Abdominal electrical stimulation to improve bowel function after spinal cord injury.
Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury
We will test whether abdominal electrical stimulation can shorten how long adults with chronic spinal cord injury spend on bowel care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Craig Hospital Academic / other |
| Locations | 1 site (Englewood, Colorado) |
| Trial ID | NCT06345781 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with chronic spinal cord injury (>12 months) above T11 who have a consistent bowel routine with a measurable start and end and who can use a smart device and Zoom are ideal candidates.
Not a fit: People with normal bowel function (AIS E), active gastrointestinal conditions such as Crohn's disease or bowel obstruction, bowel management time under 30 minutes, or physical barriers preventing device use are unlikely to benefit.
Why it matters
Potential benefit: If successful, the intervention could shorten bowel care time and improve bowel-related quality of life for people with chronic spinal cord injury.
How similar studies have performed: Small pilot studies of abdominal or related functional electrical stimulation approaches have shown promising improvements in bowel function, but larger, high-quality trials remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Englewood, Colorado
- Craig Hospital — Englewood, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Candy Tefertiller
- Email: ctefertiller@craighospital.org
- Phone: 303-789-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.