Abdominal electrical stimulation to improve bowel function after spinal cord injury.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses abdominal functional electrical stimulation (FES) applied during participants' regular bowel routines to see if stimulation shortens bowel management time. Adults with chronic (>12 months) spinal cord injury above T11 will use a portable stimulation device, with some sessions monitored or supported via video (Zoom). The primary outcome is change in bowel management time, and secondary outcomes include bowel-related quality of life, participant-reported bowel function, bowel management strategy, bladder symptoms, and unplanned hospital admissions. The study will also collect participants' perspectives and experiences with the stimulation sessions and device use.

Why it matters

Who can join: the full rules

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

Where it's running

• Craig Hospital
  Englewood, Colorado, United States Recruiting

Study contacts

• Study coordinator: Candy Tefertiller
• Email: ctefertiller@craighospital.org
• Phone: 303-789-8000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.