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NCT06345781NARecruiting

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

Craig Hospital

Start Date

4/30/2025

Completion Date

5/1/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

Abdominal Functional Electrical Stimulation

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Conditions

Spinal Cord InjuriesNeurogenic Bowel

Locations

Craig Hospital

Englewood, Colorado 80113

United States