Electrical Nerve Field Stimulation for Irritable Bowel Syndrome

Recruiting in Palo Alto (17 mi)

Overseen byLin Chang, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Los Angeles

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a prospective, double-blind, randomized, sham-controlled pilot study evaluating the efficacy of percutaneous electrical nerve field stimulation for the treatment of adult patients with irritable bowel syndrome (IBS).

Eligibility Criteria

Adults aged 18-60 with IBS, experiencing significant abdominal pain and meeting specific criteria for symptom severity can join this trial. They must have stable medication doses if applicable and not have other conditions causing abdominal pain or certain surgeries. Pregnant individuals, those on opioids or with neurological issues are excluded.

Inclusion Criteria

I am between 18 and 60 years old and can sign a consent form.

My IBS symptoms are at least moderate in severity.

I experience abdominal pain at least 2 days every week.

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Exclusion Criteria

You have hemophilia or other conditions that make you bleed easily.

I use opioids or benzodiazepines regularly, or I use illegal drugs.

I have a history of neurological conditions like seizures or MS.

See 11 more

Treatment Details

Interventions

Percutaneous Electrical Nerve Field Stimulation (Peripheral Nerve Stimulation)
Sham Device (Behavioural Intervention)

Trial OverviewThe study is testing a device called PENFS that stimulates nerves to see if it helps adults with IBS. Participants will be randomly assigned to get either the real PENFS device or a sham (fake) device without knowing which one they receive.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Peripheral Electrical Nerve Field Stimulation (PENFS) DeviceActive Control1 Intervention

The PENFS device has a battery activated generator and wire harness. Four leads are attached to the generator, each with a sterile 2 mm, titanium needle. The patient's ear is trans-illuminated to identify neurovascular bundles that are avoided during needle placement. The generator is attached with adhesive to the skin behind the patient's ear. Needles are inserted into the dorsal and ventral aspects of the ear, within 1-1.5 mm of the vascular branches to create a field effect. The device settings are standardized and deliver 3.2 volts with alternating frequencies (1 ms pulses of 1 Hz and 10 Hz) every 2 s. This stimulation targets central pain pathways through branches of cranial nerves V, VII, IX, and X, which innervate the external ear. The device is worn for 5 days/week for a total of 4 weeks. Patients remove devices at home on day 6 of each treatment cycle. Patients will be asked to wear a SmartWatch during the study to monitor heart rate.

Group II: Sham DevicePlacebo Group1 Intervention

The sham devices will be identical to the active devices but will not administer electrical charges. Per manufacturer design and patient anecdotal experience from previous studies, both active stimulation and sham are below detectable sensation threshold. Per report from previous studies, some patients may experience a sensation around the ear after percutaneous needle placement; however, this sensation can occur with equal likelihood in the active or sham device. The device is worn for 5 days a week for a total of 4 weeks. Patients remove devices at home on day 6 of each treatment cycle. Patients will also be asked to wear a SmartWatch as above.