Recruiting

Abdominal FES

Sponsor:

Craig Hospital

Code:

NCT06345781

Conditions

Spinal Cord Injuries

Neurogenic Bowel

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Abdominal Functional Electrical Stimulation

Study Details

Brief 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.

Conditions

Spinal Cord Injuries

Neurogenic Bowel

Study ID

NCT06345781

Start date

Apr 30, 2025

Status verified date

Mar, 2026

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Abdominal Functional Electrical Stimulation

All participants enrolled will receive the intervention.

Interventions

Abdominal Functional Electrical Stimulation

Functional electrical stimulation electrodes will be applied to the abdomen during a bowel program to assess effects of stimulation on bowel management time.

Primary outcome measure

  • Bowel Management Time (BMT) [ Time Frame: Daily (Weeks 1-10) ]

Central Contacts and Locations

Locations

Craig Hospital

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Principal Investigator:

Candy Tefertiller

More Information

Sponsor

Craig Hospital

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • Spinal Cord Injury
  • Functional Electrical Stimulation (FES)
  • Neurogenic Bowel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Craig Hospital on 2026-03-31.