Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain (NCT05515250) | Clinical Trial Compass
TerminatedNot Applicable
Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain
Stopped: inadequate enrollment. Found only one participant over 1 year as opposed to anticipated over 15 patients. Inadequate research funding and staff support also added to this decision.
United States1 participantsStarted 2023-03-29
Plain-language summary
Chronic abdominal pain is extremely common in individuals with Cystic Fibrosis (CF). Therapy for chronic abdominal pain is very limited and generally consists of osmotic laxatives or drugs that are used to treat irritable bowel syndrome (IBS), most of which are off-label and not proven to be effective for CF patients. Abdominal pain negatively impacts the quality of life (QOL). With the development of novel therapies for CF, life expectancy has significantly increased. There is, therefore, a critical need to identify treatment pathways for chronic abdominal pain in children with CF.
In humans, abdominal pain is modulated by the vagus nerve. Stimulation of the vagus nerve has been suggested to reduce visceral sensitivity and abdominal pain. IB-stim is the Percutaneous Electrical Nerve Field Stimulation (PENS) device. It is a non-invasive, outpatient therapy. PENFS has been shown to be efficacious in pediatric patients with abdominal pain. The FDA has cleared and classified this device as class II, suggesting minimal to moderate risk.
There is increasing evidence of intestinal inflammation in patients with CF, which could help explain the GI symptoms and differentiate from IBS. Studies have reported increased inflammation in the intestines using fecal calprotectin.
With the implementation of this study, investigators hypothesize that the IB -Stim device will reduce their overall GI inflammation and abdominal pain.
Who can participate
Age range
11 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* English-speaking and willing to consent and follow the study protocol
* Children with CF aged 11-17 years at the time of enrollment. All races, ethnic groups and both sexes will be included. Patient turning 18 years after enrollment in the study will continue in study and complete remaining study visits.
* Minimum of 2 days of abdominal pain/week for a duration of two months or greater prior to starting the study
* Average weekly abdominal pain score of at least 3 for the previous 2 weeks prior to entering the study (on a 0-10-point rating scale).
* Abdominal pain is not explained by any major organic etiology and comprehensive work up failed to identify any single cause for patients' symptoms
EXCLUSION CRITERIA:
* Patients age of 18 years and over, or less than 11 years at the time of enrollment
* Patients who cannot provide informed consent or do not speak English
* Patients with abdominal pain that can be explained clinically by other GI diagnoses other than CF per study doctor's judgement
* History of cranial nerve or major abdominal surgeries in last 6 months
* Patients with underlying neurologic conditions, including history of ongoing seizures or traumatic brain injury within last 6 months
* Patients with dermatologic conditions affecting the ears (i.e. psoriasis), or with cuts or abrasions to the external ear that would interfere with electrode placement
* Patients with hemophilia or other bleeding disorders
* Patients with any implanted elect…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
IBS Severity Scoring System-Change Between Baseline and Week 8 is Reported.
Timeframe: baseline and 8 weeks
2
CFQ-R and PedsQL Gastrointestinal Scale Score in Response to IB-Stim Treatment- Baseline and Week 8 Reported
Timeframe: baseline and 8 weeks
3
Reduction in Stool Calprotectin Inflammatory Markers in Response to IB-Stim-change Between Two Time Point is Reported.