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

Craig Hospital1 site in 1 country15 target enrollmentApril 30, 2025

ConditionsSpinal Cord Injuries Neurogenic Bowel

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Cord Injuries
Sponsor: Craig Hospital
Enrollment: 15
Locations: 1
Primary Endpoint: Bowel Management Time (BMT)
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 30, 2025

End Date

December 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Craig Hospital

Responsible Party

Principal Investigator

Candace Tefertiller

Executive Director of Research and Evaluation

Craig Hospital

Eligibility Criteria

Inclusion Criteria

•Chronic SCI (\> 12 months since injury) above the level of T11
•\> 18 years of age
•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.
•Portable smart device with video capabilities and internet access
•Willingness to access and/or download Zoom (videoconferencing software)

Exclusion Criteria

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

Outcomes

Primary Outcomes

Bowel Management Time (BMT)

Time Frame: Daily (Weeks 1-10)

This is measured by recording start and end time of bowel management session in study diary.

Secondary Outcomes

EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire(Week 1, Week 3, Week 7, Week 10)
International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire(Week 1, Week 3, Week 7, Week 10)
Intervention Acceptability(Week 7)
Bowel Management Strategy(Daily (Weeks 1-10))
Visual Analog Scale (VAS)(Week 1, Week 3, Week 7, Week 10)
Intervention Safety(Daily (Weeks 0-10))
Neurogenic Bladder Symptom Score (NBSS)(Week 1, Week 3, Week 7, Week 10)
Stimulation Dose(During active stimulation period (Weeks 3-7))