIVE (electrical charge)Active Control1 Intervention
Group II: Sham percutaneous electrical nerve field stimulation (no electrical charge)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Published Research Related to This Trial

Gastric electrical stimulation was found to be a safe and effective alternative to gastrectomy for patients with refractory gastroparesis, showing no 30-day mortality and a median hospital stay of just 3 days.
The procedure significantly improved patients' symptoms, allowed 19 previously dependent patients to discontinue nutritional support, and led to a notable increase in body mass index and gastric emptying rates.
Gastric electrical stimulation: an alternative surgical therapy for patients with gastroparesis.Mason, RJ., Lipham, J., Eckerling, G., et al.[2022]
In a study of 55 patients with diabetic gastroparesis, gastric electrical stimulation (GES) using the Enterra system significantly reduced weekly vomiting frequency by 57% after 6 weeks and 67.8% after 1 year, indicating its efficacy in managing symptoms.
Patients also experienced improvements in overall symptom scores, gastric emptying, quality of life, and reduced hospital days, demonstrating the therapy's positive impact on both subjective and objective health measures.
Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study.McCallum, RW., Snape, W., Brody, F., et al.[2022]

Citations

Gastric electrical stimulation: an alternative surgical therapy for patients with gastroparesis. [2022]
Treatment of diabetic gastroparesis by high-frequency gastric electrical stimulation. [2022]
Gastric electrical stimulation: a novel treatment for gastroparesis. [2020]
Electrical stimulation for gastroparesis. Gastric motility restored. [2022]
Prospective evaluation of gastric neurostimulation for diabetic gastroparesis in Canada. [2019]
Adverse events of gastric electrical stimulators recorded in the Manufacturer and User Device Experience (MAUDE) Registry. [2022]
Erosion of gastric electrical stimulator electrodes: evaluation, management, and laparoscopic techniques. [2022]
Gastric electric stimulation for the treatment of gastroparesis. [2019]
Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Gastric Electric Stimulation for Refractory Gastroparesis. [2022]
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