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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with spinal cord injuries who experience constipation and prolonged bowel movements. Researchers aim to determine if a small device that delivers gentle electrical pulses to the abdomen (abdominal electrical stimulation) can speed up bowel movements and improve stool consistency. Participants will use this device at home for 30 minutes before each bowel routine over a two-month period. The trial seeks individuals who have lived with spinal cord injuries for more than a year and find their bowel movements take longer than 30 minutes. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily life for those with spinal cord injuries.

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 prior data suggests that this device is safe for improving bowel function in people with spinal cord injury?

Research has shown that electrical stimulation on the abdomen is generally safe and well-tolerated. One study found it can help with constipation by improving bowel movements and reducing the need for medications. This method is noninvasive, requiring no surgery, and drug-free, allowing for home use. Another study demonstrated it could help food move through the gut faster without causing major issues.

While these studies indicate promising safety results, this treatment is still under investigation, particularly for individuals with spinal cord injuries. Its presence in a trial means researchers are still gathering more safety information. However, current data suggests minimal side effects. Always consult a healthcare provider to determine if this option is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for bowel dysfunction, which often include dietary changes, medications, or even surgery, abdominal transcutaneous electrical stimulation (TES) offers a non-invasive alternative. This method uses electrical currents applied to the skin to stimulate the abdominal muscles and improve bowel function. Researchers are excited about this approach because it targets the condition in a novel way, potentially offering relief without the side effects associated with more invasive or systemic treatments. Additionally, TES could provide a more convenient option for patients, as it can be administered without the need for hospitalization or complex procedures.

What evidence suggests that this device is effective for bowel dysfunction?

Research has shown that electrical stimulation on the abdomen might help with bowel issues by speeding up food movement through the gut and easing bowel movements. Participants in this trial will receive abdominal transcutaneous electrical stimulation (TES). Studies have demonstrated that TES results in faster bowel emptying and better stool consistency. This noninvasive technique, which doesn't involve surgery or drugs, offers a convenient option for managing these problems. Additionally, it has improved the quality of life for people with constipation. Overall, these findings suggest that electrical stimulation could effectively manage bowel problems in people with spinal cord injuries. ^{2 3 4 6 7}

Who Is on the Research Team?

Chester Ho, MD

Principal Investigator

University of Alberta, Faculty of Medicine and Dentistry

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37288650/

Transcutaneous electrical stimulation for gastrointestinal ...

Methods: This review paper navigates through the different TES techniques, including transcutaneous peripheral nerve (vagal/sacral/tibial nerves) electrical ...

2.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/nmo.14618

Transcutaneous electrical stimulation for gastrointestinal ...

TES, a noninvasive, nonpharmaceutical, nonsurgical, and home-based self-administrative technique in managing GI motility disorders.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1094715924012170

Efficacy and Safety of Noninvasive Electrical ...

NEN relieves constipation symptoms, improves quality of life, and reduces use of pharmacologic remedies in adults with FC.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8529907/

The effect of abdominal functional electrical stimulation on ...

This study aims to evaluate the efficacy of abdominal functional electrical stimulation to reduce whole gut and colonic transit times and improve bowel and ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT4349891

Transcutaneous Electroacupuncture for Gastrointestinal ...

Electroacupuncture (EA) at PC6 and ST36 has been reported to accelerate gastrointestinal motility in both animals and human. Recently, the investigators have ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06948175?term=bowel%20sci&viewType=Table&rank=3

Abdominal Electrical Stimulation for Bowel Dysfunction in SCI

Defecation takes > 30 minutes. Exclusion Criteria: Bladder stimulator; Inflammatory bowel disease; Pregnancy; Unable to give consent. Ages Eligible for Study.

7.

journals.lww.com

journals.lww.com/ajg/fulltext/2022/09000/transcutaneous_electrical_acustimulation_improves.25.aspx

Transcutaneous Electrical Acustimulation Improves Irritable ...

TEA improves constipation and symptoms of IBS by accelerating colon transit and reducing rectal sensation, possibly mediated by using the autonomic mechanisms.