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Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain

Primary Purpose

Cystic Fibrosis, Irritable Bowel Syndrome, Chronic Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of neurostimulation device
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Saint Louis University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient open label intervention arm

Arm Description

Outcomes

Primary Outcome Measures

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.
: 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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2022
Last Updated
July 25, 2023
Sponsor
St. Louis University
Collaborators
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05515250
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
Collaborators
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Irritable Bowel Syndrome, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient open label intervention arm
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Use of neurostimulation device
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine whether PENFS therapy improves abdominal pain and IBS-symptom severity in CF.
Description
Investigators hypothesize that at 8 weeks following PENFS treatment initiation, the average abdominal pain score will be reduced by 30% as compared to baseline.
Time Frame
1-8 weeks
Title
: To assess the CFQ-R and PedsQL Gastrointestinal Scale Score in response to IB-Stim treatment.
Description
Investigators hypothesize . At 4 and 8 weeks following PENFS treatment initiation, the CFQ-R and PedsDL will improve compared to baseline.
Time Frame
1-4 weeks and 4-8 weeks
Title
To characterize the reduction in stool calprotectin inflammatory markers in response to IB-Stim
Description
Investigators hypothesize that at 4 weeks following PENFS treatment initiation, there will be a reduction in stool calprotectin to baseline.
Time Frame
1-4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Unsure about the number of participants and their willingness to allow us to share the data.

Learn more about this trial

Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain

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