Clinical trial NCT05515250: Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain
Official title: Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cystic Fibrosis
Irritable Bowel Syndrome
Chronic Pain
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2022-08-25
Enrollment: 1
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 electromagnetic device
* Inability to comply with study protocol and follow up, per study doctor's judgement.
* Pregnant females, females who are breastfeeding or who believe they may wish to become pregnant during the course of the study
* Males and females of reproductive potential who are unwilling to use effective measures (chosen in consultation with their health care provider) to avoid becoming pregnant.

Primary outcomes:
measure: IBS Severity Scoring System-Change Between Baseline and Week 8 is Reported.
timeFrame: baseline and 8 weeks
measure: CFQ-R and PedsQL Gastrointestinal Scale Score in Response to IB-Stim Treatment- Baseline and Week 8 Reported
timeFrame: baseline and 8 weeks
measure: Reduction in Stool Calprotectin Inflammatory Markers in Response to IB-Stim-change Between Two Time Point is Reported.
timeFrame: Baseline and week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
References:
citation: Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.