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

Recruiting now · Not applicable

Conditions studied: Spinal Cord Injuries, Neurogenic Bowel

In brief

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.

Key facts

Study ID

NCT06345781

Run by

Craig Hospital

People needed

15

Starts

2025-04-30

Expected to finish

2026-05-01

Last updated by the study team

2026-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• Resting systolic blood pressure (BP) reported as >140 mmHg

Where it is running

• Craig Hospital — Englewood, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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