Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT05515250
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
18 Years
Study:
NCT05515250
Study Brief:
Protocol Section:
NCT05515250