Clinical trial NCT06948175: Abdominal Electrical Stimulation for Bowel Dysfunction in SCI
Official title: Abdominal Transcutaneous Electrical Stimulation to Alleviate Neurogenic Bowel Dysfunction in People With Chronic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Praxis Spinal Cord Institute
name: Glenrose Foundation
First posted: 2025-04-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean defecation time at 2 weeks
timeFrame: 2 weeks after enrollment (after 2 weeks of usual bowel routine)
measure: Mean defecation time at 6 weeks
timeFrame: 6 weeks after enrollment (after 4 weeks of optimized bowel routine)
measure: Mean defecation time at 14 weeks
timeFrame: 14 weeks after enrollment (after 8 weeks of abdominal TES)
measure: Mean defecation time at 18 weeks
timeFrame: 18 weeks after enrollment (after 4 weeks of usual bowel routine)
Secondary outcomes:
measure: Bristol Stool Form
timeFrame: Every bowel routine
measure: Bowel Transit Time at 2 weeks
timeFrame: 2 weeks after enrollment (after 2 weeks of usual bowel routine)
measure: Bowel Transit Time at 6 weeks
timeFrame: 6 weeks after enrollment (after 4 weeks of optimized bowel routine)
measure: Bowel Transit Time at 14 weeks
timeFrame: 14 weeks after enrollment (after 8 weeks of abdominal TES)
measure: Bowel Transit Time at 18 weeks
timeFrame: 18 weeks after enrollment (after 4 weeks of usual bowel routine)
measure: Neurogenic Bowel Dysfunction Score (NBDS) at 2 weeks
timeFrame: 2 weeks after enrollment (after 2 weeks of usual bowel routine)
measure: Neurogenic Bowel Dysfunction Score (NBDS) at 6 weeks
timeFrame: 6 weeks after enrollment (after 4 weeks of optimized bowel routine)
measure: Neurogenic Bowel Dysfunction Score (NBDS) at 14 weeks
timeFrame: 14 weeks after enrollment (after 8 weeks of abdominal TES)
measure: Neurogenic Bowel Dysfunction Score (NBDS) at 18 weeks
timeFrame: 18 weeks after enrollment (after 4 weeks of usual bowel routine)
measure: Participant Feedback
timeFrame: 18 weeks after enrollment (end of study)
Other outcomes:
measure: ISNCSCI
timeFrame: Baseline
measure: Demographics & medical history
timeFrame: Baseline
Locations:
city: Edmonton
country: Canada
facility: Glenrose Rehabilitation Hospital
state: Alberta
Study officials:
affiliation: University of Alberta, Faculty of Medicine and Dentistry
name: Chester Ho, MD
role: PRINCIPAL_INVESTIGATOR
References: