Abdominal Electrical Stimulation for Bowel Dysfunction in SCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-14

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury

NCT06345781

Spinal Cord Injuries Neurogenic Bowel

RECRUITING NA

Stimulation for Bowel Emptying

NCT06078176

Neurogenic Bowel Dysfunction

RECRUITING NA

The Effect of NMES on Bowel Management in People with Chronic SCI

NCT04914975

Electric Stimulation Therapy Bowel Dysfunction Spinal Cord Injuries +1 more

COMPLETED NA

Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury

NCT00286520

Constipation Fecal Incontinence Spinal Cord Injury

COMPLETED PHASE4

Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury

NCT05267951

Spinal Cord Injuries

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Abdominal TES

Abdominal transcutaneuous electrical stimulation (TES)

Group Type EXPERIMENTAL

Abdominal transcutaneous electrical stimulation (TES)

Intervention Type DEVICE

Low-intensity sensory abdominal transcutaneous electrical stimulation (TES)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Abdominal transcutaneous electrical stimulation (TES)

Low-intensity sensory abdominal transcutaneous electrical stimulation (TES)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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