Percutaneous Electrical Nerve Field Stimulation for Gastroparesis

(PENFS Trial)

Overseen By

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Narcotic analgesics, Marinol

Disqualifiers: Pregnancy, Cardiac arrhythmia, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a device that sends mild electrical impulses to the area around the ear can help manage gastroparesis. Gastroparesis is a condition where the stomach doesn't empty properly, causing nausea and vomiting. The trial includes two groups: one receives the real device that sends electrical impulses, and the other receives a device that looks and feels the same but doesn't send impulses. This trial suits individuals who have had gastroparesis and diabetes for over a year, along with ongoing symptoms like nausea and vomiting. As an unphased trial, it offers the opportunity to contribute to innovative research that could improve gastroparesis management.

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.

What prior data suggests that this technique is safe for stimulating the vagus nerve?

Research shows that Percutaneous Electrical Nerve Field Stimulation (PENFS) is generally well-tolerated. Studies have found no serious side effects associated with its use. Other research has noted improvements in symptoms such as stomach pain and nausea within weeks of starting treatment. However, some evidence indicates that more information is needed to fully understand its safety and effectiveness. Overall, available data suggests that PENFS is safe, with no major safety concerns reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about percutaneous electrical nerve field stimulation (PENFS) for gastroparesis because it offers a non-drug alternative that targets the nervous system directly. Unlike traditional treatments that rely on medications to manage symptoms, PENFS uses low-frequency electrical impulses delivered through a device placed behind the ear to stimulate nerves in the auricle. This innovative approach could potentially reduce symptoms by enhancing nerve function without the side effects associated with medications. Additionally, it provides hope for patients who haven't seen improvements with existing treatments.

What evidence suggests that percutaneous electrical nerve field stimulation is effective for gastroparesis?

Research has shown that Percutaneous Electrical Nerve Field Stimulation (PENFS) might help people with gastroparesis, a condition where the stomach struggles to empty. In this trial, participants will join one of two groups: one receiving active PENFS, which transmits low-frequency electrical impulses, and another receiving a sham version with no electrical charge. Earlier studies demonstrated that patients experienced better control over symptoms like nausea and stomach pain. Specifically, one study found that 19 patients could stop using nutritional support due to improvement. Another study reported significant nausea reduction and a trend toward less stomach pain. Overall, these findings suggest that PENFS could effectively manage gastroparesis symptoms. ^{1 2 5 6 7}

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

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)

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

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.

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?

Group I: ACTIVE (electrical charge) Active Control 1 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 Group 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06783504

Effect Of Percutaneous Electrical Nerve Field Stimulation ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10869640/

Percutaneous Electrical Nerve Field Stimulation (PENFS) in ... Improvements in abdominal pain, nausea, and functional disability were sustained at 6-12 months and benefits in anxiety and catastrophizing ...

3. withpower.com withpower.com/trial/percutaneous-electrical-nerve-field-stimulation-for-gastroparesis-d0325

Percutaneous Electrical Nerve Field Stimulation for ... The procedure significantly improved patients' symptoms, allowed 19 previously dependent patients to discontinue nutritional support, and led to a notable ...

4. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2022.909149/full

Gastric Electrical Stimulation: Role and Clinical Impact on ... Vomiting frequency was reduced in 30.6% of patients during the ON period compared to only 16.5% of patients during the OFF period in the ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715923007079

Percutaneous Electrical Nerve Field Stimulation in ... Subjective responses showed nausea improvement (p = 0.01) and a trend for improvement in abdominal pain (p = 0.07) at week three. Abdominal pain subjectively ...

6. molinahealthcare.com molinahealthcare.com/-/media/Molina/PublicWebsite/PDF/Providers/wa/Medicaid/resource/mcp-mcr/MCP-383-IB-Stim-Device-for-Abdominal-Pain-in-Adolescents.pdf

Percutaneous Electrical Nerve Field Stimulator (P E N F S) ... There is insufficient published evidence to assess the safety and efficacy of the IB-Stim device on health outcomes or management of patients ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jpn3.12118

Percutaneous electrical nerve field stimulation for ... Efficacy, adherence, and safety were modeled on clinical trial data, noting that no serious adverse events occurred with the use of PENFS.