RecruitingNot Applicable

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

United States15 participantsStarted 2025-04-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
✓. 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)

What they're measuring

Bowel Management Time (BMT)

Timeframe: Daily (Weeks 1-10)

Trial details

NCT IDNCT06345781

SponsorCraig Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Candy Tefertiller

303-789-8000 ctefertiller@craighospital.org

View on ClinicalTrials.gov More Spinal Cord Injuries trials