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Enrolling by Invitation

NCT Number: NCT06948175

Abdominal Electrical Stimulation for Bowel Dysfunction in SCI

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.

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Key information

Conditions

Chronic Spinal Cord Injury Central Nervous System Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Abdominal transcutaneous electrical stimulation (TES)

Device

Low-intensity sensory abdominal transcutaneous electrical stimulation (TES)

Primary outcomes

  1. Mean defecation time at 2 weeks

    Time frame: 2 weeks after enrollment (after 2 weeks of usual bowel routine)

    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. Mean defecation time at 6 weeks

    Time frame: 6 weeks after enrollment (after 4 weeks of optimized bowel routine)

    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.

  3. Mean defecation time at 14 weeks

    Time frame: 14 weeks after enrollment (after 8 weeks of abdominal TES)

    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.

  4. Mean defecation time at 18 weeks

    Time frame: 18 weeks after enrollment (after 4 weeks of usual bowel routine)

    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.

Secondary outcomes

  1. Bristol Stool Form

    Time frame: Every bowel routine

    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

  2. Bowel Transit Time at 2 weeks

    Time frame: 2 weeks after enrollment (after 2 weeks of usual bowel routine)

    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

  3. Bowel Transit Time at 6 weeks

    Time frame: 6 weeks after enrollment (after 4 weeks of optimized bowel routine)

    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

  4. Bowel Transit Time at 14 weeks

    Time frame: 14 weeks after enrollment (after 8 weeks of abdominal TES)

    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

  5. Bowel Transit Time at 18 weeks

    Time frame: 18 weeks after enrollment (after 4 weeks of usual bowel routine)

    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. Neurogenic Bowel Dysfunction Score (NBDS) at 2 weeks

    Time frame: 2 weeks after enrollment (after 2 weeks of usual bowel routine)

    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

  7. Neurogenic Bowel Dysfunction Score (NBDS) at 6 weeks

    Time frame: 6 weeks after enrollment (after 4 weeks of optimized bowel routine)

    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

  8. Neurogenic Bowel Dysfunction Score (NBDS) at 14 weeks

    Time frame: 14 weeks after enrollment (after 8 weeks of abdominal TES)

    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

  9. Neurogenic Bowel Dysfunction Score (NBDS) at 18 weeks

    Time frame: 18 weeks after enrollment (after 4 weeks of usual bowel routine)

    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

  10. Participant Feedback

    Time frame: 18 weeks after enrollment (end of study)

    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

Other outcomes

  1. ISNCSCI

    Time frame: Baseline

    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.

  2. Demographics & medical history

    Time frame: Baseline

    Demographic information, past medical history, information on SCI and current medical issues

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Glenrose Foundation
  • Praxis Spinal Cord Institute

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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