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Enrolling by invitation NCT06948175

Abdominal Electrical Stimulation for Bowel Dysfunction in SCI

No phase Interventional Chronic Spinal Cord Injury

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Abdominal transcutaneous electrical stimulation (TES).
Who it may be relevant to
Registry conditions: Chronic Spinal Cord Injury. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device Abdominal transcutaneous electrical stimulation (TES)
    Low-intensity sensory abdominal transcutaneous electrical stimulation (TES)

Primary outcome measures

  • Mean defecation time at 2 weeks [Time frame: 2 weeks after enrollment (after 2 weeks of usual bowel routine)]
  • Mean defecation time at 6 weeks [Time frame: 6 weeks after enrollment (after 4 weeks of optimized bowel routine)]
  • Mean defecation time at 14 weeks [Time frame: 14 weeks after enrollment (after 8 weeks of abdominal TES)]
  • Mean defecation time at 18 weeks [Time frame: 18 weeks after enrollment (after 4 weeks of usual bowel routine)]
Secondary outcome measures (10)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Glenrose Rehabilitation Hospital — Edmonton

Identifiers

NCT: NCT06948175 · Pro00150346 · G2025-13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗