Electrical Stimulation for Bowel Dysfunction

Overseen By Dirk Everaert, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Bladder stimulator, Inflammatory bowel disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Abdominal Electrical Stimulation for bowel dysfunction?

Research shows that electrical stimulation can help improve bowel movements in people with constipation due to spinal cord injuries and can speed up recovery of bowel function after surgery. It is also promising for treating various gastrointestinal issues by improving movement through the digestive system. ^{1 2 3 4 5}

Is electrical stimulation for bowel dysfunction safe for humans?

Electrical stimulation for bowel dysfunction has been studied for over 40 years and is generally considered safe for humans. Studies have shown it can be a promising alternative to drugs and surgery for treating gastrointestinal issues, with no major safety concerns reported in the research. ^{1 3 6 7 8}

How is Abdominal Electrical Stimulation different from other treatments for bowel dysfunction?

Abdominal Electrical Stimulation is unique because it uses electrical impulses to stimulate bowel movement, which is different from traditional drug therapies or surgical options. This non-invasive treatment can be done at home with a portable device, making it a convenient alternative for managing bowel dysfunction. ^{1 3 5 6 7}

What is the purpose of this trial?

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.

Research Team

Chester Ho, MD

Principal Investigator

University of Alberta, Faculty of Medicine and Dentistry

Eligibility Criteria

This trial is for individuals who have lived with a spinal cord injury (SCI) for over a year and are experiencing bowel dysfunction, such as constipation or incontinence. It's not specified who can't join the trial, but typically those with certain health conditions or contraindications to electrical stimulation may be excluded.

Inclusion Criteria

Defecation takes more than 30 minutes

My spinal cord injury is between C2 and S5.

My spinal injury is classified as AIS A, B, C, or D.

Exclusion Criteria

Bladder stimulator

Pregnancy

I have inflammatory bowel disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline

Collection of demographic information, past medical history, and neurological assessment

1 week

Usual Bowel Routine

Participants follow their usual bowel routine to establish baseline defecation time and bowel transit time

2 weeks

Optimized Bowel Routine

Participants follow an optimized bowel routine to improve defecation time and bowel transit time

4 weeks

Abdominal TES

Participants use abdominal transcutaneous electrical stimulation (TES) for bowel function improvement

8 weeks

Return to Usual Bowel Routine

Participants return to their usual bowel routine to assess changes post-TES

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Abdominal Electrical Stimulation

Trial Overview The study is testing abdominal transcutaneous electrical stimulation (TES) to see if it improves bowel function in people with SCI. Participants will use an at-home stimulator before their regular bowel routine for two months to determine its effectiveness on defecation time, stool consistency, and food transit through the bowels.

Participant Groups

Group I: Abdominal TES Experimental Treatment 1 Intervention

Abdominal transcutaneuous electrical stimulation (TES)

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Glenrose Foundation

Collaborator

Trials

10

Recruited

2,500+

Praxis Spinal Cord Institute

Collaborator

Trials

5

Recruited

80+

Findings from Research

Electric stimulation of bowel motor activity significantly accelerates the rehabilitation of bowel function after surgery, based on 208 stimulations performed in the study.

While it does not prevent severe functional intestinal obstruction, electric stimulation is an effective treatment method for managing such obstructions and should be routinely used in intensive postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Electric stimulation of intestinal motility in the postoperative period]. Nechaĭ, AI., Ostrovskaia, MS., Gudkov, GV., et al.[2007]

Daily transcutaneous electrical stimulation (TES) at home significantly improved bowel function in children with slow-transit constipation, increasing the average number of defecations per week from 2.5 to 6.7 episodes.

The treatment was safe, with no adverse events reported, and it may provide a novel, convenient alternative to hospital visits for managing intractable constipation in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily transabdominal electrical stimulation at home increased defecation in children with slow-transit constipation: a pilot study. Ismail, KA., Chase, J., Gibb, S., et al.[2009]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Effect of transcutaneous abdominal electrical stimulation in people with constipation due to spinal cord injuries: a pilot study. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Effect of intestinal electrical stimulation on small bowel transit: experiment with healthy volunteers]. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic Electromyography and Electrostimulation of the Gastrointestinal Tract Before Placement of Theranostic Devices. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Effects of colonic electrical stimulation using different individual parameter patterns and stimulation sites on gastrointestinal transit time, defecation, and food intake. [2018]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Electric stimulation of intestinal motility in the postoperative period]. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Daily transabdominal electrical stimulation at home increased defecation in children with slow-transit constipation: a pilot study. [2009]

7. England pubmed.ncbi.nlm.nih.gov

Electrical stimulation - an evolving concept in the treatment of colonic motor dysfunctions. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

A review of electrical stimulation to treat motility dysfunctions in the digestive tract: effects and stimulation patterns. [2022]