Electrical Stimulation for Spinal Cord Injury

Overseen By Bria Mellick

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Craig Hospital

Disqualifiers: Bowel conditions, Obesity, Gastrointestinal surgery, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether abdominal functional electrical stimulation (FES) can help individuals with long-term spinal cord injuries manage bowel movements more effectively and improve related issues such as bladder symptoms and quality of life. Participants will share their experiences with the treatment to help researchers understand its impact. Ideal candidates have had a spinal cord injury for over a year, face bowel management challenges, and can use a smart device with internet access. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could significantly enhance the quality of life for individuals with spinal cord injuries.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team to get a clear answer.

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

Research has shown that Abdominal Functional Electrical Stimulation (FES) is generally well-tolerated by people with spinal cord injuries (SCI). Studies have found that this noninvasive treatment, which does not break the skin, can improve bowel function and assist with breathing problems. Reports of harmful side effects are minimal. Instead, the treatment aims to enhance quality of life by simplifying bowel management and reducing hospital visits. This suggests that Abdominal FES is safe for humans, particularly since it has been tested in other contexts before. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Abdominal Functional Electrical Stimulation is unique because it offers a new way to help people with spinal cord injuries by using electrical impulses to stimulate muscles in the abdomen. Unlike standard treatments that focus on physical rehabilitation or medication, this method directly activates muscles to improve core stability and potentially enhance mobility. Researchers are excited about this approach because it targets muscle function in a way that current therapies do not, offering hope for improved quality of life for those affected by spinal cord injuries.

What evidence suggests that abdominal FES is effective for improving bowel management time in chronic SCI?

Research has shown that electrical stimulation on the abdomen can improve bowel function for people with spinal cord injuries. This simple, noninvasive method may also reduce complications and enhance quality of life. Studies have found it can boost breathing, benefiting overall health. Additionally, this technique might improve muscle health and fitness in people with spinal cord injuries. Overall, evidence suggests that abdominal electrical stimulation can positively impact managing issues related to spinal cord injuries. In this trial, all participants will receive Abdominal Functional Electrical Stimulation to further evaluate its effectiveness. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic spinal cord injury who experience neurogenic bowel dysfunction. It aims to help them manage their bowel function better and improve their quality of life related to bowel management.

Inclusion Criteria

Willingness to access and/or download Zoom (videoconferencing software)

I am older than 18 years.

My spinal cord injury is above T11 and happened over a year ago.

Exclusion Criteria

Self-reported bowel management time (BMT) of <30 minutes

Physical obstacles that prevent AFES (e.g., pregnancy, abdominal trauma, cardiac pacemaker, or other implanted electromedical devices)

Primary language other than English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abdominal functional electrical stimulation to improve bowel management time

10 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abdominal Functional Electrical Stimulation

Trial Overview The study tests the effectiveness of Abdominal Functional Electrical Stimulation (FES) in reducing the time needed for bowel management, enhancing quality of life, improving bladder symptoms, and potentially decreasing unplanned hospital visits.

How Is the Trial Designed?

Group I: Abdominal Functional Electrical Stimulation Experimental Treatment 1 Intervention

All participants enrolled will receive the intervention.

Who Is Running the Clinical Trial?

Craig Hospital

Lead Sponsor

Trials

45

Recruited

8,400+

Neuroscience Research Australia

Collaborator

Trials

14

Recruited

1,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9678222/

Effectiveness of Abdominal Functional Electrical Stimulation ... A noninvasive intervention that improves the bowel function of people with an SCI should reduce morbidity, improve quality of life, and lead to cost savings.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31068742/

Abdominal Functional Electrical Stimulation to Augment ... Objective: The aim of the article is to provide readers with a better understanding of how abdominal FES can be used to improve the health of the spinal cord- ...

3. nature.com nature.com/articles/sc201631

Abdominal functional electrical stimulation to improve ... This systematic review suggests that abdominal FES is an effective technique for improving respiratory function in both an acute and chronic manner after SCI.

4. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2025.1623752/pdf

Efficacy of functional electrical stimulation alone and as an ... Twelve studies investigated the effect of functional electrical stimulation (FES) on respiratory function in individuals with spinal cord injury ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00882-8

Functional electrical stimulation cycling exercise after spinal ... Current evidence indicates that FES cycling exercise improves lower-body muscle health of adults with SCI, and may increase power output and aerobic fitness.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4519233/

Functional Electrical Stimulation and Spinal Cord Injury - PMC Respiratory effects of combined truncal and abdominal support in patients with spinal cord injury. ... safety trial, technical note, and lumbar safety outcomes.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04307303

Electrical Stimulation of Abdominal Muscles for Bowel ... The study will include 36 people with a spinal cord injury aged 18 and over with an above T12 injury, a complete or incomplete lesion in a medically stable ...