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

Key facts

Where
Englewood, United StatesSee the site

Where in United States

  • Craig HospitalEnglewood, United StatesContact: Candy TefertillerTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Craig Hospital
Trial code
NCT06345781
Record updated
31 March 2026
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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).

Exclusion: Previous history of uncontrolled, recurrent episodes of AD; American Spinal Injuries Association (ASIA) Impairment Scale (AIS) E; 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); No response to AFES (e.g., lower motor neuron impairment); History of gastrointestinal surgery within the past 3 months; Self-reported bowel management time (BMT) of <30 minutes; Stoma or colostomy; Severely obese participants (>40 BMI); Primary language other than English; Resting systolic blood pressure (BP) reported as >140 mmHg.

ClinicalTrials.gov NCT06345781