Abdominal Electrical Stimulation for Bowel Dysfunction in SCI

Abdominal Transcutaneous Electrical Stimulation to Alleviate Neurogenic Bowel Dysfunction in People With Chronic Spinal Cord Injury

Many people with spinal cord injury (SCI) have bowel problems resulting in constipation and need a long time to empty the bowel. Some people spend an hour or more to empty their bowel. The investigators want test if using a small device to deliver electrical pulses to the belly (abdomen), would improve bowel function. The investigators hope that electrical stimulation will shorten the time needed to evacuate the bowel (defecation), improve stool consistency, and speed up food passing through the bowel. A pilot study found that electrical stimulation of the belly can speed up defecation if stimulation is making the abdominal muscles contract and squeeze the belly, which is what the investigators expected. However, some results suggested that people may benefit from low stimulation levels without making the muscles contract.

Therefore, the investigators will do small study at the University of Alberta on 12 people who lived with SCI for more than 1 year, to find out the best way to apply the electrical stimulation, and to better understand how it works. The participants will use an electrical stimulator at home, to stimulate the skin with 4 sticky pads attached over the abdomen, without causing the muscles to contract. During a 2-month period, they will use the stimulator for 30 minutes before every bowel routine. The investigators will compare how long it takes to empty the bowel, stool consistency, and how long it takes for food to pass through the bowel, with and without using the electrical stimulator.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Spinal Cord Injury
• Intervention / Treatment: Device: Abdominal transcutaneous electrical stimulation (TES)

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5G 0B7
      • Glenrose Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Traumatic or non-traumatic SCI
2. >1 year post injury
3. Injury level C2 - S5 (NLI, neurological level of injury)
4. AIS A, B, C, D (American Spinal Injury Association Impairment Scale)
5. Feels defecation takes too long and wants to do something about it
6. Defecation takes > 30 minutes

Exclusion Criteria:

1. Bladder stimulator
2. Inflammatory bowel disease
3. Pregnancy
4. Unable to give consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdominal TES; Abdominal transcutaneuous electrical stimulation (TES)	Device: Abdominal transcutaneous electrical stimulation (TES); Low-intensity sensory abdominal transcutaneous electrical stimulation (TES)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean defecation time at 2 weeks	Mean defecation time for all bowel routines from 0 to 2 weeks (2 weeks of usual bowel routine). Defecation time = time from initiation of bowel movement to the end of stool evacuation.	2 weeks after enrollment (after 2 weeks of usual bowel routine)
Mean defecation time at 6 weeks	Mean defecation time for all bowel routines from 2 to 6 weeks (4 weeks of optimized bowel routine). Defecation time = time from initiation of bowel movement to the end of stool evacuation.	6 weeks after enrollment (after 4 weeks of optimized bowel routine)
Mean defecation time at 14 weeks	Mean defecation time for all bowel routines from 6 to 14 weeks (8 weeks of abdominal TES). Defecation time = time from initiation of bowel movement to the end of stool evacuation.	14 weeks after enrollment (after 8 weeks of abdominal TES)
Mean defecation time at 18 weeks	Mean defecation time for all bowel routines from 14 to 18 weeks (4 weeks of usual bowel routine). Defecation time = time from initiation of bowel movement to the end of stool evacuation.	18 weeks after enrollment (after 4 weeks of usual bowel routine)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bristol Stool Form	The Bristol Stool Form Scale will be used to score stool form or consistency. The scale from 1-7 is scored using a 1-page document with a graphic and description of 7 different types of stool	Every bowel routine
Bowel Transit Time at 2 weeks	Bowel transit time is defined as the time from ingestion of food to time of evacuation, and will be measured using the "corn test". The participants will eat a full can of corn, on its own or with a meal, and write down the date and time of ingestion on a log sheet. They will then inspect stool after every defecation for the presence of corn kernels, and write down the date and time of the first appearance of corn in the stool	2 weeks after enrollment (after 2 weeks of usual bowel routine)
Bowel Transit Time at 6 weeks	Bowel transit time is defined as the time from ingestion of food to time of evacuation, and will be measured using the "corn test". The participants will eat a full can of corn, on its own or with a meal, and write down the date and time of ingestion on a log sheet. They will then inspect stool after every defecation for the presence of corn kernels, and write down the date and time of the first appearance of corn in the stool	6 weeks after enrollment (after 4 weeks of optimized bowel routine)
Bowel Transit Time at 14 weeks	Bowel transit time is defined as the time from ingestion of food to time of evacuation, and will be measured using the "corn test". The participants will eat a full can of corn, on its own or with a meal, and write down the date and time of ingestion on a log sheet. They will then inspect stool after every defecation for the presence of corn kernels, and write down the date and time of the first appearance of corn in the stool	14 weeks after enrollment (after 8 weeks of abdominal TES)
Bowel Transit Time at 18 weeks	Bowel transit time is defined as the time from ingestion of food to time of evacuation, and will be measured using the "corn test". The participants will eat a full can of corn, on its own or with a meal, and write down the date and time of ingestion on a log sheet. They will then inspect stool after every defecation for the presence of corn kernels, and write down the date and time of the first appearance of corn in the stool	18 weeks after enrollment (after 4 weeks of usual bowel routine)
Neurogenic Bowel Dysfunction Score (NBDS) at 2 weeks	The Neurogenic Bowel Dysfunction Score is a score from 0 to 47 documenting severity of bowel dysfunction, and is based on a 1-page form with 10 questions about frequency and time used for defecation, medication use for constipation and incontinence, use of digital stimulation, fecal incontinence and flatus, peri-anal skin problems	2 weeks after enrollment (after 2 weeks of usual bowel routine)
Neurogenic Bowel Dysfunction Score (NBDS) at 6 weeks	The Neurogenic Bowel Dysfunction Score is a score from 0 to 47 documenting severity of bowel dysfunction, and is based on a 1-page form with 10 questions about frequency and time used for defecation, medication use for constipation and incontinence, use of digital stimulation, fecal incontinence and flatus, peri-anal skin problems	6 weeks after enrollment (after 4 weeks of optimized bowel routine)
Neurogenic Bowel Dysfunction Score (NBDS) at 14 weeks	The Neurogenic Bowel Dysfunction Score is a score from 0 to 47 documenting severity of bowel dysfunction, and is based on a 1-page form with 10 questions about frequency and time used for defecation, medication use for constipation and incontinence, use of digital stimulation, fecal incontinence and flatus, peri-anal skin problems	14 weeks after enrollment (after 8 weeks of abdominal TES)
Neurogenic Bowel Dysfunction Score (NBDS) at 18 weeks	The Neurogenic Bowel Dysfunction Score is a score from 0 to 47 documenting severity of bowel dysfunction, and is based on a 1-page form with 10 questions about frequency and time used for defecation, medication use for constipation and incontinence, use of digital stimulation, fecal incontinence and flatus, peri-anal skin problems	18 weeks after enrollment (after 4 weeks of usual bowel routine)
Participant Feedback	At the end of the study, the participants participate in a semi-structured interview (in person or over the phone) to evaluate their level of satisfaction and acceptability of abdominal TES, problems that were encountered, potential benefits they perceived	18 weeks after enrollment (end of study)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ISNCSCI	A neurological assessment will be performed according to the International Standards for Neurological Classification of Spinal Cord Injury, in order to determine the ASIA Impairment Score (AIS) and neurological level of injury. The AIS score is based on manual testing of strength of 10 key muscle groups in upper and lower extremities, sensory response to light touch and pinprick at 28 key sensory points on each side of the whole body, and anal responses.	Baseline
Demographics & medical history	Demographic information, past medical history, information on SCI and current medical issues	Baseline

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Glenrose Foundation; Praxis Spinal Cord Institute
• Investigators: Principal Investigator: Chester Ho, MD, University of Alberta, Faculty of Medicine and Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: functional electrical stimulation; spinal cord injury; transcutaneous electrical stimulation; bowel dysfunction; sensory stimulation; neurogenic bowel dysfunction; abdominal electrical stimulation; defecation time; bowel transit time; stool consistency; bowel routine
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Digestive System Diseases; Gastrointestinal Diseases; Trauma, Nervous System; Spinal Cord Diseases; Intestinal Diseases; Spinal Cord Injuries
• Other Study ID Numbers: Pro00150346; G2025-13 (Other Grant/Funding Number: Praxis Spinal Cord Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No