Abdominal Electrical Stimulation for Bowel Dysfunction in SCI

University of Alberta

Status: Invitation-only

Conditions: Chronic Spinal Cord Injury

Treatments: Device: Abdominal transcutaneous electrical stimulation (TES)

Study type: Interventional

Funder types: Other

Identifiers

NCT06948175

G2025-13 (Other Grant/Funding Number)

Pro00150346

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Abdominal TES

Experimental group

Description:

Abdominal transcutaneuous electrical stimulation (TES)

Treatment:

Device: Abdominal transcutaneous electrical stimulation (TES)