RECRUITING

Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury

Conditions

Spinal Cord Injuries Neurogenic Bowel Spinal Cord Injury Functional Electrical Stimulation (FES)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to gather information about the effectiveness of abdominal FES to improve bowel management time (BMT) for people with chronic SCI. This study will also evaluate whether abdominal FES can improve: 1) bowel-related quality of life, 2) participant-reported bowel function, 3) bowel management strategy, 4) bladder symptoms, and 5) unplanned hospital admissions. In addition, we will also explore participant perspectives and experiences about the stimulation sessions and use of the device.

Official Title

Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury

Quick Facts

Study Start:2025-04-30

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06345781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Chronic SCI (\> 12 months since injury) above the level of T11 2. \> 18 years of age 3. a measurable and consistent start and end event is determinable for the bowel routine * Start events include: 1) enema insertion, 2) digital stimulation, 3) hot drink or initiation of the gastrocolic reflex, 3) abdominal massage, or 4) other, as determined by the participant and research team. * Ending events include: 1) final digital stimulation, 2) when evacuation has ceased, or 3) other, as determined by the participant and research team. 4. Portable smart device with video capabilities and internet access 5. Willingness to access and/or download Zoom (videoconferencing software)	1. American Spinal Injuries Association (ASIA) Impairment Scale (AIS) E 2. Self-reported bowel management time (BMT) of \<30 minutes 3. Current bowel conditions such as gastro-esophageal reflux, bowel obstruction, Crohn's disease, or diverticulitis 4. Physical obstacles that prevent AFES (e.g., pregnancy, abdominal trauma, cardiac pacemaker, or other implanted electromedical devices) 5. Stoma or colostomy 6. No response to AFES (e.g., lower motor neuron impairment) 7. History of gastrointestinal surgery within the past 3 months 8. Severely obese participants (\>40 BMI) 9. Primary language other than English 10. Previous history of uncontrolled, recurrent episodes of AD 11. Resting systolic blood pressure (BP) reported as \>140 mmHg

Inclusion Criteria

Exclusion Criteria

1. Chronic SCI (\> 12 months since injury) above the level of T11
2. \> 18 years of age
3. a measurable and consistent start and end event is determinable for the bowel routine
* Start events include: 1) enema insertion, 2) digital stimulation, 3) hot drink or initiation of the gastrocolic reflex, 3) abdominal massage, or 4) other, as determined by the participant and research team.
* Ending events include: 1) final digital stimulation, 2) when evacuation has ceased, or 3) other, as determined by the participant and research team.
4. Portable smart device with video capabilities and internet access
5. Willingness to access and/or download Zoom (videoconferencing software)

1. American Spinal Injuries Association (ASIA) Impairment Scale (AIS) E
2. Self-reported bowel management time (BMT) of \<30 minutes
3. Current bowel conditions such as gastro-esophageal reflux, bowel obstruction, Crohn's disease, or diverticulitis
4. Physical obstacles that prevent AFES (e.g., pregnancy, abdominal trauma, cardiac pacemaker, or other implanted electromedical devices)
5. Stoma or colostomy
6. No response to AFES (e.g., lower motor neuron impairment)
7. History of gastrointestinal surgery within the past 3 months
8. Severely obese participants (\>40 BMI)
9. Primary language other than English
10. Previous history of uncontrolled, recurrent episodes of AD
11. Resting systolic blood pressure (BP) reported as \>140 mmHg

Contacts and Locations

Study Contact

Candy Tefertiller

CONTACT

303-789-8000

ctefertiller@craighospital.org

Bria Mellick

CONTACT

303-789-8757

bmellick@craighospital.org

Study Locations (Sites)

Craig Hospital

Englewood, Colorado, 80113

United States

Collaborators and Investigators

Sponsor: Craig Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-30

Study Completion Date2025-12

Study Record Updates

Study Start Date2025-04-30

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Spinal Cord Injury
Functional Electrical Stimulation (FES)
Neurogenic Bowel

Additional Relevant MeSH Terms

Spinal Cord Injuries
Neurogenic Bowel