Abdominal Electrical Stimulation for Bowel Dysfunction in SCI

NCT06948175 | Enrolling By Invitation

• 2 other identifiers: Pro00150346G2025-13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Spinal Cord Injury

Keywords

spinal cord injury; functional electrical stimulation; transcutaneous electrical stimulation; neurogenic bowel dysfunction; bowel dysfunction; abdominal electrical stimulation; sensory stimulation; defecation time; bowel transit time; stool consistency; bowel routine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Bristol Stool Form

  Every bowel routine

• Bowel Transit Time at 2 weeks

  2 weeks after enrollment (after 2 weeks of usual bowel routine)

• Bowel Transit Time at 6 weeks

  6 weeks after enrollment (after 4 weeks of optimized bowel routine)

• Bowel Transit Time at 14 weeks

  14 weeks after enrollment (after 8 weeks of abdominal TES)

• Bowel Transit Time at 18 weeks

  18 weeks after enrollment (after 4 weeks of usual bowel routine)

Other Outcomes (2)

• ISNCSCI

  Baseline

• Demographics & medical history

  Baseline

Study Arms (1)

Abdominal TES

EXPERIMENTAL

Abdominal transcutaneuous electrical stimulation (TES)

Device: Abdominal transcutaneous electrical stimulation (TES)

Interventions

Abdominal transcutaneous electrical stimulation (TES) DEVICE

Low-intensity sensory abdominal transcutaneous electrical stimulation (TES)

Abdominal TES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Bladder stimulator
• Inflammatory bowel disease
• Pregnancy
• Unable to give consent

Sponsors & Collaborators

• University of Alberta: lead
• Praxis Spinal Cord Institute: collaborator
• Glenrose Foundation: collaborator

Study Sites (1)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Intestinal Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Chester Ho, MD

  University of Alberta, Faculty of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study uses an interrupted time-series design with 4 phases of observation and 3 changes in condition in a single group of participants. The conditions per phase and phase durations are as follows: Phase 1 (duration 2 weeks): Participants apply their usual bowel routine for baseline observation. Phase 2 (duration 4 weeks): In case that the initial assessment resulted in recommendations for improvement to the participant's usual bowel routine (See 2. Interventions), participants apply their optimized bowel routine in Phase 2 for 4 weeks. If no bowel routine adjustment was recommended, Phase 2 is omitted. Phase 3 (duration 8 weeks): Participants apply abdominal TES for 30 minutes prior to every bowel routine. In case the bowel routine was optimized, they keep applying the optimized bowel routine. Phase 4 (duration 4 weeks): Participants go back to their optimized bowel routine only, without using abdominal TES.

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 29, 2025
• Study Start: July 14, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

CA (1)