Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain

Study Overview
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Brief Summary
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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.

Official Title
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Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain

Conditions
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Cystic Fibrosis, Irritable Bowel Syndrome, Chronic Pain

Intervention / Treatment
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* Device: Use of neurostimulation device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient open label intervention arm<br> | Device: Use of neurostimulation device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether PENFS therapy improves abdominal pain and IBS-symptom severity in CF. | Investigators hypothesize that at 8 weeks following PENFS treatment initiation, the average abdominal pain score will be reduced by 30% as compared to baseline. | 1-8 weeks | 
| : To assess the CFQ-R and PedsQL Gastrointestinal Scale Score in response to IB-Stim treatment. | Investigators hypothesize . At 4 and 8 weeks following PENFS treatment initiation, the CFQ-R and PedsDL will improve compared to baseline. | 1-4 weeks and 4-8 weeks | 
| To characterize the reduction in stool calprotectin inflammatory markers in response to IB-Stim | Investigators hypothesize that at 4 weeks following PENFS treatment initiation, there will be a reduction in stool calprotectin to baseline. | 1-4 weeks |