Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06345781

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

Led by Craig Hospital · Updated on 2026-03-31

15

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

C

Craig Hospital

Lead Sponsor

N

Neuroscience Research Australia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a chronic spinal cord injury above the T11 level that occurred more than 12 months ago
  • Be older than 18 years of age
  • Have a measurable and consistent start and end event for the bowel routine, such as enema insertion, digital stimulation, hot drink initiation, abdominal massage, or other agreed events
  • Possess a portable smart device with video capabilities and internet access
  • Be willing to access and/or download Zoom videoconferencing software
Not Eligible

You will not qualify if you...

  • Have an American Spinal Injuries Association (ASIA) Impairment Scale (AIS) E classification
  • Self-report bowel management time less than 30 minutes
  • Have current bowel conditions like gastro-esophageal reflux, bowel obstruction, Crohn's disease, or diverticulitis
  • Have physical obstacles preventing abdominal FES, such as pregnancy, abdominal trauma, cardiac pacemaker, or other implanted electromedical devices
  • Have a stoma or colostomy
  • Show no response to abdominal FES due to lower motor neuron impairment
  • Have a history of gastrointestinal surgery within the past 3 months
  • Be severely obese with a body mass index greater than 40
  • Primary language other than English
  • History of uncontrolled, recurrent episodes of autonomic dysreflexia
  • Resting systolic blood pressure over 140 mmHg

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Craig Hospital

Englewood, Colorado, United States, 80113

Actively Recruiting

Loading map...

Research Team

C

Candy Tefertiller

CONTACT

B

Bria Mellick

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here