Chronic Spinal Cord InjuryNCT06948175
Abdominal Electrical Stimulation for Bowel Dysfunction in SCI
A study testing Abdominal transcutaneous electrical stimulation (TES) in people with Chronic Spinal Cord Injury, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Spinal Cord Injury
- What is being tested?
- Abdominal transcutaneous electrical stimulation (TES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bladder stimulator
- Inflammatory bowel disease
- Pregnancy
- Unable to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Chronic Spinal Cord Injury
- Being tested
- Abdominal transcutaneous electrical stimulation (TES)
- 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
- Medical subject headings
- Spinal Cord Injuries, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal transcutaneous electrical stimulation (TES)Device
Low-intensity sensory abdominal transcutaneous electrical stimulation (TES)
| Study group | Role | What they receive |
|---|---|---|
| Abdominal TES | Experimental | Abdominal transcutaneuous electrical stimulation (TES) Receives: Device: Abdominal transcutaneous electrical stimulation (TES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 weeks after enrollment (after 4 weeks of usual bowel routine)
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 weeks after enrollment (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start14 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Praxis Spinal Cord Institute, Glenrose Foundation
- Responsible party
- Sponsor
- Investigators
- Chester Ho, MD, Principal investigator, University of Alberta, Faculty of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948175
- Sponsor's protocol ID
- Pro00150346
- Other IDs
- G2025-13
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Transcutaneous Electrical Stimulation to Alleviate Neurogenic Bowel Dysfunction in People With Chronic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06948175
- Acronym / sponsor ID
- Pro00150346
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Praxis Spinal Cord Institute, Glenrose Foundation
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Abdominal TES | Experimental | Device: Abdominal transcutaneous electrical stimulation (TES)Abdominal transcutaneuous electrical stimulation (TES) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Bladder stimulator
- Inflammatory bowel disease
- Pregnancy
- Unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal transcutaneous electrical stimulation (TES)Low-intensity sensory abdominal transcutaneous electrical stimulation (TES) | Device | Abdominal TES |
Primary outcome
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.
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.
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.
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.
10 secondary outcomes
Bristol Stool Form
Time frame: Every bowel routine
Bowel Transit Time at 2 weeks
Time frame: 2 weeks after enrollment (after 2 weeks of usual bowel routine)
Bowel Transit Time at 6 weeks
Time frame: 6 weeks after enrollment (after 4 weeks of optimized bowel routine)
Bowel Transit Time at 14 weeks
Time frame: 14 weeks after enrollment (after 8 weeks of abdominal TES)
Bowel Transit Time at 18 weeks
Time frame: 18 weeks after enrollment (after 4 weeks of usual bowel routine)
Neurogenic Bowel Dysfunction Score (NBDS) at 2 weeks
Time frame: 2 weeks after enrollment (after 2 weeks of usual bowel routine)
Neurogenic Bowel Dysfunction Score (NBDS) at 6 weeks
Time frame: 6 weeks after enrollment (after 4 weeks of optimized bowel routine)
Neurogenic Bowel Dysfunction Score (NBDS) at 14 weeks
Time frame: 14 weeks after enrollment (after 8 weeks of abdominal TES)
Neurogenic Bowel Dysfunction Score (NBDS) at 18 weeks
Time frame: 18 weeks after enrollment (after 4 weeks of usual bowel routine)
Participant Feedback
Time frame: 18 weeks after enrollment (end of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chester Ho, MD principal investigator
University of Alberta, Faculty of Medicine and Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal transcutaneous electrical stimulation (TES) in people with Chronic Spinal Cord Injury, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean defecation time at 2 weeks (time frame: 2 weeks after enrollment (after 2 weeks of usual bowel routine)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.