Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain

NCT ID: NCT05515250

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-29
• Study Completion Date: 2023-07-25

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.

Conditions

Cystic Fibrosis; Irritable Bowel Syndrome; Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient open label intervention arm

Group Type: OTHER

Use of neurostimulation device

Intervention Type: DEVICE

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.

Interventions

Use of neurostimulation device

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Dhiren Patel, MD

MBBS, MD Associate Professor of Pediatrics, Medical Director of Neurogastroenterology and Motility

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Saint Louis University

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 9146781 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Main plan

View Document

Other Identifiers

31972

Identifier Type: -

Identifier Source: org_study_id