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Electrical Nerve Field Stimulation for Irritable Bowel Syndrome
Study Summary
This trial will test whether a new treatment, percutaneous electrical nerve field stimulation, is effective for IBS.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have hemophilia or other conditions that make you bleed easily.I am between 18 and 60 years old and can sign a consent form.My IBS symptoms are at least moderate in severity.I use opioids or benzodiazepines regularly, or I use illegal drugs.I have a history of neurological conditions like seizures or MS.I experience abdominal pain at least 2 days every week.I have had abdominal surgery, but it was not an appendectomy or cholecystectomy, and it was over 6 months ago.I have been diagnosed with IBS by a specialist according to Rome IV criteria.My worst daily stomach pain scores between 4 and 8 out of 10.I am unwilling to wear a SmartWatch on my wrist.I have IBS as my main condition, despite having other stomach or bowel issues.You have any implanted electronic device.My medication for IBS-related abdominal pain has been the same for the last 60 days.I am either younger than 18 or older than 60.My IBS medication, which doesn't affect pain, has been the same for over 30 days.You have mental health conditions.I have a condition that affects my movement.I have had surgery on my facial or throat nerves.I have skin conditions or injuries near my ear that could affect treatment.
- Group 1: Sham Device
- Group 2: Peripheral Electrical Nerve Field Stimulation (PENFS) Device
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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"
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"
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."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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