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Peripheral Nerve Stimulation

Electrical Nerve Field Stimulation for Irritable Bowel Syndrome

N/A

Recruiting

Led By Lin Chang, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults, aged 18-60 years, who are able to provide written, informed consent

At least moderate IBS symptom severity with an IBS-SSS of at least 175 (total score range 0-500)

Must not have

Patients on chronic opioids, benzodiazepines, or with illicit substance use

Patients under the age of 18 years or over the age of 60 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4, week 8

Summary

This trial will test whether a new treatment, percutaneous electrical nerve field stimulation, is effective for IBS.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects of the PENFS treatment may include discomfort at the site of stimulation, skin irritation, headache, or dizziness. Since some participants will receive a sham device, they might experience no actual side effects from the intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My IBS symptoms are at least moderate in severity.

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I experience abdominal pain at least 2 days every week.

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I have been diagnosed with IBS by a specialist according to Rome IV criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am either younger than 18 or older than 60.

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

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I have a condition that affects my movement.

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I have had surgery on my facial or throat nerves.

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I have skin conditions or injuries near my ear that could affect treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change in IBS symptom severity from baseline

Secondary study objectives

Change in average daily stool consistency from baseline

Abdominal Pain

Change in average weekly bloating symptoms from baseline

+7 more

Trial Design

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.

0 / 10Eligibility criteria met