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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
If receiving pharmacologic therapy for abdominal pain associated with IBS, doses must be stable for at least 60 days prior to enrollment in the trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, week 8
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 medication for IBS-related abdominal pain has been the same for the last 60 days.
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My IBS symptoms are at least moderate in severity.
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My IBS medication, which doesn't affect pain, has been the same for over 30 days.
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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.
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My worst daily stomach pain scores between 4 and 8 out of 10.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in average daily stool consistency from baseline
Abdominal Pain
Change in average weekly bloating symptoms from baseline
+8 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.

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Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,525 Previous Clinical Trials
10,279,780 Total Patients Enrolled
3 Trials studying Abdominal Pain
308 Patients Enrolled for Abdominal Pain
Innovative Health SolutionsIndustry Sponsor
3 Previous Clinical Trials
154 Total Patients Enrolled
Lin Chang, MDPrincipal Investigator - University of California, Los Angeles
Regents of the University of CA Emer Med, Resnick Neuropsychiatric Hospital at UCLA
University Of California (Medical School)
La Co Harbor Ucla Medical Center (Residency)
4 Previous Clinical Trials
116 Total Patients Enrolled

Media Library

Percutaneous Electrical Nerve Field Stimulation (Peripheral Nerve Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04428619 — N/A
Abdominal Pain Research Study Groups: Sham Device, Peripheral Electrical Nerve Field Stimulation (PENFS) Device
Abdominal Pain Clinical Trial 2023: Percutaneous Electrical Nerve Field Stimulation Highlights & Side Effects. Trial Name: NCT04428619 — N/A
Percutaneous Electrical Nerve Field Stimulation (Peripheral Nerve Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04428619 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being sought for this experiment?

"Yes, this clinical trial is still looking for patients. The original posting was on August 1st 2020 and there have since been 26th January 2021."

Answered by AI

Who would be an ideal candidate for this medical experiment?

"This study is enrolling 54 patients with irritable bowel syndrome between the ages of 18 and 60. Most importantly, candidates should meet the following criteria: If receiving pharmacologic therapy for IBS that does not have an effect on abdominal pain, doses must be stable for at least 30 days prior to enrollment in the trial., Minimum of 2 days of abdominal pain/week prior to starting trial., Patients must meet Rome IV criteria for IBS, confirmed by a gastroenterologist who specializes in functional GI disorders. Any of the IBS bowel habit subtypes (diarrhea, constipation, mixed bowel habits, unclassified) will"

Answered by AI

How many individuals are participating in this research?

"Yes, the information on clinicaltrials.gov indicates that this clinical trial is actively recruiting candidates. The study was first posted on 8/1/2020 and was most recently updated on 1/26/2021. The clinical trial is admitting 54 patients across 1 locations"

Answered by AI

Does this research opportunity have an age limit?

"This trial allows for a relatively large age range of potential participants from 18-60. However, there are 398 other trials more focused on children and 1073 studies with an elderly focus."

Answered by AI

Who else is applying?

What site did they apply to?
UCLA
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I’ve been diagnosed since I was 13. Originally, I was told to manage my symptoms by reducing stress and eating more fiber. However, my symptoms seem to increase after eating bread, pastas, and other things with gluten. I now swing from extreme constipation to diarrhea or soft airy stools. I tested negative for parasites in 2023 and my doctor prescribed two medication’s. That were not helpful.
PatientReceived no prior treatments
~1 spots leftby May 2024