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

Launched by CRAIG HOSPITAL · Mar 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a method called abdominal functional electrical stimulation (FES) to see if it can help people with spinal cord injuries (SCI) improve their bowel management. The main goal is to find out if this treatment can reduce the time it takes for participants to manage their bowel routines and enhance their overall quality of life related to bowel function. The study will also look at how this treatment affects bladder symptoms and whether it leads to fewer unplanned hospital visits. Participants will share their experiences with the stimulation sessions and using the device, which will help researchers understand its impact better.

To be eligible for this study, participants should be at least 18 years old, have had a spinal cord injury for over a year, and have a consistent bowel routine. They also need access to a portable smart device with video capabilities and the willingness to use a platform called Zoom for meetings. However, people with certain conditions, like severe obesity or specific bowel problems, won't be able to participate. This study is not yet recruiting, but it aims to gather important information that could improve bowel care for individuals with spinal cord injuries in the future.

Gender

ALL

Eligibility criteria

• Inclusion 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)
• Exclusion Criteria:
• • 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